tag:blogger.com,1999:blog-49970101204174701072024-03-02T17:45:44.459-08:00Farmasi Industri IndonesiaTempat berbagi ilmu dan silaturahmi antar pharmacist IndonesiaAndi Usman Pharmahttp://www.blogger.com/profile/00236524553139613509noreply@blogger.comBlogger27125tag:blogger.com,1999:blog-4997010120417470107.post-57283833955859875162013-02-20T22:52:00.000-08:002013-02-20T22:52:09.948-08:00Product Quality Review / Peninjauan Kualitas Produk<br />
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<span lang="EN-US" style="font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 200%; mso-bidi-font-family: Calibri;"><i>Product Quality Review </i>(PQR) / <i>Annual Product Review </i>(Peninjauan Produk tahunan) dapat didefinisikan kajian mutu produk secara berkala yang
dilakukan terhadap semua obat terdaftar, termasuk produk ekspor, dengan tujuan
untuk membuktikan konsistensi proses, kesesuaian dari spesifikasi bahan awal,
bahan pengemas, dan obat jadi, untuk melihat tren dan mengidentifikasi
perbaikan yang diperlukan untuk produk dan proses (Anonim, 2006).<o:p></o:p></span></div>
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<span lang="EN-US" style="font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 200%; mso-bidi-font-family: Calibri;">Penyusunan atau pembuatan PQR dapat berfungsi untuk :<o:p></o:p></span></div>
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<!--[if !supportLists]--><span lang="EN-US" style="font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 200%; mso-fareast-font-family: "Times New Roman";">a.<span style="font-family: 'Times New Roman'; font-size: 7pt; line-height: normal;">
</span></span><!--[endif]--><span lang="EN-US" style="font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 200%; mso-bidi-font-family: Calibri;">Menurunkan resiko dari hasil yang tidak memenuhi spek (<i>out</i>-<i>of</i>-<i>specification</i>)<o:p></o:p></span></div>
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<span lang="EN-US" style="font-family: 'Times New Roman', serif; font-size: 12pt; line-height: 200%;">a<i>.</i><span style="font-family: 'Times New Roman'; font-size: 7pt; font-style: normal; line-height: normal;">
</span></span><!--[endif]--><span lang="EN-US" style="font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 200%; mso-bidi-font-family: Calibri;">Meminimalkan resiko <i>rework</i>
atau <i>reprocessing<o:p></o:p></i></span></div>
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<!--[if !supportLists]--><span lang="EN-US" style="font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 200%; mso-fareast-font-family: "Times New Roman";">b.<span style="font-family: 'Times New Roman'; font-size: 7pt; line-height: normal;"> </span></span><!--[endif]--><span lang="EN-US" style="font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 200%; mso-bidi-font-family: Calibri;">Meningkatkan hasil produksi<o:p></o:p></span></div>
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<!--[if !supportLists]--><span lang="EN-US" style="font-family: 'Times New Roman', serif; font-size: 12pt; line-height: 200%;">c<i>.</i><span style="font-family: 'Times New Roman'; font-size: 7pt; font-style: normal; line-height: normal;">
</span></span><!--[endif]--><span lang="EN-US" style="font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 200%; mso-bidi-font-family: Calibri;">Menurunkan terjadinya produk <i>recalls<o:p></o:p></i></span></div>
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<!--[if !supportLists]--><span lang="EN-US" style="font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 200%; mso-fareast-font-family: "Times New Roman";">d.<span style="font-family: 'Times New Roman'; font-size: 7pt; line-height: normal;"> </span></span><!--[endif]--><span lang="EN-US" style="font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 200%; mso-bidi-font-family: Calibri;">Memperbaiki komunikasi antara produksi, <i>quality</i>, tehnik, dan fungsi regulasi
(Haslam, 2006)<o:p></o:p></span></div>
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<span lang="EN-US" style="font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 200%; mso-bidi-font-family: Calibri;">Peninjauan mutu secara berkala biasanya dilakukan setiap tahun dan
didokumentasikan, dengan memperhatikan hasil kajian ulang sebelumnya, dan
hendaklah mencakup paling sedikit: <o:p></o:p></span></div>
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<!--[if !supportLists]--><span lang="EN-US">a.<span style="font-size: 7pt; line-height: normal;">
</span></span><!--[endif]--><span lang="EN-US">Tinjauan terhadap bahan awal
dan bahan pengemas yang digunakan untuk produk, terutama dari sumber yang baru </span></div>
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<!--[if !supportLists]--><span lang="EN-US">b.<span style="font-size: 7pt; line-height: normal;">
</span></span><!--[endif]--><span lang="EN-US">Tinjauan terhadap pengawasan
selama proses yang kritis dan hasil uji obat jadi </span></div>
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<!--[if !supportLists]--><span lang="EN-US">c.<span style="font-size: 7pt; line-height: normal;">
</span></span><!--[endif]--><span lang="EN-US">Tinjauan terhadap semua <i>batch
</i>yang tidak sesuai dengan spesifikasi yang ditetapkan dan investigasi yang
dilakukan </span></div>
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<!--[if !supportLists]--><span lang="EN-US">d.<span style="font-size: 7pt; line-height: normal;">
</span></span><!--[endif]--><span lang="EN-US">Tinjauan terhadap semua
penyimpangan atau ketidaksesuaian yang signifikan, investigasinya dan
efektivitas hasil tindakan perbaikan dan pencegahan yang dilakukan</span></div>
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<!--[if !supportLists]--><span lang="EN-US">e.<span style="font-size: 7pt; line-height: normal;">
</span></span><!--[endif]--><span lang="EN-US">Tinjauan terhadap semua
perubahan yang dilakukan terhadap proses atau metode analisis </span></div>
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<!--[if !supportLists]--><span lang="EN-US">f.<span style="font-size: 7pt; line-height: normal;">
</span></span><!--[endif]--><span lang="EN-US">Tinjauan terhadap variasi yang
diajukan, disetujui, ditolak termasuk dokumen registrasi untuk produk ekspor </span></div>
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<!--[if !supportLists]--><span lang="EN-US">g.<span style="font-size: 7pt; line-height: normal;">
</span></span><!--[endif]--><span lang="EN-US">Tinjauan terhadap hasil program
pengamatan stabilitas dan segala tren yang menyimpang </span></div>
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<!--[if !supportLists]--><span lang="EN-US">h.<span style="font-size: 7pt; line-height: normal;">
</span></span><!--[endif]--><span lang="EN-US">Tinjauan terhadap semua produk
kembalian, keluhan dan penarikan obat yang terkait dengan mutu produk, termasuk
investigasi yang telah dilakukan </span></div>
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<!--[if !supportLists]--><span lang="EN-US">i.<span style="font-size: 7pt; line-height: normal;">
</span></span><!--[endif]--><span lang="EN-US">Tinjauan kelayakan terhadap
tindakan perbaikan proses produk atau peralatan yang sebelumnya </span></div>
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<!--[if !supportLists]--><span lang="EN-US">j.<span style="font-size: 7pt; line-height: normal;">
</span></span><!--[endif]--><span lang="EN-US">Pada obat yang baru mendapatkan
persetujuan pendaftaran dan obat dengan persetujuan pendaftaran variasi, perlu
ada tinjauan terhadap komitmen pasca pemasaran</span></div>
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<!--[if !supportLists]--><span lang="EN-US">k.<span style="font-size: 7pt; line-height: normal;">
</span></span><!--[endif]--><span lang="EN-US">Status kualifikasi peralatan
dan sarana yang relevan misal HVAC, air, gas bertekanan, dll </span></div>
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<!--[if !supportLists]--><i><span lang="EN-US">l.<span style="font-size: 7pt; font-style: normal; line-height: normal;">
</span></span></i><!--[endif]--><span lang="EN-US">Tinjauan terhadap
kesepakatan teknis untuk memastikan selalu <i>up to date <o:p></o:p></i></span></div>
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<span lang="EN-US">(Anonim, 2009)</span></div>
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<span lang="EN-US" style="font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 200%; mso-bidi-font-family: Calibri;">Industri dan pemegang izin edar hendaklah melakukan evaluasi terhadap
hasil tinjauan ini, dan membuat suatu penilaian untuk menentukan apakah
tindakan perbaikan dan pencegahan ataupun validasi ulang harus dilakukan.
Alasan tindakan perbaikan yang dilakukan harus didokumentasikan. Tindakan
perbaikan dan pencegahan yang telah disetujui hendaklah diselesaikan dengan
cara yang efektif sesuai dengan waktu yang ditetapkan. Tinjauan mutu dapat
dikelompokkan menurut jenis produk, misal sediaan padat, cair, steril, dan
lain-lain (Anonim, 2009). <o:p></o:p></span></div>
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<b style="font-family: 'Times New Roman', serif; font-size: 12pt; line-height: 200%; text-indent: 36pt;"><span lang="EN-US" style="font-size: 12pt; line-height: 200%;">DAFTAR PUSTAKA</span></b></div>
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<span lang="EN-US" style="font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 200%; mso-bidi-font-family: Calibri;">
</span></div>
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<span lang="EN-US" style="font-size: 12pt;"><span style="font-size: 12pt; line-height: 200%; text-indent: 36pt;">Anonim, 2006, </span><i style="font-size: 12pt; line-height: 200%; text-indent: 36pt;">Pedoman Cara Pembuatan Obat yang Baik</i><span style="font-size: 12pt; line-height: 200%; text-indent: 36pt;">, Jakarta, Badan POM</span></span></div>
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<span lang="EN-US" style="font-size: 12pt;">Anonim, 2009, <i>Guide to Good Manufacturing</i> <i>Practice for Medicinal Products</i> <i>Part I, </i>Geneva, PIC/S (<i>Pharmaceutical
inspection convention </i>/<i>
Pharmaceutical inspection co-operation scheme</i>).</span><span style="font-size: 12pt; text-indent: -36pt;"> </span></div>
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<span lang="EN-US" style="font-size: 12pt;">Haslam, R.,
2006, </span><i><span lang="EN-US" style="font-size: 12pt;">Product
Quality Reviews</span></i><span lang="EN-US" style="font-size: 12pt;">, </span><span lang="EN-US"><a href="http://www.pharmaceutical-int.com/article/product-quality-reviews.html">http://www.pharmaceutical-int.com/article/product-quality-reviews.html</a></span><span lang="EN-US" style="font-size: 12pt;">, Diakses pada 7 Februari 2010<o:p></o:p></span></div>
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<br /></div>
<br />
Andi Usman Pharmahttp://www.blogger.com/profile/00236524553139613509noreply@blogger.com0tag:blogger.com,1999:blog-4997010120417470107.post-11333540943325836672013-02-07T05:47:00.000-08:002013-02-10T07:03:42.249-08:00Validasi Metode Analisa<br />
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<span lang="EN-US">CPOB mensyaratkan industri farmasi untuk
mengidentifikasi validasi yang perlu dilakukan sebagai bukti pengendalian
terhadap aspek kritis dari kegiatan yang dilakukan. Perubahan signifikan
terhadap fasilitas, peralatan dan proses yang dapat mempengaruhi mutu produk
hendaklah divalidasi. Validasi merupakan tindakan pembuktian dengan cara yang untuk
dilakukan karena dengan validasi ini kita dapat mengetahui kesesuaian suatu
metode analisis dengan tujuan penggunaannya (Badan POM, 2006).sesuai bahwa tiap
bahan, proses, prosedur, kegiatan, sistem, perlengkapan atau mekanisme yang
digunakan dalam produksi maupun pengawasan mutu akan senantiasa mencapai hasil
yang diinginkan (Badan POM, 2006).</span><o:p></o:p></div>
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<b> </b><span lang="FI">Tujuan utama yang harus dicapai oleh suatu
laboratorium pengujian adalah dihasilkannya data hasil uji yang absah (valid).
Secara sederhana hasil uji yang absah dapat digambarkan sebagai hasil uji yang
mempunyai akurasi dan presisi yang baik. Pada proses analisis, disamping
pengujiannya harus dilakukan oleh tenaga kerja yang telah diberikan pelatihan
dengan sarana dan prasarana yang menunjang, penggunaan metode yang valid juga
memegang peranan penting agar diperoleh data yang dapat dipercaya (valid).
Untuk mengetahui suatu metode analisis valid atau tidaknya dapat diketahui
melalui validasi metode analisis </span>atau <i>analytical method validation</i><span lang="FI" style="line-height: 150%;">.</span><b style="line-height: 150%;"><span lang="EN-US"> </span></b></div>
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<span class="a"><span lang="EN-US"> Validasi metode
analisa</span></span><span class="a"> atau <i>analytical method validation</i><span lang="EN-US"> menurut </span></span><span lang="EN-US">SNI 19-17025-2000 adalah
konfirmasi pengujian dan pengadaan bukti yang objektif bahwa persyaratan
tertentu untuk suatu maksud khusus dipenuhi. Validasi metode analisa bertujuan
untuk membuktikan bahwa semua metode analisa yang digunakan dalam pengujian
maupun pengawasan mutu, senantiasa mencapai hasil yang diinginkan secara
konsisten. <o:p></o:p></span></div>
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<span lang="EN-US"> Validasi biasanya diperuntukkan
untuk metode analisa yang baru dibuat dan dikembangkan, sedangkan untuk metode
yang memang telah tersedia dan baku namun metode tersebut baru pertama kali
akan digunakan di laboratorium tertentu, biasanya tidak perlu dilakukan
validasi, namun hanya verifikasi. Tahapan verifikasi mirip dengan validasi
hanya saja parameter yang dilakukan tidak selengkap validasi (Riyadi, 2009).</span></div>
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<span lang="EN-US"> Validasi metode analisa dilakukan untuk semua
metode analisa yang digunakan untuk pengawasan kegiatan produksi. Dilakukan
dengan semua peralatan yang telah dikalibrasi dan diuji kesesuaian sistemnya
dan menggunakan baku pembanding yang sudah dibakukan dan disimpan di tempat
yang sesuai. Suatu metode analisa perlu divalidasi apabila </span>:<o:p></o:p></div>
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<span lang="EN-US">* Suatu metode tersebut harus dikembangkan untuk suatu permasalahan
yang khusus,<o:p></o:p></span></div>
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<span lang="EN-US">* Metode yang selama ini sudah rutin direvisi untuk suatu
pengembangan atau diperluas untuk memecahkan suatu permasalahan analisa yang
baru,<o:p></o:p></span></div>
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<span lang="EN-US">* Hasil <i>quality </i></span><i>c<span lang="EN-US">ontrol</span></i><span lang="EN-US"> menunjukkan bahwa metode yang
sudah rutin tersebut berubah terhadap waktu,<o:p></o:p></span></div>
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<span lang="EN-US">* Metode rutin yang digunakan di laboratorium yang berbeda atau
dilakukan oleh analis yang berbeda atau dilakukan dengan peralatan yang
berbeda.<o:p></o:p></span></div>
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<span lang="EN-US"> Menurut USP, parameter-parameter
dalam validasi metode analisis yaitu :<o:p></o:p></span></div>
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<!--[if !supportLists]--><span lang="EN-US">1.<span style="font-size: 7pt; line-height: normal;"> </span></span><!--[endif]--><span lang="EN-US">Akurasi (Kecermatan)<o:p></o:p></span></div>
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<span lang="EN-US">Ukuran
yang menunjukkan derajat kedekatan hasil analisis dengan kadar analit yang
sebenarnya. Akurasi dinyatakan dengan persentase perolehan kembali (<i>recovery</i>). <o:p></o:p></span></div>
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<!--[if !supportLists]--><span lang="EN-US">2.<span style="font-size: 7pt; line-height: normal;"> </span></span><!--[endif]--><span lang="EN-US">Presisi (Keterulangan)<o:p></o:p></span></div>
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<span lang="EN-US">Merupakan
ukuran keterulangan metode analisis dan biasanya diekspresikan sebagai
simpangan baku relatif. <o:p></o:p></span></div>
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<!--[if !supportLists]--><span lang="EN-US">3.<span style="font-size: 7pt; line-height: normal;">
</span></span><!--[endif]--><span lang="EN-US">Spesifisitas
(Selektifitas)<o:p></o:p></span></div>
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<span lang="EN-US">Parameter
ini untuk melihat ada atau tidak adanya interfensi dari <i>excipient</i>s terhadap respon dari analit.<o:p></o:p></span></div>
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<!--[if !supportLists]--><span lang="EN-US">4.<span style="font-size: 7pt; line-height: normal;">
</span></span><!--[endif]--><span lang="EN-US">Linearitas<o:p></o:p></span></div>
<div class="MsoNormal" style="line-height: 150%; margin-left: 54.0pt; tab-stops: 54.0pt; text-align: justify; text-autospace: ideograph-numeric;">
<span lang="EN-US">Merupakan
kemampuan suatu metode analisis untuk menunjukkan hubungan secara langsung atau
proporsional antara respons detektor dengan perubahan konsentrasi analit. <o:p></o:p></span></div>
<div class="MsoNormal" style="line-height: 150%; margin-left: 2.0cm; mso-list: l1 level1 lfo2; tab-stops: 54.0pt; text-align: justify; text-autospace: ideograph-numeric; text-indent: -21.25pt;">
<!--[if !supportLists]--><span lang="EN-US">5.<span style="font-size: 7pt; line-height: normal;">
</span></span><!--[endif]--><span lang="EN-US">Batas Deteksi (<i>Limit of Detection/LOD</i>)<o:p></o:p></span></div>
<div class="MsoNormal" style="line-height: 150%; margin-left: 54.0pt; tab-stops: 54.0pt; text-align: justify; text-autospace: ideograph-numeric;">
<span lang="EN-US">Merupakan
konsentrasi terkecil dari analit yang masih dapat terdeteksi dari suatu metode
analisa.<o:p></o:p></span></div>
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<!--[if !supportLists]--><span lang="EN-US">6.<span style="font-size: 7pt; line-height: normal;">
</span></span><!--[endif]--><span lang="EN-US">Batas Kuantitasi (<i>Limit of Quantitation/LOQ</i>)<o:p></o:p></span></div>
<div class="MsoNormal" style="line-height: 150%; margin-left: 54.0pt; tab-stops: 54.0pt; text-align: justify; text-autospace: ideograph-numeric;">
<span lang="EN-US">Merupakan
konsentrasi terkecil dari analit yang masih dapat terkuantifikasi<o:p></o:p></span></div>
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<!--[if !supportLists]--><span lang="EN-US">7.<span style="font-size: 7pt; line-height: normal;">
</span></span><!--[endif]--><i><span lang="EN-US">Ruggedness & Robustness</span></i><span lang="EN-US"> (Kekuatan
& Ketahanan)<o:p></o:p></span></div>
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<span lang="EN-US">Kedua
parameter ini menunjukkan kekuatan dan ketahanan dari metode analisa. Variasi
yang dapat digunakan pada <i>Ruggedness</i>
antara lain variasi analis/instrumen/waktu analisa. Sedangkan untuk parameter <i>Robustness</i> dapat dilakukan sedikit
modifikasi pada suatu proses yang dianggap <i>critical </i>dan sebaiknya
digunakan sampel produksi untuk mendapatkan gambaran yang sebenarnya mengenai
analisa terhadap obat jadi.<o:p></o:p></span></div>
Andi Usman Pharmahttp://www.blogger.com/profile/00236524553139613509noreply@blogger.com0tag:blogger.com,1999:blog-4997010120417470107.post-17240018498303809502013-01-30T06:58:00.000-08:002013-02-01T06:21:49.742-08:00Produk afkiran/ penolakan dan produk kembalian dalam CDOB<br />
<span style="font-family: TimesNewRomanPSMT, serif; font-size: 16px; line-height: 24px; text-align: justify;">Prinsip </span><span style="font-family: TimesNewRomanPSMT, serif; font-size: 12pt; text-align: center;">produk afkiran/ penolakan dan produk
kembalian </span><span style="font-family: TimesNewRomanPSMT, serif; font-size: 16px; line-height: 24px; text-align: justify;">dalam Cara Distribusi yang Baik (CDOB) / </span><i style="font-family: TimesNewRomanPSMT, serif; font-size: 16px; line-height: 24px; text-align: justify;">Good Distribution Practices (GDP) </i><span style="font-family: TimesNewRomanPSMT, serif; font-size: 16px; line-height: 24px; text-align: justify;">meliputi :</span><br />
<div>
<div align="center" class="MsoListParagraphCxSpFirst" style="margin: 0in 0in 0.0001pt; text-align: center;">
<br /></div>
<div class="MsoListParagraphCxSpMiddle" style="margin-bottom: 0.0001pt; text-align: justify; text-indent: -0.25in;">
<!--[if !supportLists]--><span style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT; mso-fareast-font-family: TimesNewRomanPSMT;">1.<span style="font-family: 'Times New Roman'; font-size: 7pt;"> </span></span><!--[endif]--><span style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT;">Produk afkiran/tolakan dan produk dikembalikan ke
distributor harus di identifikasi dan ditangani dengan tepat sesuai dengan
prosedur dan disimpan pada ruang terpisah untuk menghindari tercampur aduk
dengan barang lain sampai menunggu tindakan lanjutan. Kondisi ruangan produk
afkiran/tolakan dan produk dikembalikan harus dipelihara sesuai dengan
spesifikasi penyimpanan produk. <o:p></o:p></span></div>
<div class="MsoListParagraphCxSpMiddle" style="margin-bottom: 0.0001pt; text-align: justify; text-indent: -0.25in;">
<!--[if !supportLists]--><span style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT; mso-fareast-font-family: TimesNewRomanPSMT;">2.<span style="font-family: 'Times New Roman'; font-size: 7pt;"> </span></span><!--[endif]--><span style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT;">Penilaian keperluan dan keputusan mengenai penempatan produk
harus ditentukan oleh orang yang kompeten. Karakteristik produk kembalian ke
distributor, persyaratan kondisi penyimpanan, sejarah, kondisi, dan jangka
waktu sejak terjadinya kasus, harus dicatat pada laporan penanganan. Jika ada
keraguan yang muncul mengenai mutu produk, jangan ada pertimbangan akan
menggunakan kembali produk tsb. <o:p></o:p></span></div>
<div class="MsoListParagraphCxSpMiddle" style="margin-bottom: 0.0001pt; text-align: justify; text-indent: -0.25in;">
<!--[if !supportLists]--><span style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT; mso-fareast-font-family: TimesNewRomanPSMT;">3.<span style="font-family: 'Times New Roman'; font-size: 7pt;"> </span></span><!--[endif]--><span style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT;">Harus dibuat ketentuan mengenai kesesuaian dan keamanan
pengiriman produk kembalian berdasarkan dengan penyimpanan yang sesuai dan
persyaratan lainnya.<o:p></o:p></span></div>
<div class="MsoListParagraphCxSpMiddle" style="margin-bottom: 0.0001pt; text-align: justify; text-indent: -0.25in;">
<!--[if !supportLists]--><span style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT; mso-fareast-font-family: TimesNewRomanPSMT;">4.<span style="font-family: 'Times New Roman'; font-size: 7pt;"> </span></span><!--[endif]--><span style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT;">Harus dibuat ketentuan mengenai kesesuaian dan keamanan
pengiriman bahan yang ditolak dan sampah produk sebelum produk tsb dimusnahkan.<o:p></o:p></span></div>
<div class="MsoListParagraphCxSpMiddle" style="margin-bottom: 0.0001pt; text-align: justify; text-indent: -0.25in;">
<!--[if !supportLists]--><span style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT; mso-fareast-font-family: TimesNewRomanPSMT;">5.<span style="font-family: 'Times New Roman'; font-size: 7pt;"> </span></span><!--[endif]--><span style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT;">Pemusnahan produk harus sesuai dengan aturan yang berlaku
dengan mempertimbangkan kelestarian lingkungan.<o:p></o:p></span></div>
<div class="MsoListParagraphCxSpLast" style="margin-bottom: 0.0001pt; text-align: justify; text-indent: -0.25in;">
<!--[if !supportLists]--><span style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT; mso-fareast-font-family: TimesNewRomanPSMT;">6.<span style="font-family: 'Times New Roman'; font-size: 7pt;">
</span></span><!--[endif]--><span style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT;">Semua catatan mengenai produk
kembalian, afkir/tolakan, dan pemusnahan produk harus disimpan dengan baik.<o:p></o:p></span></div>
<div class="MsoNormal" style="margin-bottom: 0.0001pt; text-align: justify;">
<br /></div>
</div>
<br />Andi Usman Pharmahttp://www.blogger.com/profile/00236524553139613509noreply@blogger.com0tag:blogger.com,1999:blog-4997010120417470107.post-80541801254510524062013-01-30T06:55:00.000-08:002013-01-30T06:55:54.582-08:00Komplain dalam CDOB<span style="font-family: TimesNewRomanPSMT, serif; font-size: 16px; line-height: 24px; text-align: justify;">Prinsip komplain dalam Cara Distribusi yang Baik (CDOB) / </span><i style="font-family: TimesNewRomanPSMT, serif; font-size: 16px; line-height: 24px; text-align: justify;">Good Distribution Practices (GDP) </i><span style="font-family: TimesNewRomanPSMT, serif; font-size: 16px; line-height: 24px; text-align: justify;">meliputi :</span><br />
<br />
<div align="center" class="MsoNormal" style="margin-bottom: 0.0001pt; text-align: center;">
<br /></div>
<div class="MsoListParagraphCxSpFirst" style="margin-bottom: 0.0001pt; text-align: justify; text-indent: -0.25in;">
<!--[if !supportLists]--><span style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT; mso-fareast-font-family: TimesNewRomanPSMT;">1.<span style="font-family: 'Times New Roman'; font-size: 7pt;">
</span></span><!--[endif]--><span style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT;">Harus ada prosedur tertulis untuk
menangani komplain. Perbedaan harus dibuat antara complain mengenai produk atau
kemasan dan hal yang berkaitan dengan
distribusi. Pada beberapa kasus complain tentang kualitas produk atau kemasan
asli dari pabrik atau pemasar yang berhak harus segera di informasikan kepada
mereka.<o:p></o:p></span></div>
<div class="MsoListParagraphCxSpMiddle" style="margin-bottom: 0.0001pt; text-align: justify; text-indent: -0.25in;">
<!--[if !supportLists]--><span style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT; mso-fareast-font-family: TimesNewRomanPSMT;">2.<span style="font-family: 'Times New Roman'; font-size: 7pt;">
</span></span><!--[endif]--><span style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT;">Semua complain dan informasi lainnya
mengenai kemungkinan cacat dan pemalsuan produk harus ditinjau ulang dengan
hati-hati berdasarkan prosedur tertulis yang menjelaskan tindakan yang harus
dilakukan, termasuk pertimbangan untuk dilakukan penarikan kembali produk.<o:p></o:p></span></div>
<div class="MsoListParagraphCxSpMiddle" style="margin-bottom: 0.0001pt; text-align: justify; text-indent: -0.25in;">
<!--[if !supportLists]--><span style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT; mso-fareast-font-family: TimesNewRomanPSMT;">3.<span style="font-family: 'Times New Roman'; font-size: 7pt;">
</span></span><!--[endif]--><span style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT;">Komplain mengenai cacat bahan harus
dicatat serta dilakukan penelusuran untuk mengidentifikasi akar masalah
complain tsb.<o:p></o:p></span></div>
<div class="MsoListParagraphCxSpMiddle" style="margin-bottom: 0.0001pt; text-align: justify; text-indent: -0.25in;">
<!--[if !supportLists]--><span style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT; mso-fareast-font-family: TimesNewRomanPSMT;">4.<span style="font-family: 'Times New Roman'; font-size: 7pt;">
</span></span><!--[endif]--><span style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT;">Jika ditemukan atau diduga cacat
berkaitan dengan isi produk perlu dipertimbangkan pengecekan produk lain dengan
no bets tsb dan bets lainnya.<o:p></o:p></span></div>
<div class="MsoListParagraphCxSpMiddle" style="margin-bottom: 0.0001pt; text-align: justify; text-indent: -0.25in;">
<!--[if !supportLists]--><span style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT; mso-fareast-font-family: TimesNewRomanPSMT;">5.<span style="font-family: 'Times New Roman'; font-size: 7pt;">
</span></span><!--[endif]--><span style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT;">Jika diperlukan harus dilakukan
tindakan lanjutan yang tepat setelah penelusuran dan evaluasi complain tsb. Hal
tsb bertujuan untuk menghindari terjadinya complain yang serupa.<o:p></o:p></span></div>
<div class="MsoListParagraphCxSpMiddle" style="margin-bottom: 0.0001pt; text-align: justify; text-indent: -0.25in;">
<!--[if !supportLists]--><span style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT; mso-fareast-font-family: TimesNewRomanPSMT;">6.<span style="font-family: 'Times New Roman'; font-size: 7pt;">
</span></span><!--[endif]--><span style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT;">Semua prosedur harus di cek berkala dan
disesuaikan dengan kondisi terkini.<o:p></o:p></span></div>
<div class="MsoListParagraphCxSpMiddle" style="margin-bottom: 0.0001pt; text-align: justify; text-indent: -0.25in;">
<!--[if !supportLists]--><span style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT; mso-fareast-font-family: TimesNewRomanPSMT;">7.<span style="font-family: 'Times New Roman'; font-size: 7pt;">
</span></span><!--[endif]--><span style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT;">Pabrik pembuat harus diinformasi
mengenai adanya penarikan kembali produk jika penarikan kembali produk atas
dasar inisiatif dari instansi lain (pemerintah, distributor). Perlu dilakukan
konsultasi kepada pabrik pembuat atau pemasar yang berwenang mengenai inisiatif
penarikan kembali produk.<o:p></o:p></span></div>
<div class="MsoListParagraphCxSpMiddle" style="margin-bottom: 0.0001pt; text-align: justify; text-indent: -0.25in;">
<!--[if !supportLists]--><span style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT; mso-fareast-font-family: TimesNewRomanPSMT;">8.<span style="font-family: 'Times New Roman'; font-size: 7pt;">
</span></span><!--[endif]--><span style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT;">Efektifitas perencanaan penarikan
kembali produk harus dievaluasi secara berkala.<o:p></o:p></span></div>
<div class="MsoListParagraphCxSpMiddle" style="margin-bottom: 0.0001pt; text-align: justify; text-indent: -0.25in;">
<!--[if !supportLists]--><span style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT; mso-fareast-font-family: TimesNewRomanPSMT;">9.<span style="font-family: 'Times New Roman'; font-size: 7pt;">
</span></span><!--[endif]--><span style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT;">Semua produk penarikan kembali harus
disimpan pada ruang yang aman, terpisah, dan diberi penandaan yang jelas selama
menunggu tindakan yang tepat.<o:p></o:p></span></div>
<div class="MsoListParagraphCxSpMiddle" style="margin-bottom: 0.0001pt; text-align: justify; text-indent: -0.25in;">
<!--[if !supportLists]--><span style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT; mso-fareast-font-family: TimesNewRomanPSMT;">10.<span style="font-family: 'Times New Roman'; font-size: 7pt;"> </span></span><!--[endif]--><span style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT;">Semua konsumen dan instansi yang berwenang disemua Negara
dimana produk tsb diedarkan harus segera diinformasi mengenai adanya penarikan
kembali produk disertai alas an yang jelas.<o:p></o:p></span></div>
<div class="MsoListParagraphCxSpMiddle" style="margin-bottom: 0.0001pt; text-align: justify; text-indent: -0.25in;">
<!--[if !supportLists]--><span style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT; mso-fareast-font-family: TimesNewRomanPSMT;">11.<span style="font-family: 'Times New Roman'; font-size: 7pt;"> </span></span><!--[endif]--><span style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT;">Semua catatan mengenai peredaran produk yang akan ditarik
kembali harus segera diberikan kepada orang yang diberi wewenang menangani
penarikan kembali produk.<o:p></o:p></span></div>
<div class="MsoListParagraphCxSpLast" style="margin-bottom: 0.0001pt; text-align: justify; text-indent: -0.25in;">
<!--[if !supportLists]--><span style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT; mso-fareast-font-family: TimesNewRomanPSMT;">12.<span style="font-family: 'Times New Roman'; font-size: 7pt;"> </span></span><!--[endif]--><span style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT;">Perkembangan proses penarikan produk harus dicatat. Hasil
akhir dilakukan dengan membandingkan antara jumlah produk yang didistribusikan
dengan jumlah produk yang diterima kembali.<o:p></o:p></span></div>
Andi Usman Pharmahttp://www.blogger.com/profile/00236524553139613509noreply@blogger.com0tag:blogger.com,1999:blog-4997010120417470107.post-88977074567674863602013-01-30T06:53:00.000-08:002013-01-30T06:53:24.994-08:00Dokumentasi dalam CDOB<span style="font-family: TimesNewRomanPSMT, serif; font-size: 16px; line-height: 24px; text-align: justify;">Prinsip dokumentasi dalam Cara Distribusi yang Baik (CDOB) / </span><i style="font-family: TimesNewRomanPSMT, serif; font-size: 16px; line-height: 24px; text-align: justify;">Good Distribution Practices (GDP) </i><span style="font-family: TimesNewRomanPSMT, serif; font-size: 16px; line-height: 24px; text-align: justify;">meliputi :</span><br />
<br />
<div class="MsoListParagraphCxSpFirst" style="margin-bottom: 0.0001pt; text-align: justify; text-indent: -0.25in;">
<!--[if !supportLists]--><span style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT; mso-fareast-font-family: TimesNewRomanPSMT;">1.<span style="font-family: 'Times New Roman'; font-size: 7pt;">
</span></span><!--[endif]--><span style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT;">Harus tersedia perintah kerja tertulis
untuk semua aktivitas yang berkaitan denganproses distribusi termasuk kriteria
penerimaan. <o:p></o:p></span></div>
<div class="MsoListParagraphCxSpMiddle" style="margin-bottom: 0.0001pt; text-align: justify; text-indent: -0.25in;">
<!--[if !supportLists]--><span style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT; mso-fareast-font-family: TimesNewRomanPSMT;">2.<span style="font-family: 'Times New Roman'; font-size: 7pt;">
</span></span><!--[endif]--><span style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT;">Prosedur harus di tetapkan dan dipelihara
untuk persiapan, peninjauan ulang, persetujuan dan kontrol perubahan semua
dokumen yang berkaitan dengan proses distribusi.<o:p></o:p></span></div>
<div class="MsoListParagraphCxSpMiddle" style="margin-bottom: 0.0001pt; text-align: justify; text-indent: -0.25in;">
<!--[if !supportLists]--><span style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT; mso-fareast-font-family: TimesNewRomanPSMT;">3.<span style="font-family: 'Times New Roman'; font-size: 7pt;">
</span></span><!--[endif]--><span style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT;">Dokumen baik perintah kerja atau
prosedur yang berkaitan dengan aktivitas yang memiliki dampak kepada mutu
produk harus didesain, dibuat, di tinjau ulang, dan didistribusikan dngan
hati-hati.<o:p></o:p></span></div>
<div class="MsoListParagraphCxSpMiddle" style="margin-bottom: 0.0001pt; text-align: justify; text-indent: -0.25in;">
<!--[if !supportLists]--><span style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT; mso-fareast-font-family: TimesNewRomanPSMT;">4.<span style="font-family: 'Times New Roman'; font-size: 7pt;">
</span></span><!--[endif]--><span style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT;">Judul, latar belakang, dan tujuan
setiap dokumen harus jelas. Isi dokumen harus jelas dan tidak ambigu. Tampilan
dokumen harus sederhana dan mudah dicek. <o:p></o:p></span></div>
<div class="MsoListParagraphCxSpMiddle" style="margin-bottom: 0.0001pt; text-align: justify; text-indent: -0.25in;">
<!--[if !supportLists]--><span style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT; mso-fareast-font-family: TimesNewRomanPSMT;">5.<span style="font-family: 'Times New Roman'; font-size: 7pt;">
</span></span><!--[endif]--><span style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT;">Semua dokumen harus lengkap, disetujui,
ditandatangani, dan diberi tanggal oleh orang yang berwenang dan tidak diubah
tanpa kebutuhan otoritas yang berwenang. <o:p></o:p></span></div>
<div class="MsoListParagraphCxSpMiddle" style="margin-bottom: 0.0001pt; text-align: justify; text-indent: -0.25in;">
<!--[if !supportLists]--><span style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT; mso-fareast-font-family: TimesNewRomanPSMT;">6.<span style="font-family: 'Times New Roman'; font-size: 7pt;">
</span></span><!--[endif]--><span style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT;">Harus memenuhi persyaratan
perundang-undangan yang berlaku.<o:p></o:p></span></div>
<div class="MsoListParagraphCxSpMiddle" style="margin-bottom: 0.0001pt; text-align: justify; text-indent: -0.25in;">
<!--[if !supportLists]--><span style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT; mso-fareast-font-family: TimesNewRomanPSMT;">7.<span style="font-family: 'Times New Roman'; font-size: 7pt;">
</span></span><!--[endif]--><span style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT;">Distributor harus menetapkan dan
memelihara prosedur untuk prosedur identifikasi, koleksi, indeks, mendapatkan
kembali, penyimpanan,pemusnahan, dan akses mendapatkan dokumen.<o:p></o:p></span></div>
<div class="MsoListParagraphCxSpMiddle" style="margin-bottom: 0.0001pt; text-align: justify; text-indent: -0.25in;">
<!--[if !supportLists]--><span style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT; mso-fareast-font-family: TimesNewRomanPSMT;">8.<span style="font-family: 'Times New Roman'; font-size: 7pt;">
</span></span><!--[endif]--><span style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT;">Semua dokumen harus disimpan pada
tempat yang aman, kondisi lingkungan yang sesuai (tidak lembab), dan terlindung
dari actor luar.<o:p></o:p></span></div>
<div class="MsoListParagraphCxSpMiddle" style="margin-bottom: 0.0001pt; text-align: justify; text-indent: -0.25in;">
<!--[if !supportLists]--><span style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT; mso-fareast-font-family: TimesNewRomanPSMT;">9.<span style="font-family: 'Times New Roman'; font-size: 7pt;">
</span></span><!--[endif]--><span style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT;">Dokumen harus ditinjau ulang dan sesuai
dengan kondisi terkini. Jika dokumen revisi harus ada sistem yang mencegah dokumen ganda yang digunakan. Dokumen
versi lama harus di cap “obsolete’/
tidak digunakan.<o:p></o:p></span></div>
<div class="MsoListParagraphCxSpMiddle" style="margin-bottom: 0.0001pt; text-align: justify; text-indent: -0.25in;">
<!--[if !supportLists]--><span style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT; mso-fareast-font-family: TimesNewRomanPSMT;">10.<span style="font-family: 'Times New Roman'; font-size: 7pt;"> </span></span><!--[endif]--><span style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT;">Catatan mengenai kondisi penyimpanan harus disimpan paling
tidak selama waktu daluwarsa ditambah 1 tahun.<o:p></o:p></span></div>
<div class="MsoListParagraphCxSpLast" style="margin-bottom: 0.0001pt; text-align: justify; text-indent: -0.25in;">
<!--[if !supportLists]--><span style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT; mso-fareast-font-family: TimesNewRomanPSMT;">11.<span style="font-family: 'Times New Roman'; font-size: 7pt;"> </span></span><!--[endif]--><span style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT;">Jika data menggunakan sistem elektronik maka harus tersedia
sistem backup data untuk menghindari kehilangan data.<o:p></o:p></span></div>
Andi Usman Pharmahttp://www.blogger.com/profile/00236524553139613509noreply@blogger.com0tag:blogger.com,1999:blog-4997010120417470107.post-15510062730516593422013-01-30T06:50:00.000-08:002013-01-30T06:50:46.442-08:00Transportasi dan produk dalam pengangkutan di CDOB<span style="font-family: TimesNewRomanPSMT, serif; font-size: 16px; line-height: 24px; text-align: justify;">Prinsip transportasi dan produk dalam pengangkutan di Cara Distribusi yang Baik (CDOB) / </span><i style="font-family: TimesNewRomanPSMT, serif; font-size: 16px; line-height: 24px; text-align: justify;">Good Distribution Practices (GDP) </i><span style="font-family: TimesNewRomanPSMT, serif; font-size: 16px; line-height: 24px; text-align: justify;">meliputi :</span><br />
<div class="MsoListParagraphCxSpFirst" style="margin-bottom: 0.0001pt; text-align: justify; text-indent: -0.25in;">
<!--[if !supportLists]--><span style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT; mso-fareast-font-family: TimesNewRomanPSMT;">1.<span style="font-family: 'Times New Roman'; font-size: 7pt;">
</span></span><!--[endif]--><span style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT;">Produk harus disimpan dan diangkut
sesuai dengan prosedur meliputi :<o:p></o:p></span></div>
<div class="MsoListParagraphCxSpMiddle" style="margin: 0in 0in 0.0001pt 1in; text-align: justify; text-indent: -0.25in;">
<!--[if !supportLists]--><span style="font-family: Symbol; font-size: 12.0pt; mso-bidi-font-family: Symbol; mso-fareast-font-family: Symbol;">·<span style="font-family: 'Times New Roman'; font-size: 7pt;">
</span></span><!--[endif]--><span style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT;">Identitas produk tidak hilang<o:p></o:p></span></div>
<div class="MsoListParagraphCxSpMiddle" style="margin: 0in 0in 0.0001pt 1in; text-align: justify; text-indent: -0.25in;">
<!--[if !supportLists]--><span style="font-family: Symbol; font-size: 12.0pt; mso-bidi-font-family: Symbol; mso-fareast-font-family: Symbol;">·<span style="font-family: 'Times New Roman'; font-size: 7pt;">
</span></span><!--[endif]--><span style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT;">Produk tidak mengkontaminasi dan
terkontaminasi produk lain<o:p></o:p></span></div>
<div class="MsoListParagraphCxSpMiddle" style="margin: 0in 0in 0.0001pt 1in; text-align: justify; text-indent: -0.25in;">
<!--[if !supportLists]--><span style="font-family: Symbol; font-size: 12.0pt; mso-bidi-font-family: Symbol; mso-fareast-font-family: Symbol;">·<span style="font-family: 'Times New Roman'; font-size: 7pt;">
</span></span><!--[endif]--><span style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT;">Tindakan pencegahan terhadap kerusakan,
penggelapan, dan pencurian produk.<o:p></o:p></span></div>
<div class="MsoListParagraphCxSpMiddle" style="margin: 0in 0in 0.0001pt 1in; text-align: justify; text-indent: -0.25in;">
<!--[if !supportLists]--><span style="font-family: Symbol; font-size: 12.0pt; mso-bidi-font-family: Symbol; mso-fareast-font-family: Symbol;">·<span style="font-family: 'Times New Roman'; font-size: 7pt;">
</span></span><!--[endif]--><span style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT;">Kondisi suhu dan kelembaban yang tepat
dan terpelihara<o:p></o:p></span></div>
<div class="MsoListParagraphCxSpMiddle" style="margin-bottom: 0.0001pt; text-align: justify; text-indent: -0.25in;">
<!--[if !supportLists]--><span style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT; mso-fareast-font-family: TimesNewRomanPSMT;">2.<span style="font-family: 'Times New Roman'; font-size: 7pt;">
</span></span><!--[endif]--><span style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT;">Persyaratan kondisi penyimpanan
terpelihara selama pengangkutan. Jika terjadi penyimpangan dari spesifikasi
yang ditetapkan harus dikonsultasikan ke pihak marketing dan atau pabrik yang
bersangkutan.<o:p></o:p></span></div>
<div class="MsoListParagraphCxSpMiddle" style="margin-bottom: 0.0001pt; text-align: justify; text-indent: -0.25in;">
<!--[if !supportLists]--><span style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT; mso-fareast-font-family: TimesNewRomanPSMT;">3.<span style="font-family: 'Times New Roman'; font-size: 7pt;">
</span></span><!--[endif]--><span style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT;">Proses pengangkutan harus tidak
berdampak buruk terhadao mutu dari produk.<o:p></o:p></span></div>
<div class="MsoListParagraphCxSpMiddle" style="margin-bottom: 0.0001pt; text-align: justify; text-indent: -0.25in;">
<!--[if !supportLists]--><span style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT; mso-fareast-font-family: TimesNewRomanPSMT;">4.<span style="font-family: 'Times New Roman'; font-size: 7pt;">
</span></span><!--[endif]--><span style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT;">Harus terdapat prosedur tertulis untuk
menelusuri dan memberikan solusi terhadap penyimpangan yang terjadi terhadap persyaratan
kondisi penyimpanan.<o:p></o:p></span></div>
<div class="MsoListParagraphCxSpMiddle" style="margin-bottom: 0.0001pt; text-align: justify; text-indent: -0.25in;">
<!--[if !supportLists]--><span style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT; mso-fareast-font-family: TimesNewRomanPSMT;">5.<span style="font-family: 'Times New Roman'; font-size: 7pt;">
</span></span><!--[endif]--><span style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT;">Produk berbahaya, narkotika dan
prekusor, radioaktif, mudah meledak harus menggunakan transportasi khusus aman
dan mematuhi peraturan yang berlaku.<o:p></o:p></span></div>
<div class="MsoListParagraphCxSpMiddle" style="margin-bottom: 0.0001pt; text-align: justify; text-indent: -0.25in;">
<!--[if !supportLists]--><span style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT; mso-fareast-font-family: TimesNewRomanPSMT;">6.<span style="font-family: 'Times New Roman'; font-size: 7pt;">
</span></span><!--[endif]--><span style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT;">Bagian dalam kendaraan dan kemasan
harus senantiasa bersih dan kering.<o:p></o:p></span></div>
<div class="MsoListParagraphCxSpMiddle" style="margin-bottom: 0.0001pt; text-align: justify; text-indent: -0.25in;">
<!--[if !supportLists]--><span style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT; mso-fareast-font-family: TimesNewRomanPSMT;">7.<span style="font-family: 'Times New Roman'; font-size: 7pt;">
</span></span><!--[endif]--><span style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT;">Kemasan produk dan kemasan pengangkutan
harus sesuia untuk menghindari kerusakan produk.<o:p></o:p></span></div>
<div class="MsoListParagraphCxSpMiddle" style="margin-bottom: 0.0001pt; text-align: justify; text-indent: -0.25in;">
<!--[if !supportLists]--><span style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT; mso-fareast-font-family: TimesNewRomanPSMT;">8.<span style="font-family: 'Times New Roman'; font-size: 7pt;">
</span></span><!--[endif]--><span style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT;">Keamanan yang cukup untu mencegah
terjadinya penggelapan produk.<o:p></o:p></span></div>
<div class="MsoListParagraphCxSpMiddle" style="margin-bottom: 0.0001pt; text-align: justify; text-indent: -0.25in;">
<!--[if !supportLists]--><span style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT; mso-fareast-font-family: TimesNewRomanPSMT;">9.<span style="font-family: 'Times New Roman'; font-size: 7pt;">
</span></span><!--[endif]--><span style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT;">Harus memperhatikan keamanan,
kesehatan, dan ramah lingkungan.<o:p></o:p></span></div>
<div class="MsoListParagraphCxSpMiddle" style="margin-bottom: 0.0001pt; text-align: justify; text-indent: -0.25in;">
<!--[if !supportLists]--><span style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT; mso-fareast-font-family: TimesNewRomanPSMT;">10.<span style="font-family: 'Times New Roman'; font-size: 7pt;"> </span></span><!--[endif]--><span style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT;">Kerusakan produk yang terjadi selama proses pengangkutan
harus dicatat dan dilaporkan ke bagian terkait yang berwenang dan dilakukan
penulusuran untuk mengetahui penyebab kerusakan.<o:p></o:p></span></div>
<div class="MsoListParagraphCxSpMiddle" style="margin-bottom: 0.0001pt; text-align: justify; text-indent: -0.25in;">
<!--[if !supportLists]--><span style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT; mso-fareast-font-family: TimesNewRomanPSMT;">11.<span style="font-family: 'Times New Roman'; font-size: 7pt;"> </span></span><!--[endif]--><span style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT;">Sistem penelusuran no bets harus digunakan supaya dapat
dilakukan penulusuran selama transportasi.<o:p></o:p></span></div>
<div class="MsoListParagraphCxSpLast" style="margin-bottom: 0.0001pt; text-align: justify; text-indent: -0.25in;">
<!--[if !supportLists]--><span style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT; mso-fareast-font-family: TimesNewRomanPSMT;">12.<span style="font-family: 'Times New Roman'; font-size: 7pt;"> </span></span><!--[endif]--><span style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT;">Produk dalam masa singgah harus disertai dokumentasi yang
tepat.<o:p></o:p></span></div>
Andi Usman Pharmahttp://www.blogger.com/profile/00236524553139613509noreply@blogger.com1tag:blogger.com,1999:blog-4997010120417470107.post-50461546360318316252013-01-30T06:33:00.001-08:002013-01-30T06:47:54.093-08:00Pengiriman dalam CDOB<span style="font-family: TimesNewRomanPSMT, serif; font-size: 16px; line-height: 24px; text-align: justify;">Prinsip pengiriman dalam Cara Distribusi yang Baik (CDOB) / </span><i style="font-family: TimesNewRomanPSMT, serif; font-size: 16px; line-height: 24px; text-align: justify;">Good Distribution Practices (GDP) </i><span style="font-family: TimesNewRomanPSMT, serif; font-size: 16px; line-height: 24px; text-align: justify;">meliputi :</span><br />
<div class="MsoListParagraphCxSpMiddle" style="margin-bottom: 0.0001pt; text-align: justify; text-indent: -0.25in;">
<!--[if !supportLists]--><span style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT; mso-fareast-font-family: TimesNewRomanPSMT;">1.<span style="font-family: 'Times New Roman'; font-size: 7pt;">
</span></span><!--[endif]--><span style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT;">Produk hanya dijual dan distribusikan
ke lembaga atau instansi yang memiliki ijin dan legalitas dari pemerintah. Bukti
tertulis mengenai legalitas lembaga atau instansi harus diperoleh terlebih
dahulu seblum produk dikirim. <o:p></o:p></span></div>
<div class="MsoListParagraphCxSpMiddle" style="margin-bottom: 0.0001pt; text-align: justify; text-indent: -0.25in;">
<!--[if !supportLists]--><span style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT; mso-fareast-font-family: TimesNewRomanPSMT;">2.<span style="font-family: 'Times New Roman'; font-size: 7pt;">
</span></span><!--[endif]--><span style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT;">Penyalur produk harus menjamin bahwa
orang dan bagian terkait memiliki transportasi dan penyimpanan yang memenuhi
syarat sebelum produk dikirimkan.<o:p></o:p></span></div>
<div class="MsoListParagraphCxSpMiddle" style="margin-bottom: 0.0001pt; text-align: justify; text-indent: -0.25in;">
<!--[if !supportLists]--><span style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT; mso-fareast-font-family: TimesNewRomanPSMT;">3.<span style="font-family: 'Times New Roman'; font-size: 7pt;">
</span></span><!--[endif]--><span style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT;">Pengimiman dan pengangkutan produk
dilakukan setelah pesanan pengiriman sah atau rencana pengiriman barang
sudah terdokumenatasi.<o:p></o:p></span></div>
<div class="MsoListParagraphCxSpMiddle" style="margin-bottom: 0.0001pt; text-align: justify; text-indent: -0.25in;">
<!--[if !supportLists]--><span style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT; mso-fareast-font-family: TimesNewRomanPSMT;">4.<span style="font-family: 'Times New Roman'; font-size: 7pt;">
</span></span><!--[endif]--><span style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT;">Prosedur tertulis mengenai pengiriman
produk harus ditetapkan. Prosedur dibuat berdasarkan sifat dan karakteristik
produk serta tindakan pencegahan yang telah dikaji. <o:p></o:p></span></div>
<div class="MsoListParagraphCxSpMiddle" style="margin-bottom: 0.0001pt; text-align: justify; text-indent: -0.25in;">
<!--[if !supportLists]--><span style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT; mso-fareast-font-family: TimesNewRomanPSMT;">5.<span style="font-family: 'Times New Roman'; font-size: 7pt;">
</span></span><!--[endif]--><span style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT;">Catatan untuk pengiriman produk harus
disiapkan dan mengandung informasi
meliputi :<o:p></o:p></span></div>
<div class="MsoListParagraphCxSpMiddle" style="margin: 0in 0in 0.0001pt 1in; text-align: justify; text-indent: -0.25in;">
<!--[if !supportLists]--><span style="font-family: Symbol; font-size: 12.0pt; mso-bidi-font-family: Symbol; mso-fareast-font-family: Symbol;">·<span style="font-family: 'Times New Roman'; font-size: 7pt;">
</span></span><!--[endif]--><span style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT;">Tanggal pengiriman.<o:p></o:p></span></div>
<div class="MsoListParagraphCxSpMiddle" style="margin: 0in 0in 0.0001pt 1in; text-align: justify; text-indent: -0.25in;">
<!--[if !supportLists]--><span style="font-family: Symbol; font-size: 12.0pt; mso-bidi-font-family: Symbol; mso-fareast-font-family: Symbol;">·<span style="font-family: 'Times New Roman'; font-size: 7pt;">
</span></span><!--[endif]--><span style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT;">Nama dan alamat instansi yang
bertangunggjawab terhadap pengangkutan.<o:p></o:p></span></div>
<div class="MsoListParagraphCxSpMiddle" style="margin: 0in 0in 0.0001pt 1in; text-align: justify; text-indent: -0.25in;">
<!--[if !supportLists]--><span style="font-family: Symbol; font-size: 12.0pt; mso-bidi-font-family: Symbol; mso-fareast-font-family: Symbol;">·<span style="font-family: 'Times New Roman'; font-size: 7pt;">
</span></span><!--[endif]--><span style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT;">Nama, alamat, dan status instansi yang
dituju<o:p></o:p></span></div>
<div class="MsoListParagraphCxSpMiddle" style="margin: 0in 0in 0.0001pt 1in; text-align: justify; text-indent: -0.25in;">
<!--[if !supportLists]--><span style="font-family: Symbol; font-size: 12.0pt; mso-bidi-font-family: Symbol; mso-fareast-font-family: Symbol;">·<span style="font-family: 'Times New Roman'; font-size: 7pt;">
</span></span><!--[endif]--><span style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT;">Deskripsi produk (nama, bentuk sediaan,
dosis, dll)<o:p></o:p></span></div>
<div class="MsoListParagraphCxSpMiddle" style="margin: 0in 0in 0.0001pt 1in; text-align: justify; text-indent: -0.25in;">
<!--[if !supportLists]--><span style="font-family: Symbol; font-size: 12.0pt; mso-bidi-font-family: Symbol; mso-fareast-font-family: Symbol;">·<span style="font-family: 'Times New Roman'; font-size: 7pt;">
</span></span><!--[endif]--><span style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT;">Jumlah produk yang dikirim<o:p></o:p></span></div>
<div class="MsoListParagraphCxSpMiddle" style="margin: 0in 0in 0.0001pt 1in; text-align: justify; text-indent: -0.25in;">
<!--[if !supportLists]--><span style="font-family: Symbol; font-size: 12.0pt; mso-bidi-font-family: Symbol; mso-fareast-font-family: Symbol;">·<span style="font-family: 'Times New Roman'; font-size: 7pt;">
</span></span><!--[endif]--><span style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT;">No bets dan tanggal daluwarsa<o:p></o:p></span></div>
<div class="MsoListParagraphCxSpMiddle" style="margin: 0in 0in 0.0001pt 1in; text-align: justify; text-indent: -0.25in;">
<!--[if !supportLists]--><span style="font-family: Symbol; font-size: 12.0pt; mso-bidi-font-family: Symbol; mso-fareast-font-family: Symbol;">·<span style="font-family: 'Times New Roman'; font-size: 7pt;">
</span></span><!--[endif]--><span style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT;">Jenis pengangkutan dan kondisi
penyimpanan yang dapat digunakan<o:p></o:p></span></div>
<div class="MsoListParagraphCxSpMiddle" style="margin-bottom: 0.0001pt; text-align: justify; text-indent: -0.25in;">
<!--[if !supportLists]--><span style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT; mso-fareast-font-family: TimesNewRomanPSMT;">6.<span style="font-family: 'Times New Roman'; font-size: 7pt;">
</span></span><!--[endif]--><span style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT;">Catatan pengiriman harus mengandung
informasu yang dapat digunakan untuk penulusuran kembali produk yang telah
dikirim.<o:p></o:p></span></div>
<div class="MsoListParagraphCxSpMiddle" style="margin-bottom: 0.0001pt; text-align: justify; text-indent: -0.25in;">
<!--[if !supportLists]--><span style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT; mso-fareast-font-family: TimesNewRomanPSMT;">7.<span style="font-family: 'Times New Roman'; font-size: 7pt;">
</span></span><!--[endif]--><span style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT;">Cara pengangkutan meliputi kendaraan
yang digunakan harus dipilih dengan tepat, perlu dipertimbangan kondisi
lingkungan. Pengiriman produk mempersyaratkan pengendalian suhu sesuai dengan
kondisi penyimpanan.<o:p></o:p></span></div>
<div class="MsoListParagraphCxSpMiddle" style="margin-bottom: 0.0001pt; text-align: justify; text-indent: -0.25in;">
<!--[if !supportLists]--><span style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT; mso-fareast-font-family: TimesNewRomanPSMT;">8.<span style="font-family: 'Times New Roman'; font-size: 7pt;">
</span></span><!--[endif]--><span style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT;">Jadwal dan rute pengiriman harus
ditetapkan. Jadwal dan rencana harus realistis dan sistematis. Jumlah produk
yang dikirim harus memperhatikan kapasitas dan fasilitas penyimapnan alamat
yang dituju.<o:p></o:p></span></div>
<div class="MsoListParagraphCxSpMiddle" style="margin-bottom: 0.0001pt; text-align: justify; text-indent: -0.25in;">
<!--[if !supportLists]--><span style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT; mso-fareast-font-family: TimesNewRomanPSMT;">9.<span style="font-family: 'Times New Roman'; font-size: 7pt;">
</span></span><!--[endif]--><span style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT;">Jika dapat diterapkan pengisian barang
ke kendaraan dibuat sisematis dan hati-hati. Produk yang pertama keluar
diletakkan pada bagian paling luar. Berhati-hati pada saat bongkar muat barang
untuk menghindari karton rusak.<o:p></o:p></span></div>
<div class="MsoListParagraphCxSpLast" style="margin-bottom: 0.0001pt; text-align: justify; text-indent: -0.25in;">
<!--[if !supportLists]--><span style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT; mso-fareast-font-family: TimesNewRomanPSMT;">10.<span style="font-family: 'Times New Roman'; font-size: 7pt;"> </span></span><!--[endif]--><span style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT;">Barang yang dikirim dan diterima tidak boleh melewati maupun
mendekati waktu daluwarsa untuk menghindari produk dikonsumsi oleh konsumen.<o:p></o:p></span></div>
Andi Usman Pharmahttp://www.blogger.com/profile/00236524553139613509noreply@blogger.com0tag:blogger.com,1999:blog-4997010120417470107.post-34015186963320674272013-01-29T06:30:00.001-08:002013-01-30T06:31:43.166-08:00Kemasan dan Penandaan kemasan dalam CDOB<br />
<div class="MsoNormal" style="margin-bottom: 0.0001pt; text-align: left;">
<span style="background-color: #d0e0e3;"><span style="font-family: TimesNewRomanPSMT, serif; font-size: 16px; line-height: 24px; text-align: justify;">Prinsip kemasan dan penandaan kemasan dalam Cara Distribusi yang Baik (CDOB) / </span><i style="font-family: TimesNewRomanPSMT, serif; font-size: 16px; line-height: 24px; text-align: justify;">Good Distribution Practices (GDP) </i><span style="font-family: TimesNewRomanPSMT, serif; font-size: 16px; line-height: 24px; text-align: justify;">meliputi :</span></span></div>
<div class="MsoListParagraphCxSpFirst" style="margin: 0cm 0cm 0.0001pt 40.5pt; text-align: justify; text-indent: -18pt;">
<!--[if !supportLists]--><span lang="EN-US" style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT; mso-fareast-font-family: TimesNewRomanPSMT;">1.<span style="font-family: 'Times New Roman'; font-size: 7pt;">
</span></span><!--[endif]--><span lang="EN-US" style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT;">Semua
produk harus disimpan dan didistribusikan dalam kemasan yang tidak memiliki
efek samping terhadap mutu produk dan mampu melindungi dengan baik dari
pengaruh luar termasuk kontaminasi mikroba. <o:p></o:p></span></div>
<div class="MsoListParagraphCxSpMiddle" style="margin: 0cm 0cm 0.0001pt 40.5pt; text-align: justify; text-indent: -18pt;">
<!--[if !supportLists]--><span lang="EN-US" style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT; mso-fareast-font-family: TimesNewRomanPSMT;">2.<span style="font-family: 'Times New Roman'; font-size: 7pt;">
</span></span><!--[endif]--><span lang="EN-US" style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT;">Kemasan
pengiriman tidak perlu mengandung semua penandaan dengan deskripsi penuh dari
isi dalam kemasan tetapi setidaknya harus terdapat informasi mengenai cara
penanganan dan kondisi penyimpanan serta
tindakan pencegahan untuk menjamin produk ditangani dengan tepat.<o:p></o:p></span></div>
<div class="MsoListParagraphCxSpMiddle" style="margin: 0cm 0cm 0.0001pt 40.5pt; text-align: justify; text-indent: -18pt;">
<!--[if !supportLists]--><span lang="EN-US" style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT; mso-fareast-font-family: TimesNewRomanPSMT;">3.<span style="font-family: 'Times New Roman'; font-size: 7pt;">
</span></span><!--[endif]--><span lang="EN-US" style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT;">Pengiriman
dan kondisi penyimpanan khusus harus terdapat penandaan. Jika produk dikirim ke
luar dari pengawasan dari sistem pabrik maka dipersyaratkan tertera nama dan
alamat pabrik, kondisi penyimpanan khusus, dan sesuatu yang berkaitan dengan
perundang-undangan.<o:p></o:p></span></div>
<div class="MsoListParagraphCxSpMiddle" style="margin: 0cm 0cm 0.0001pt 40.5pt; text-align: justify; text-indent: -18pt;">
<!--[if !supportLists]--><span lang="EN-US" style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT; mso-fareast-font-family: TimesNewRomanPSMT;">4.<span style="font-family: 'Times New Roman'; font-size: 7pt;">
</span></span><!--[endif]--><span lang="EN-US" style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT;">Penanganan
khusus harus dilakukan jika menggunakan kemasan es beku, produk jangan kontak
langsung dengan es beku karena memiliki efek samping terhadap mutu produk.<o:p></o:p></span></div>
<div class="MsoListParagraphCxSpLast" style="margin: 0cm 0cm 0.0001pt 40.5pt; text-align: justify; text-indent: -18pt;">
<!--[if !supportLists]--><span lang="EN-US" style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT; mso-fareast-font-family: TimesNewRomanPSMT;">5.<span style="font-family: 'Times New Roman'; font-size: 7pt;">
</span></span><!--[endif]--><span lang="EN-US" style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT;">Prosedur
tertulis harus tersedia untuk penanganan kemasan yang rusak. Perhatian harus
diberikan untuk produk yang memiliki potensi toksik dan bahaya. <o:p></o:p></span></div>
Andi Usman Pharmahttp://www.blogger.com/profile/00236524553139613509noreply@blogger.com0tag:blogger.com,1999:blog-4997010120417470107.post-80489402900447702252013-01-29T06:27:00.001-08:002013-01-29T06:33:47.263-08:00Kendaraan dan peralatan dalam CDOB<br />
<div class="MsoListParagraphCxSpFirst" style="margin-bottom: 0.0001pt; text-align: justify;">
<span style="background-color: #cfe2f3;"><span style="color: #232323; font-family: TimesNewRomanPSMT, serif; font-size: 16px; line-height: 24px;">Prinsip kendaraan dan peralatan dalam Cara Distribusi yang Baik (CDOB) / </span><i style="color: #232323; font-family: TimesNewRomanPSMT, serif; font-size: 16px; line-height: 24px;">Good Distribution Practices (GDP) </i><span style="color: #232323; font-family: TimesNewRomanPSMT, serif; font-size: 16px; line-height: 24px;">meliputi :</span></span></div>
<div class="MsoListParagraphCxSpMiddle" style="margin-bottom: 0.0001pt; text-align: justify;">
<br /></div>
<div class="MsoListParagraphCxSpMiddle" style="margin-bottom: 0.0001pt; text-align: justify; text-indent: -18pt;">
<!--[if !supportLists]--><span lang="EN-US" style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT; mso-fareast-font-family: TimesNewRomanPSMT;">1.<span style="font-family: 'Times New Roman'; font-size: 7pt;">
</span></span><!--[endif]--><span lang="EN-US" style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT;">Kendaraan
dan peralatan yang digunakan untuk proses distribusi, penyimpanan, dan
penanganan produk harus sesuai dengan kegunaannya dan mampu melindungi produk
dari paparan dan kontaminan yang dapat berpengaruh pada mutu produk.<o:p></o:p></span></div>
<div class="MsoListParagraphCxSpMiddle" style="margin-bottom: 0.0001pt; text-align: justify; text-indent: -18pt;">
<!--[if !supportLists]--><span lang="EN-US" style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT; mso-fareast-font-family: TimesNewRomanPSMT;">2.<span style="font-family: 'Times New Roman'; font-size: 7pt;">
</span></span><!--[endif]--><span lang="EN-US" style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT;">Desain
dan kegunaan kendaraan dan peralatan harus mampu meminimalisir kesalahan, mudah
dibersihkan dan dirawat.<o:p></o:p></span></div>
<div class="MsoListParagraphCxSpMiddle" style="margin-bottom: 0.0001pt; text-align: justify; text-indent: -18pt;">
<!--[if !supportLists]--><span lang="EN-US" style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT; mso-fareast-font-family: TimesNewRomanPSMT;">3.<span style="font-family: 'Times New Roman'; font-size: 7pt;">
</span></span><!--[endif]--><span lang="EN-US" style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT;">Jika
memungkinkan gunakan kendaraan dan peralatan yang khusus untuk setiap produk.
Jika tidak menggunakan kendaraan dan perlatan yang khusus untuk tiap produk
maka harus ada prosedur yang mengatur untuk menjaga kualitas produk terutama
mengenai pembersihan dan dokumentasi.<o:p></o:p></span></div>
<div class="MsoListParagraphCxSpMiddle" style="margin-bottom: 0.0001pt; text-align: justify; text-indent: -18pt;">
<!--[if !supportLists]--><span lang="EN-US" style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT; mso-fareast-font-family: TimesNewRomanPSMT;">4.<span style="font-family: 'Times New Roman'; font-size: 7pt;">
</span></span><!--[endif]--><span lang="EN-US" style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT;">Kendaraan
dan peralatan yang rusak harus dipisahkan dan diberi penandaan yang jelas.<o:p></o:p></span></div>
<div class="MsoListParagraphCxSpMiddle" style="margin-bottom: 0.0001pt; text-align: justify; text-indent: -18pt;">
<!--[if !supportLists]--><span lang="EN-US" style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT; mso-fareast-font-family: TimesNewRomanPSMT;">5.<span style="font-family: 'Times New Roman'; font-size: 7pt;">
</span></span><!--[endif]--><span lang="EN-US" style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT;">Harus
ada prosedur cara pengoperasian dan perawatan kendaraan dan peralatan serta
pembersihan dan peringatan keamanan.<o:p></o:p></span></div>
<div class="MsoListParagraphCxSpMiddle" style="margin-bottom: 0.0001pt; text-align: justify; text-indent: -18pt;">
<!--[if !supportLists]--><span lang="EN-US" style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT; mso-fareast-font-family: TimesNewRomanPSMT;">6.<span style="font-family: 'Times New Roman'; font-size: 7pt;">
</span></span><!--[endif]--><span lang="EN-US" style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT;">Kendaraan,
kemasan, dan peralatan harus dijaga kebersihannya, kering, dan bebas dari
kumpulan debu atau kotoran. Harus ada prosedur tertulis mengenai pembersihan
yang mencakup cara pembersihan dan jangka waktu pembersihan.<o:p></o:p></span></div>
<div class="MsoListParagraphCxSpMiddle" style="margin-bottom: 0.0001pt; text-align: justify; text-indent: -18pt;">
<!--[if !supportLists]--><span lang="EN-US" style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT; mso-fareast-font-family: TimesNewRomanPSMT;">7.<span style="font-family: 'Times New Roman'; font-size: 7pt;">
</span></span><!--[endif]--><span lang="EN-US" style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT;">Kendaraan,
kemasan, dan peralatan harus dijaga dari binatang pengerat, serangga, hama, dan
burung. Harus terdapat prosedur tertulis mengenai pengendalian hama, dll. Bahan
pembersih dan pembunuh bakteri harus aman dan tidak berdampak pada mutu produk.<o:p></o:p></span></div>
<div class="MsoListParagraphCxSpMiddle" style="margin-bottom: 0.0001pt; text-align: justify; text-indent: -18pt;">
<!--[if !supportLists]--><span lang="EN-US" style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT; mso-fareast-font-family: TimesNewRomanPSMT;">8.<span style="font-family: 'Times New Roman'; font-size: 7pt;">
</span></span><!--[endif]--><span lang="EN-US" style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT;">Peralatan
yang digunakan untuk pembersihan kendaraan harus tidak menimbulkan kontaminasi.<o:p></o:p></span></div>
<div class="MsoListParagraphCxSpMiddle" style="margin-bottom: 0.0001pt; text-align: justify; text-indent: -18pt;">
<!--[if !supportLists]--><span lang="EN-US" style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT; mso-fareast-font-family: TimesNewRomanPSMT;">9.<span style="font-family: 'Times New Roman'; font-size: 7pt;">
</span></span><!--[endif]--><span lang="EN-US" style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT;">Perhatian
khusus harus diberikan untuk cara, penggunaan, pembersihan, dan perawatan semua
peralatan yang digunakan untuk menangani produk yang tidak dikemas dengan peti
atau pelindung.<o:p></o:p></span></div>
<div class="MsoListParagraphCxSpMiddle" style="margin-bottom: 0.0001pt; text-align: justify; text-indent: -18pt;">
<!--[if !supportLists]--><span lang="EN-US" style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT; mso-fareast-font-family: TimesNewRomanPSMT;">10.<span style="font-family: 'Times New Roman'; font-size: 7pt;"> </span></span><!--[endif]--><span lang="EN-US" style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT;">Produk yang memiliki kondisi
penyimpanan khusus (suhu dan atau kelembaban) yang berbeda dengan kondisi
lingkungan luar harus tersedia kemasan khusus yang mampu menjaga kondisi
penyimpanan sesuai dengan persyaratannya. Selama pengiriman harus ada
pengecekan, monitoring, dan pencatatan kondisi penyimpanan (suhu dan atau
kelembaban). Semua catatan monitoring harus disimpan minimal waktu daluwarsa
plus 1 tahun atau sesuai dengan ketentuan yang berlaku. Pastikan semua catatan
monitoring kondisi penyimpanan memenuhi spesifikasi yang ditetapkan.<o:p></o:p></span></div>
<div class="MsoListParagraphCxSpMiddle" style="margin-bottom: 0.0001pt; text-align: justify; text-indent: -18pt;">
<!--[if !supportLists]--><span lang="EN-US" style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT; mso-fareast-font-family: TimesNewRomanPSMT;">11.<span style="font-family: 'Times New Roman'; font-size: 7pt;"> </span></span><!--[endif]--><span lang="EN-US" style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT;">Peralatan yang digunakan untuk
monitoring suhu dan aatau kelembaban kemasan dan kendaraan harus terkalibrasi.<o:p></o:p></span></div>
<div class="MsoListParagraphCxSpLast" style="margin-bottom: 0.0001pt; text-align: justify; text-indent: -18pt;">
<!--[if !supportLists]--><span lang="EN-US" style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT; mso-fareast-font-family: TimesNewRomanPSMT;">12.<span style="font-family: 'Times New Roman'; font-size: 7pt;"> </span></span><!--[endif]--><span lang="EN-US" style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT;">Kendaraan dan kemasan harus memiliki
kapasitas yang cukup untuk menyimpan produk.<o:p></o:p></span></div>
Andi Usman Pharmahttp://www.blogger.com/profile/00236524553139613509noreply@blogger.com0tag:blogger.com,1999:blog-4997010120417470107.post-52113971157356017472013-01-29T02:54:00.000-08:002013-01-29T02:54:40.820-08:00Bangunan, gudang, dan area penyimpanan dalam CDOB<br />
<div class="MsoListParagraph" style="margin-bottom: 0.0001pt; text-align: justify;">
<span lang="EN-US" style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT;">Prinsip bangunan, gudang, dan area penyimpanan dalam Cara Distribusi yang Baik (CDOB) / <i>Good Distribution Practices (GDP) </i>meliputi :<o:p></o:p></span></div>
<div align="center" class="MsoNormal" style="margin-bottom: 0.0001pt; text-align: center;">
<br /></div>
<div class="MsoListParagraphCxSpFirst" style="margin-bottom: 0.0001pt; text-align: justify; text-indent: -18pt;">
<!--[if !supportLists]--><span lang="EN-US" style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT; mso-fareast-font-family: TimesNewRomanPSMT;">1.<span style="font-family: 'Times New Roman'; font-size: 7pt;">
</span></span><!--[endif]--><span lang="EN-US" style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT;">Harus
ada peringatan yang dipajang untuk menghindari orang yang tidak memiliki hak
masuk ke ruang penyimpanan.<o:p></o:p></span></div>
<div class="MsoListParagraphCxSpMiddle" style="margin-bottom: 0.0001pt; text-align: justify; text-indent: -18pt;">
<!--[if !supportLists]--><span lang="EN-US" style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT; mso-fareast-font-family: TimesNewRomanPSMT;">2.<span style="font-family: 'Times New Roman'; font-size: 7pt;">
</span></span><!--[endif]--><span lang="EN-US" style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT;">Area
penyimpanan harus memiliki kapasitas yang cukup dan terpisah-pisah untuk produk
jadi, karantina, afkir atau <i>reject</i>,
produk kembalian, dan produk penarikan kembali.<o:p></o:p></span></div>
<div class="MsoListParagraphCxSpMiddle" style="margin-bottom: 0.0001pt; text-align: justify; text-indent: -18pt;">
<!--[if !supportLists]--><span lang="EN-US" style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT; mso-fareast-font-family: TimesNewRomanPSMT;">3.<span style="font-family: 'Times New Roman'; font-size: 7pt;">
</span></span><!--[endif]--><span lang="EN-US" style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT;">Area
penyimpanan harus didesain untuk menjamin kondisi penyimpanan yang baik.
Ruangan harus berih dan kering dan terpelihara suhunya (tidak keluar dari
spesifikasi suhu yang ditetapkan). Untuk kondisi penyimapanan khusus harus
dibei penandaan (misal suhu dan kelembaban) dan harus di cek, dimonitoring, dan
dicatat. Produk harus diletakkan diatas lantai menggunakan palet yang memiliki
rongga yang mudah dibersihkan.Palet harus dijaga dalam kondisi yang baik dan
bersih. <o:p></o:p></span></div>
<div class="MsoListParagraphCxSpMiddle" style="margin-bottom: 0.0001pt; text-align: justify; text-indent: -18pt;">
<!--[if !supportLists]--><span lang="EN-US" style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT; mso-fareast-font-family: TimesNewRomanPSMT;">4.<span style="font-family: 'Times New Roman'; font-size: 7pt;">
</span></span><!--[endif]--><span lang="EN-US" style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT;">Area
penyimpanan harus bersih dan bebas dari kumpulan kotoran dan serangga.<o:p></o:p></span></div>
<div class="MsoListParagraphCxSpMiddle" style="margin-bottom: 0.0001pt; text-align: justify; text-indent: -18pt;">
<!--[if !supportLists]--><span lang="EN-US" style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT; mso-fareast-font-family: TimesNewRomanPSMT;">5.<span style="font-family: 'Times New Roman'; font-size: 7pt;">
</span></span><!--[endif]--><span lang="EN-US" style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT;">Prosedur
pembersihan harus tersedia yang mencakup frekuensiatau jadwal pembersihan dan
cara pembersihan bangunan dan area penyimpanan.<o:p></o:p></span></div>
<div class="MsoListParagraphCxSpMiddle" style="margin-bottom: 0.0001pt; text-align: justify; text-indent: -18pt;">
<!--[if !supportLists]--><span lang="EN-US" style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT; mso-fareast-font-family: TimesNewRomanPSMT;">6.<span style="font-family: 'Times New Roman'; font-size: 7pt;">
</span></span><!--[endif]--><span lang="EN-US" style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT;">Harus
tersedia prosedur pengendalian hama atau binantang pengerat. Material pengendali
hama harus aman dan tidak mengkontaminasi produk.<o:p></o:p></span></div>
<div class="MsoListParagraphCxSpMiddle" style="margin-bottom: 0.0001pt; text-align: justify; text-indent: -18pt;">
<!--[if !supportLists]--><span lang="EN-US" style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT; mso-fareast-font-family: TimesNewRomanPSMT;">7.<span style="font-family: 'Times New Roman'; font-size: 7pt;">
</span></span><!--[endif]--><span lang="EN-US" style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT;">Produk
yang berbahaya, radioaktif, narkotik, mudah terbakar harus disimpan pada ruang
khusus yang dilengkapi alat pengaman.<o:p></o:p></span></div>
<div class="MsoListParagraphCxSpMiddle" style="margin-bottom: 0.0001pt; text-align: justify; text-indent: -18pt;">
<!--[if !supportLists]--><span lang="EN-US" style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT; mso-fareast-font-family: TimesNewRomanPSMT;">8.<span style="font-family: 'Times New Roman'; font-size: 7pt;">
</span></span><!--[endif]--><span lang="EN-US" style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT;">Sistem
distibrusi menggunakan system FEFO (<i>First
expred First Out</i>) dan FIFO (<i>First In
first out</i>).<o:p></o:p></span></div>
<div class="MsoListParagraphCxSpMiddle" style="margin-bottom: 0.0001pt; text-align: justify; text-indent: -18pt;">
<!--[if !supportLists]--><span lang="EN-US" style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT; mso-fareast-font-family: TimesNewRomanPSMT;">9.<span style="font-family: 'Times New Roman'; font-size: 7pt;">
</span></span><!--[endif]--><span lang="EN-US" style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT;">Harus
memiliki penerangan yang cukup.<o:p></o:p></span></div>
<div class="MsoListParagraphCxSpMiddle" style="margin-bottom: 0.0001pt; text-align: justify; text-indent: -18pt;">
<!--[if !supportLists]--><span lang="EN-US" style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT; mso-fareast-font-family: TimesNewRomanPSMT;">10.<span style="font-family: 'Times New Roman'; font-size: 7pt;"> </span></span><!--[endif]--><span lang="EN-US" style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT;">Produk harus disimpan sesuai dengan
kondisi penyimpanan yang tertera pada label pada kemasan, hal tersebut
berdasarkan hasil studi stabilitas.<o:p></o:p></span></div>
<div class="MsoListParagraphCxSpMiddle" style="margin-bottom: 0.0001pt; text-align: justify; text-indent: -18pt;">
<!--[if !supportLists]--><span lang="EN-US" style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT; mso-fareast-font-family: TimesNewRomanPSMT;">11.<span style="font-family: 'Times New Roman'; font-size: 7pt;"> </span></span><!--[endif]--><span lang="EN-US" style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT;">Catatan monitoring suhu harus dapat
direview. Alat pencatat harus terkalibrasi dan memiliki interval waktu
pencatatan. Pencatatan monitoring suhu harus dilakukan sampai produk tsb
daluwarsa atau sesuai dengan ketentuan yang berlaku.<o:p></o:p></span></div>
<div class="MsoListParagraphCxSpMiddle" style="margin-bottom: 0.0001pt; text-align: justify; text-indent: -18pt;">
<!--[if !supportLists]--><span lang="EN-US" style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT; mso-fareast-font-family: TimesNewRomanPSMT;">12.<span style="font-family: 'Times New Roman'; font-size: 7pt;"> </span></span><!--[endif]--><span lang="EN-US" style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT;">Pemetaan suhu dilakukan untuk
mengetahui keberagaman suhu dalam ruangan. Alat pencatat suhu harus diletakkan
pada titik yang terburuk (fluktuasi suhu tinggi).<o:p></o:p></span></div>
<div class="MsoListParagraphCxSpMiddle" style="margin-bottom: 0.0001pt; text-align: justify; text-indent: -18pt;">
<!--[if !supportLists]--><span lang="EN-US" style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT; mso-fareast-font-family: TimesNewRomanPSMT;">13.<span style="font-family: 'Times New Roman'; font-size: 7pt;"> </span></span><!--[endif]--><span lang="EN-US" style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT;">Harus dilakukan <i>stock opname </i>dengan periode tertentu. Jika terdapat selisih maka
harus dilakukan investigasi.<o:p></o:p></span></div>
<div class="MsoListParagraphCxSpLast" style="margin-bottom: 0.0001pt; text-align: justify;">
<br /></div>
Andi Usman Pharmahttp://www.blogger.com/profile/00236524553139613509noreply@blogger.com0tag:blogger.com,1999:blog-4997010120417470107.post-81639281010923695052013-01-29T02:31:00.001-08:002013-01-29T02:31:27.258-08:00Quality Management dalam CDOB<br />
<div align="center" class="MsoNormal" style="margin-bottom: 0.0001pt; text-align: center;">
<br /></div>
<div class="MsoListParagraphCxSpFirst" style="margin-bottom: 0.0001pt; text-align: justify; text-indent: -18pt;">
<!--[if !supportLists]--><span lang="EN-US" style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT; mso-fareast-font-family: TimesNewRomanPSMT;">1.<span style="font-family: 'Times New Roman'; font-size: 7pt;">
</span></span><!--[endif]--><span lang="EN-US" style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT;">Dalam
pelaksanaan penjaminan mutu harus didokum(<i>Quality Assurance</i>)entasikan kebijakan mutu yang
menjelaskan semua tujuan dan kebijakan distributor mengenai mutu yang dinyatakan
dan disahkan oleh manajemen.<o:p></o:p></span></div>
<div class="MsoListParagraphCxSpMiddle" style="margin-bottom: 0.0001pt; text-align: justify; text-indent: -18pt;">
<!--[if !supportLists]--><span lang="EN-US" style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT; mso-fareast-font-family: TimesNewRomanPSMT;">2.<span style="font-family: 'Times New Roman'; font-size: 7pt;">
</span></span><!--[endif]--><span lang="EN-US" style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT;">Manajemen
Mutu atau <i>Quality Management </i>harus mencakup :<o:p></o:p></span></div>
<div class="MsoListParagraphCxSpMiddle" style="margin: 0cm 0cm 0.0001pt 72pt; text-align: justify; text-indent: -18pt;">
<!--[if !supportLists]--><span lang="EN-US" style="font-family: Symbol; font-size: 12.0pt; mso-bidi-font-family: Symbol; mso-fareast-font-family: Symbol;">·<span style="font-family: 'Times New Roman'; font-size: 7pt;">
</span></span><!--[endif]--><span lang="EN-US" style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT;">Infratruktur
yang layak atau system mutu, mencakup struktur organisasi, prosedur, proses dan
sumber daya,<o:p></o:p></span></div>
<div class="MsoListParagraphCxSpMiddle" style="margin: 0cm 0cm 0.0001pt 72pt; text-align: justify; text-indent: -18pt;">
<!--[if !supportLists]--><span lang="EN-US" style="font-family: Symbol; font-size: 12.0pt; mso-bidi-font-family: Symbol; mso-fareast-font-family: Symbol;">·<span style="font-family: 'Times New Roman'; font-size: 7pt;">
</span></span><!--[endif]--><span lang="EN-US" style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT;">Tindakan
sistematik yang dibutuhkan untuk memberikan kepercayaan diri yang kuat bahwa
produk atau pelayanan dan dokumentasi akan selalu memenuhi persyaratan mutu.<o:p></o:p></span></div>
<div class="MsoListParagraphCxSpMiddle" style="margin-bottom: 0.0001pt; text-align: justify; text-indent: -18pt;">
<!--[if !supportLists]--><span lang="EN-US" style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT; mso-fareast-font-family: TimesNewRomanPSMT;">3.<span style="font-family: 'Times New Roman'; font-size: 7pt;">
</span></span><!--[endif]--><span lang="EN-US" style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT;">Ssitem
setidaknya harus mencakup prinsio-prinsip jaminan mutu yang terdapat pada Pedoman
dari WHO mengenai GMP (<i>Good manufacturing
Practices/ </i>Cara Pembuatan Obat yang Baik)<i> </i><o:p></o:p></span></div>
<div class="MsoListParagraphCxSpMiddle" style="margin-bottom: 0.0001pt; text-align: justify; text-indent: -18pt;">
<!--[if !supportLists]--><span lang="EN-US" style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT; mso-fareast-font-family: TimesNewRomanPSMT;">4.<span style="font-family: 'Times New Roman'; font-size: 7pt;">
</span></span><!--[endif]--><span lang="EN-US" style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT;">Semua
bagian yang terlibat dalam distribusi produk harus bersama-sama
bertanggungjawab terhadap mutu dan keamanan produk.<o:p></o:p></span></div>
<div class="MsoListParagraphCxSpMiddle" style="margin-bottom: 0.0001pt; text-align: justify; text-indent: -18pt;">
<!--[if !supportLists]--><span lang="EN-US" style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT; mso-fareast-font-family: TimesNewRomanPSMT;">5.<span style="font-family: 'Times New Roman'; font-size: 7pt;">
</span></span><!--[endif]--><span lang="EN-US" style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT;">Jika
menggunakan system perdagangan secara elektronik harus memiliki prosedur tetap
dan system yang kuat yang memiliki kemampuan untuk menelusuri dan tingkat
kepercayaan yang tinggi.<o:p></o:p></span></div>
<div class="MsoListParagraphCxSpMiddle" style="margin-bottom: 0.0001pt; text-align: justify; text-indent: -18pt;">
<!--[if !supportLists]--><span lang="EN-US" style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT; mso-fareast-font-family: TimesNewRomanPSMT;">6.<span style="font-family: 'Times New Roman'; font-size: 7pt;">
</span></span><!--[endif]--><span lang="EN-US" style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT;">Prosedur
pengadaan dan penyaluran yang sah harus ditetapkan untuk menjamin barang
diperoleh dari supplier yang disetujui dan disalurkan ke instansi yang sah. <o:p></o:p></span></div>
<div class="MsoListParagraphCxSpMiddle" style="margin-bottom: 0.0001pt; text-align: justify; text-indent: -18pt;">
<!--[if !supportLists]--><span lang="EN-US" style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT; mso-fareast-font-family: TimesNewRomanPSMT;">7.<span style="font-family: 'Times New Roman'; font-size: 7pt;">
</span></span><!--[endif]--><span lang="EN-US" style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT;">Semua
bagian yang berkaitan dengan jalur distribusi harus dapat ditelusuri dan mudah
digunakan tergantung pada jenis produk dan peraturan yang brlaku. Hal ini harus
tertuang dalam prosedur dan catatan yntuk menjamin kemampuan penelusuran
kembali produk yang didistribusikan.<o:p></o:p></span></div>
<div class="MsoListParagraphCxSpMiddle" style="margin-bottom: 0.0001pt; text-align: justify; text-indent: -18pt;">
<!--[if !supportLists]--><span lang="EN-US" style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT; mso-fareast-font-family: TimesNewRomanPSMT;">8.<span style="font-family: 'Times New Roman'; font-size: 7pt;">
</span></span><!--[endif]--><span lang="EN-US" style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT;">Audit
dan sertifikat dari instansi luar mengenai system mutu disarankan.<o:p></o:p></span></div>
<div class="MsoListParagraphCxSpLast" style="margin-bottom: 0.0001pt; text-align: justify; text-indent: -18pt;">
<!--[if !supportLists]--><span lang="EN-US" style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT; mso-fareast-font-family: TimesNewRomanPSMT;">9.<span style="font-family: 'Times New Roman'; font-size: 7pt;">
</span></span><!--[endif]--><span lang="EN-US" style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT;">Prosedur
tetap yang sah baik untuk kegiatan administrative amupun teknis harus dilakukan
dan diletakan di setiap bagian yang terkait.<o:p></o:p></span></div>
<div class="MsoNormal" style="margin-bottom: 0.0001pt; text-align: justify;">
<br /></div>
Andi Usman Pharmahttp://www.blogger.com/profile/00236524553139613509noreply@blogger.com3tag:blogger.com,1999:blog-4997010120417470107.post-1163764618666045832013-01-29T02:28:00.000-08:002013-01-29T02:28:13.288-08:00Organisasi, Management, dan Personalia dalam CDOB<br />
<div class="MsoNormal" style="margin-bottom: 0.0001pt; text-align: justify;">
<span lang="EN-US" style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT;">Berikut ini penjelasan mengenai Organisasi, Management, dan Personalia dalam Cara Distribusi Obat yang Baik (CDOB) atau <i>Good Distribution Practices (GDP).</i></span></div>
<div class="MsoNormal" style="margin-bottom: 0.0001pt; text-align: justify;">
<span lang="EN-US" style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT;"><i><br /></i></span></div>
<div class="MsoNormal" style="margin-bottom: 0.0001pt; text-align: center;">
<span lang="EN-US" style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT;"> </span><span style="font-family: 'Times New Roman', serif; font-size: 12pt;">ORGANISASI DAN MANAGEMENT</span></div>
<div align="center" class="MsoListParagraph" style="margin: 0cm 0cm 0.0001pt; text-align: center;">
<span lang="EN-US" style="font-family: "Times New Roman","serif"; font-size: 12.0pt;"><o:p></o:p></span></div>
<div class="MsoListParagraphCxSpFirst" style="margin-bottom: 0.0001pt; text-align: justify; text-indent: -18pt;">
<!--[if !supportLists]--><span lang="EN-US" style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT; mso-fareast-font-family: TimesNewRomanPSMT;">1.<span style="font-family: 'Times New Roman'; font-size: 7pt;"> </span></span><span lang="EN-US" style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT;">Organisasi
atau distributor harus memiliki izin dari pemerintah dan mempunyai kemampuan
dalam menjaga mutu produk.<o:p></o:p></span></div>
<div class="MsoListParagraphCxSpMiddle" style="margin-bottom: 0.0001pt; text-align: justify; text-indent: -18pt;">
<!--[if !supportLists]--><span lang="EN-US" style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT; mso-fareast-font-family: TimesNewRomanPSMT;">2.<span style="font-family: 'Times New Roman'; font-size: 7pt;">
</span></span><!--[endif]--><span lang="EN-US" style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT;">Struktur
organisasi harus kuat dan memiliki pembagian tugas, tanggungjawab dan
kewenangan yang jelas.<o:p></o:p></span></div>
<div class="MsoListParagraphCxSpMiddle" style="margin-bottom: 0.0001pt; text-align: justify; text-indent: -18pt;">
<!--[if !supportLists]--><span lang="EN-US" style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT; mso-fareast-font-family: TimesNewRomanPSMT;">3.<span style="font-family: 'Times New Roman'; font-size: 7pt;">
</span></span><!--[endif]--><span lang="EN-US" style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT;">Personel
harus mampu menjaga mutu dari setiap produk dan mempunyai kemampuan
mengidentifikasi dan memberikan solusi yang benar ketika terdapat sebuah
penyimpangan.<o:p></o:p></span></div>
<div class="MsoListParagraphCxSpLast" style="margin-bottom: 0.0001pt; text-align: justify; text-indent: -18pt;">
<!--[if !supportLists]--><span lang="EN-US" style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT; mso-fareast-font-family: TimesNewRomanPSMT;">4.<span style="font-family: 'Times New Roman'; font-size: 7pt;">
</span></span><!--[endif]--><span lang="EN-US" style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT;">Prosedur
keamanan yang berhubungan pada semua aspek baik personel, bangunan, lingkungan,
produk harus ditetapkan.<o:p></o:p></span></div>
<div class="MsoNormal" style="margin-bottom: 0.0001pt;">
<br /></div>
<div align="center" class="MsoNormal" style="margin-bottom: 0.0001pt; text-align: center;">
<span lang="EN-US" style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT;">PERSONALIA<o:p></o:p></span></div>
<div class="MsoListParagraphCxSpFirst" style="margin-bottom: 0.0001pt; text-align: justify; text-indent: -18pt;">
<!--[if !supportLists]--><span lang="EN-US" style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT; mso-fareast-font-family: TimesNewRomanPSMT;">1.<span style="font-family: 'Times New Roman'; font-size: 7pt;">
</span></span><!--[endif]--><span lang="EN-US" style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT;">Semua
orang yang terlibat dalam proses distribusi harus dilatih mengenai persyaratan
GDP dan mampu memenuhi persyaratan tsb.<o:p></o:p></span></div>
<div class="MsoListParagraphCxSpMiddle" style="margin-bottom: 0.0001pt; text-align: justify; text-indent: -18pt;">
<!--[if !supportLists]--><span lang="EN-US" style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT; mso-fareast-font-family: TimesNewRomanPSMT;">2.<span style="font-family: 'Times New Roman'; font-size: 7pt;">
</span></span><!--[endif]--><span lang="EN-US" style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT;">Personel
kunci yang terlibat dalam distribusi harus mempunyai kemampuan dan pengalaman
yang cukup sesuai dengan tanggungjawabnya untuk menjamin produk di
distrubusikan dengan tepat.<o:p></o:p></span></div>
<div class="MsoListParagraphCxSpMiddle" style="margin-bottom: 0.0001pt; text-align: justify; text-indent: -18pt;">
<!--[if !supportLists]--><span lang="EN-US" style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT; mso-fareast-font-family: TimesNewRomanPSMT;">3.<span style="font-family: 'Times New Roman'; font-size: 7pt;">
</span></span><!--[endif]--><span lang="EN-US" style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT;">Personel
harus memiliki kualifikasi dan pengalaman sesuai persyaratan dan peraturan yang
berlaku.<o:p></o:p></span></div>
<div class="MsoListParagraphCxSpMiddle" style="margin-bottom: 0.0001pt; text-align: justify; text-indent: -18pt;">
<!--[if !supportLists]--><span lang="EN-US" style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT; mso-fareast-font-family: TimesNewRomanPSMT;">4.<span style="font-family: 'Times New Roman'; font-size: 7pt;">
</span></span><!--[endif]--><span lang="EN-US" style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT;">Personel
harus memiliki kesehatan fisik dan mental yang baik, serta diadakan pemeriksaan
kesehatan secara berkala.<o:p></o:p></span></div>
<div class="MsoListParagraphCxSpMiddle" style="margin-bottom: 0.0001pt; text-align: justify; text-indent: -18pt;">
<!--[if !supportLists]--><span lang="EN-US" style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT; mso-fareast-font-family: TimesNewRomanPSMT;">5.<span style="font-family: 'Times New Roman'; font-size: 7pt;">
</span></span><!--[endif]--><span lang="EN-US" style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT;">Personel
harus mendapat pelatihan dasar dan berkala yang sesuai dengan pekerjaannya.<o:p></o:p></span></div>
<div class="MsoListParagraphCxSpMiddle" style="margin-bottom: 0.0001pt; text-align: justify; text-indent: -18pt;">
<!--[if !supportLists]--><span lang="EN-US" style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT; mso-fareast-font-family: TimesNewRomanPSMT;">6.<span style="font-family: 'Times New Roman'; font-size: 7pt;">
</span></span><!--[endif]--><span lang="EN-US" style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT;">Personel
yang menangani bahan berbahaya harus mendapatkan pelatihan khusus.<o:p></o:p></span></div>
<div class="MsoListParagraphCxSpMiddle" style="margin-bottom: 0.0001pt; text-align: justify; text-indent: -18pt;">
<!--[if !supportLists]--><span lang="EN-US" style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT; mso-fareast-font-family: TimesNewRomanPSMT;">7.<span style="font-family: 'Times New Roman'; font-size: 7pt;">
</span></span><!--[endif]--><span lang="EN-US" style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT;">Setiap
pelatihan harus didokumentasikan dan disimpan dengan baik.<o:p></o:p></span></div>
<div class="MsoListParagraphCxSpMiddle" style="margin-bottom: 0.0001pt; text-align: justify; text-indent: -18pt;">
<!--[if !supportLists]--><span lang="EN-US" style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT; mso-fareast-font-family: TimesNewRomanPSMT;">8.<span style="font-family: 'Times New Roman'; font-size: 7pt;">
</span></span><!--[endif]--><span lang="EN-US" style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT;">Personel
yang terlibat dalam distribusi harus memakai alat pelindung diri sesuai dengan
pekerjaannya khususnya yang menangani produk-produk berbahaya.<o:p></o:p></span></div>
<div class="MsoListParagraphCxSpMiddle" style="margin-bottom: 0.0001pt; text-align: justify; text-indent: -18pt;">
<!--[if !supportLists]--><span lang="EN-US" style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT; mso-fareast-font-family: TimesNewRomanPSMT;">9.<span style="font-family: 'Times New Roman'; font-size: 7pt;">
</span></span><!--[endif]--><span lang="EN-US" style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT;">Harus
terdapat prosedur yang menangani kebersihan dan kesehatan diri.<o:p></o:p></span></div>
<div class="MsoListParagraphCxSpLast" style="margin-bottom: 0.0001pt; text-align: justify; text-indent: -18pt;">
<!--[if !supportLists]--><span lang="EN-US" style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT; mso-fareast-font-family: TimesNewRomanPSMT;">10.<span style="font-family: 'Times New Roman'; font-size: 7pt;"> </span></span><!--[endif]--><span lang="EN-US" style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT;">Prosedur dan peralatan kecelakaan
pertama serta kondisi darurat harus tersedia.<o:p></o:p></span></div>
Andi Usman Pharmahttp://www.blogger.com/profile/00236524553139613509noreply@blogger.com0tag:blogger.com,1999:blog-4997010120417470107.post-66250985229031991282013-01-28T06:27:00.001-08:002013-01-30T07:07:39.085-08:00Proses Pembuatan Sediaan Suspensi<br />
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<span style="font-family: "Times New Roman","serif"; mso-ansi-language: IN;"> Pembuatan suspensi diawali dengan pembuatan <i>sirupus
simplex</i> yang kemudian dilakukan penyaringan dengan ukuran mesh yang dapat
menyaring partikel kotoran. Setelah itu dilakukan pembuatan <i>suspending agent</i>.
Setelah larutan <i>suspending agent</i> mengembang maka dilakukan penghalusan
dengan menggunakan <i>colloid mill</i>. Bahan aktif yang tidak larut harus
dilakukan proses pembasahan terlebih dahulu. Setelah masing-masing bahan siap,
maka dilakukan proses pencampuran di dalam <i>mixing tank</i>. Bahan-bahan
pembantu ditambahkan ke dalam campuran
sediaan dalam kondisi terlarut dalam air. Setelah suspensi terbentuk maka
ditambahkan air sampai volume yang diinginkan. Proses terakhir adalah suspensi
dihaluskan dengan <i>colloid mill</i>.</span></div>
<div class="MsoNormal" style="line-height: 150%; margin-left: 21.3pt; tab-stops: 49.65pt; text-align: justify; text-indent: -21.3pt;">
<span style="font-family: 'Times New Roman', serif; font-size: 12pt;"> Selanjutnya sampel diambil sebanyak 500 ml untuk
pengujian laboratorium kemudian hasil <i>mixing</i> diberi label “Dalam
Pemeriksaan”. Pengujian yang dilakukan terhadap suspensi antara lain;
organoleptis, pH, berat jenis, viskositas serta kadat zat aktif. Setelah lulus
hasil pengujian, maka suspensi siap di-<i>filling </i>ke dalam botol dengan
menggunakan mesin <i> Liquid Filling </i>and <i>Cropping Machine</i>.
Secara skematis alur proses pembuatan suspensi lihat pada gambar.</span></div>
<div class="MsoNormal" style="line-height: 150%; margin-left: 21.3pt; tab-stops: 49.65pt; text-align: justify; text-indent: -21.3pt;">
<span style="font-family: 'Times New Roman', serif; font-size: 12pt;"><br /></span></div>
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<a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEiQvN8W9YfKSP0388gVE6hNESCLlQiDiY9PBxZuHQxRoY8_AF799hSkkav42i_Y7x1miVM4qCDvEhNcqU-jlsNGwvI-5h1Q-sAoU8VKpzop5DwAfYNg-95192lYUQtPS1ZrTuSZam0V6u0/s1600/proses+pembuatan+sediaan+suspensi.jpg" imageanchor="1" style="margin-left: 1em; margin-right: 1em;"><img border="0" height="640" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEiQvN8W9YfKSP0388gVE6hNESCLlQiDiY9PBxZuHQxRoY8_AF799hSkkav42i_Y7x1miVM4qCDvEhNcqU-jlsNGwvI-5h1Q-sAoU8VKpzop5DwAfYNg-95192lYUQtPS1ZrTuSZam0V6u0/s640/proses+pembuatan+sediaan+suspensi.jpg" width="502" /></a></div>
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Andi Usman Pharmahttp://www.blogger.com/profile/00236524553139613509noreply@blogger.com0tag:blogger.com,1999:blog-4997010120417470107.post-83862452232763270622013-01-28T06:18:00.000-08:002013-01-28T06:19:54.263-08:00Uji Waktu Hancur (Disintegration test) Tablet dan Kapsul<span class="Apple-style-span" style="font-family: Arial, sans-serif; font-size: 12px; line-height: 18px;">Waktu hancur tablet adalah waktu yang diperlukan untuk hancurnya tablet<strong> </strong>dalam waktu yang sesuai sehingga tidak ada bagian yang tertinggal diatas kasa. Uji ini dimaksudkan untuk menetapkan kesesuaian batas waktu hancur yang tertera dalam masing-masing monografi, kecuali pada etiket dinyatakan bahwa tablet atau kapsul digunakan sebagai tablet hisap atau dikunyah atau dirancang untuk pelepasan kandungan obat secara bertahap dalam jangka waktu tertentu atau melepaskan obat dalam dua periode berbeda atau lbih dengan jarak waktu yang jelas diantara periode pelepasan tersebut.</span><br />
<span class="Apple-style-span" style="font-family: Arial, sans-serif; font-size: 12px; line-height: 18px;"><br />
</span><br />
<span class="Apple-style-span" style="font-family: Arial, sans-serif; font-size: 12px; line-height: 18px;">Uji waktu hancur tidak menyatakan bahwa sediaan atau bahan aktifnya terlarut sempurna. Sediaan dinyatakan hancur sempurna bila sisa sediian yag tertinggal pada kasa alat uji merupakam masa lunak yang tidak mempunyai inti yang jelas, kecuali bagian dari penyalut atau cangkang kapsul yang tidak larut.</span><br />
<span class="Apple-style-span" style="font-family: Arial, sans-serif; font-size: 12px; line-height: 18px;"><br />
</span><br />
<span class="Apple-style-span" style="font-family: Arial, sans-serif; font-size: 12px; line-height: 18px;"><b>Alat.</b> Alat terdiri suatu rangkain keranjang, gelas piala berukuran 1000 ml, termostat untuk memanaskan cairan media antara 35 sampai 39 derajat celcius dan alat untuk menaik turunkan keranjang dalam cairan media pada frekuensi yang tetap antara 29 kali hingga 32 kali per menit melalui jarak tidak kurang dari 5,3 cm dan tidak lebih dari 5,7 cm. Volume cairan dalam wadah sedemikian sehinga pada titik tertinggi gerakan ke atas, kawat kasa berada paling sedikit 2,5 cm dibawah permukaan cairan dan pada gerakan ke bawah berjarak tidak kurang dari 2,5 cm dari dasar wadah. wakru yang diperlukan untuk bergerak ke atas sama dengan waktu yang diperlukan untuk bergerak ke bawah dan perubahan pada arah gerakan merupakan perubahan yang halus, bukan merupakan gerakan yang tiba-tiba dan kasar. Rangkaian keranjang bergerak vertikal sepanjang sumbunya, tanpa gerakan horisontal yang berarti atau gerakan sumbu dari posisi vertikalnya.</span><br />
<span class="Apple-style-span" style="font-family: Arial, sans-serif; font-size: 12px; line-height: 18px;"><br />
</span><br />
<span class="Apple-style-span" style="font-family: Arial, sans-serif; font-size: 12px; line-height: 18px;"><b>Prosedur. </b>Masukkan 1 tablet pada masing-masing tabung dari keranjang, masukkan 1 cakram pada tiap-tiap tabung dan jalankan alat, gunakan air bersuhu 37 +/- 2 derajat celcius sebaai media kecuali dinyatakan lain pada tiap-tiap monografi.</span>Andi Usman Pharmahttp://www.blogger.com/profile/00236524553139613509noreply@blogger.com0tag:blogger.com,1999:blog-4997010120417470107.post-78500873843381462972013-01-28T06:16:00.000-08:002013-01-30T07:07:15.470-08:00Proses Pembuatan Sediaan Sirup<br />
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Proses pembuatan sirup dimulai dengan pencucian botol
dengan menggunakan <i>aquademineralisata</i>. Botol kemudian dikeringkan dalam
oven <i>double door</i>. Proses pencucian botol seluruhnya ditangani oleh
bagian pencucian botol.<o:p></o:p></div>
<div class="MsoTitle" style="line-height: 150%; margin-left: 21.3pt; tab-stops: 49.65pt; text-align: justify; text-indent: -21.3pt;">
Tahap
selanjutnya adalah pembuatan <i>syrupus simplex</i> yang kemudian dicampur
dengan bahan aktif dan bahan tambahan lain dalam<i> mixing tank</i>. Pengisian sirup ke dalam botol dengan menggunakan <i> Liquid Filling Machine</i> and <i>Cappering Machine </i>sesuai dengan volume yang
dikehendaki. Setelah sirup diisikan, botol ditutup (<i>capping)</i> secara
otomatis. <o:p></o:p></div>
<div class="MsoTitle" style="line-height: 150%; margin-left: 21.3pt; tab-stops: 21.3pt; text-align: justify; text-indent: -21.3pt;">
Pengawasan mutu pada pembuatan sirup, meliputi :<o:p></o:p></div>
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<!--[if !supportLists]-->a).<span style="font-size: 7pt; line-height: normal;"> </span><!--[endif]-->Proses <i>mixing/filtrasi</i>,
yaitu pemeriksaan pH, viskositas suspensi, kadar zat aktif, homogenitas, dan
berat jenis.<o:p></o:p></div>
<div class="MsoTitle" style="line-height: 150%; margin-left: 21.3pt; mso-list: l0 level1 lfo1; tab-stops: 21.3pt list 117.0pt; text-align: justify; text-indent: -21.3pt;">
<!--[if !supportLists]-->b).<span style="font-size: 7pt; line-height: normal;"> </span><!--[endif]-->Proses <i>filling</i> yaitu
pemeriksaan keseragaman volume.<o:p></o:p></div>
<div class="MsoNormal" style="line-height: 150%; margin-left: 21.3pt; mso-list: l0 level1 lfo1; tab-stops: 21.3pt list 117.0pt; text-align: justify; text-indent: -21.3pt;">
<!--[if !supportLists]--><span style="font-family: "Times New Roman","serif"; mso-ansi-language: IN;">c).<span style="font-family: 'Times New Roman'; font-size: 7pt; line-height: normal;">
</span></span><!--[endif]--><span style="font-family: "Times New Roman","serif"; mso-ansi-language: IN;">Proses <i>capping</i> yaitu pemeriksaan kebocoran.<o:p></o:p></span></div>
<span style="font-family: "Calibri","sans-serif"; font-size: 12.0pt; mso-ansi-language: IN; mso-bidi-font-family: Calibri; mso-bidi-language: AR-SA; mso-fareast-font-family: "Times New Roman"; mso-fareast-language: AR-SA;">Secara skematis alur proses pembuatan sirup
dilihat pada gambar</span><br />
<span style="font-family: "Calibri","sans-serif"; font-size: 12.0pt; mso-ansi-language: IN; mso-bidi-font-family: Calibri; mso-bidi-language: AR-SA; mso-fareast-font-family: "Times New Roman"; mso-fareast-language: AR-SA;"><br /></span>
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<a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEi2jeuXzJ4_hZ1_2ARKQ045NfwJDTMNq2YhcpdSx-WvA8MiqHRznE7td033G-35duoJo8eVB6Wq2-dZonnT7Xq2sJHlgQakEg9rG26gErkaMiSPRMv8R-21MdmX7uRgJNVGwCOEr_T0wBw/s1600/proses+pembuatan+sediaan+sirup.jpg" imageanchor="1" style="margin-left: 1em; margin-right: 1em;"><img border="0" height="640" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEi2jeuXzJ4_hZ1_2ARKQ045NfwJDTMNq2YhcpdSx-WvA8MiqHRznE7td033G-35duoJo8eVB6Wq2-dZonnT7Xq2sJHlgQakEg9rG26gErkaMiSPRMv8R-21MdmX7uRgJNVGwCOEr_T0wBw/s640/proses+pembuatan+sediaan+sirup.jpg" width="470" /></a></div>
<span style="font-family: "Calibri","sans-serif"; font-size: 12.0pt; mso-ansi-language: IN; mso-bidi-font-family: Calibri; mso-bidi-language: AR-SA; mso-fareast-font-family: "Times New Roman"; mso-fareast-language: AR-SA;"><br /></span>Andi Usman Pharmahttp://www.blogger.com/profile/00236524553139613509noreply@blogger.com3tag:blogger.com,1999:blog-4997010120417470107.post-2558588946933093452013-01-26T20:27:00.000-08:002013-01-30T07:35:06.204-08:00Proses Pembuatan Sediaan Kapsul<span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; mso-ansi-language: IN; mso-bidi-font-family: Calibri; mso-bidi-language: AR-SA; mso-fareast-font-family: "Times New Roman"; mso-fareast-language: AR-SA;">Keuntungan bentuk sediaan kapsul :</span><br />
<span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; mso-ansi-language: IN; mso-bidi-font-family: Calibri; mso-bidi-language: AR-SA; mso-fareast-font-family: "Times New Roman"; mso-fareast-language: AR-SA;">1. Menutupi bau dan rasa yang tidak enak</span><br />
<span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; mso-ansi-language: IN; mso-bidi-font-family: Calibri; mso-bidi-language: AR-SA; mso-fareast-font-family: "Times New Roman"; mso-fareast-language: AR-SA;">2. Menghindari kontak langsung dengan udara dan sinar matahari</span><br />
<span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; mso-ansi-language: IN; mso-bidi-font-family: Calibri; mso-bidi-language: AR-SA; mso-fareast-font-family: "Times New Roman"; mso-fareast-language: AR-SA;">3. Memperbaiki penampilan</span><br />
<span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; mso-ansi-language: IN; mso-bidi-font-family: Calibri; mso-bidi-language: AR-SA; mso-fareast-font-family: "Times New Roman"; mso-fareast-language: AR-SA;">4. Dapt untuk 2 sediaan yang tidak tercampur secara fisis</span><br />
<span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; mso-ansi-language: IN; mso-bidi-font-family: Calibri; mso-bidi-language: AR-SA; mso-fareast-font-family: "Times New Roman"; mso-fareast-language: AR-SA;"><br /></span>
<span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; mso-ansi-language: IN; mso-bidi-font-family: Calibri; mso-bidi-language: AR-SA; mso-fareast-font-family: "Times New Roman"; mso-fareast-language: AR-SA;">Proses
pengolahan kapsul dimulai dari penimbangan bahan baku yang diluluskan oleh bagian
<i>Quality assurance</i>. Ada dua metode pengolahan kapsul, yaitu pencampuran
langsung serbuk menggunakan <i>mixer</i> atau melalui proses granulasi
basah. Pada metode granulasi basah, dilakukan proses granulasi seperti pada
pembuatan tablet, kemudian granul yang dihasilkan dicampur dengan bahan
lainnya. Setelah itu dilakukan proses pengisian dengan menggunakan <i>Filling
Capsule Machine</i>.
Setelah proses pengisian, tahap selanjutnya adalah <i>polishing</i> kapsul yang
berguna untuk menghilangkan serbuk yang lengket pada permukaan cangkang kapsul
sehingga kapsul tampak lebih bersih dan mengkilap. Alur proses pembuatan kapsul
dapat dilihat pada gambar.</span><br />
<span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; mso-ansi-language: IN; mso-bidi-font-family: Calibri; mso-bidi-language: AR-SA; mso-fareast-font-family: "Times New Roman"; mso-fareast-language: AR-SA;"><br /></span>
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<div style="text-align: center;">
<span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; mso-ansi-language: IN; mso-bidi-font-family: Calibri; mso-bidi-language: AR-SA; mso-fareast-font-family: "Times New Roman"; mso-fareast-language: AR-SA;"><br /></span></div>
Andi Usman Pharmahttp://www.blogger.com/profile/00236524553139613509noreply@blogger.com0tag:blogger.com,1999:blog-4997010120417470107.post-39295815243236394642013-01-26T19:39:00.000-08:002013-01-30T07:36:08.773-08:00Proses Pembuatan Tablet Salut<br />
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<span style="font-family: "Times New Roman","serif"; mso-ansi-language: IN;"> Penyalutan adalah proses
menutupi tablet dengan suatu lapisan yang tipis dari zat yang umumnya<i> inert</i>. Penyalutan mempunyai beberapa tujuan, antara lain:<o:p></o:p></span></div>
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<!--[if !supportLists]--><span style="font-family: "Times New Roman","serif"; mso-ansi-language: IN;">a)<span style="font-family: 'Times New Roman'; font-size: 7pt; line-height: normal;"> </span></span><span style="font-family: "Times New Roman","serif"; mso-ansi-language: IN;">Menutupi rasa dan bau yang tidak enak dari zat berkhasiat
dan memudahkan pasien untuk menelan<o:p></o:p></span></div>
<div class="MsoNormal" style="line-height: 150%; margin-left: 42.55pt; mso-list: l2 level1 lfo3; tab-stops: 42.55pt; text-align: justify; text-indent: -21.25pt;">
<!--[if !supportLists]--><span style="font-family: "Times New Roman","serif"; mso-ansi-language: IN;">b)<span style="font-family: 'Times New Roman'; font-size: 7pt; line-height: normal;">
</span></span><!--[endif]--><span style="font-family: "Times New Roman","serif"; mso-ansi-language: IN;">Melindungi zat berkhasiat terhadap pengaruh luar, seperti
kelembaban, oksigen, cahaya, dll<o:p></o:p></span></div>
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<!--[if !supportLists]--><span style="font-family: "Times New Roman","serif"; mso-ansi-language: IN;">c)<span style="font-family: 'Times New Roman'; font-size: 7pt; line-height: normal;">
</span></span><span style="font-family: "Times New Roman","serif"; mso-ansi-language: IN;">Mengendalikan pelepasan obat (zat berkhasiat) dari tablet<o:p></o:p></span></div>
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<!--[if !supportLists]--><span style="font-family: "Times New Roman","serif"; mso-ansi-language: IN;">d)<span style="font-family: 'Times New Roman'; font-size: 7pt; line-height: normal;"> </span></span><span lang="EN-US" style="font-family: "Times New Roman","serif";">M</span><span style="font-family: "Times New Roman","serif"; mso-ansi-language: IN;">elindungi
obat dari suasana dalam lambung; meningkatkan daya tarik (estetika) dan
mempermudah identifikasi sediaan<o:p></o:p></span></div>
<div class="MsoNormal" style="line-height: 150%; margin-left: 42.55pt; mso-list: l2 level1 lfo3; tab-stops: 42.55pt; text-align: justify; text-indent: -21.25pt;">
<!--[if !supportLists]--><span style="font-family: "Times New Roman","serif"; mso-ansi-language: IN;">e)<span style="font-family: 'Times New Roman'; font-size: 7pt; line-height: normal;"> </span></span><span style="font-family: "Times New Roman","serif"; mso-ansi-language: IN;">Mencegah inkompatibilitas di antara zat berkhasiat yang
terdapat di dalam tablet<o:p></o:p></span></div>
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<!--[if !supportLists]--><span style="font-family: "Times New Roman","serif"; mso-ansi-language: IN;">f)<span style="font-family: 'Times New Roman'; font-size: 7pt; line-height: normal;">
</span></span><span lang="EN-US" style="font-family: "Times New Roman","serif";">M</span><span style="font-family: "Times New Roman","serif"; mso-ansi-language: IN;">enggabungkan
obat lain atau membantu formula dalam penyalutan (misal kadar terlalu kecil dan
terlalu besar).<o:p></o:p></span></div>
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<span style="font-family: "Times New Roman","serif"; mso-ansi-language: IN;"> Faktor-faktor yang mempengaruhi
proses penyalutan antara lain sifat dan bentuk tablet inti (bentuk yang ideal :
sferis, elips, bikonveks, bulat dan bikonveks oval sehingga tablet mudah
berputar dan bergerak)</span><span lang="EN-US" style="font-family: "Times New Roman","serif";">;</span><span style="font-family: "Times New Roman","serif"; mso-ansi-language: IN;"> kekerasan
tablet harus cukup, sehingga dapat tahan terhadap benturan selama penyalutan,
kerapuhan sekecil mungkin sehingga tidak menimbulkan banyak debu); peralatan
yang digunakan; formulasi lapisan penyalut; kondisi ruangan </span><span lang="EN-US" style="font-family: "Times New Roman","serif";">(</span><span style="font-family: "Times New Roman","serif"; mso-ansi-language: IN;">suhu,
kelembaban, kandungan debu, dll</span><span lang="EN-US" style="font-family: "Times New Roman","serif";">)</span><span style="font-family: "Times New Roman","serif"; mso-ansi-language: IN;">; serta
keahlian operator.<o:p></o:p></span></div>
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<span style="font-family: "Times New Roman","serif"; mso-ansi-language: IN;"> </span><span lang="EN-US" style="font-family: "Times New Roman","serif";"> </span><span style="font-family: "Times New Roman","serif"; mso-ansi-language: IN;">Tablet hasil penyalutan harus memenuhi syarat yaitu permukaan tablet licin; lapisan
penyalut harus stabil dan tidak boleh ada cacat; untuk tablet salut yang
berwarna maka warnanya harus rata dan tidak boleh terjadi migrasi zat warna;
lapisan penyalut harus mampu melindungi tablet inti dari pengaruh udara,
kelembaban, dan cahaya; lapisan penyalut harus memiliki rasa netral atau enak;
serta penyalutan diusahakan setipis mungkin dan tidak boleh merusak obatnya. <o:p></o:p></span></div>
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<span style="font-family: "Times New Roman","serif"; mso-ansi-language: IN;"> </span><span lang="EN-US" style="font-family: "Times New Roman","serif";"><o:p></o:p></span></div>
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<span style="font-family: "Times New Roman","serif"; mso-ansi-language: IN;"> Tablet
atau kaplet salut terdiri dari :<o:p></o:p></span></div>
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<!--[if !supportLists]-->a)<span style="font-size: 7pt; line-height: normal;">
</span><!--[endif]-->Tablet /
Kaplet Salut Gula<o:p></o:p></div>
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<span style="font-family: "Times New Roman","serif"; mso-ansi-language: IN;"> Proses penyalutan gula terdiri
dari beberapa tahap yang lamanya berkisar antara beberapa jam hingga beberapa
hari. Tahap-tahap penyalutan gula adalah :<o:p></o:p></span></div>
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<!--[if !supportLists]--><span style="font-family: "Times New Roman","serif"; mso-ansi-language: IN;">(1)<span style="font-family: 'Times New Roman'; font-size: 7pt; line-height: normal;"> </span></span><!--[endif]--><span style="font-family: "Times New Roman","serif"; mso-ansi-language: IN;">Penyegelan
tablet inti (<i>Sealing</i>)<o:p></o:p></span></div>
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<span style="font-family: "Times New Roman","serif"; mso-ansi-language: IN;"> Tujuan penyegelan adalah untuk
mencegah penyusupan air ke dalam tablet inti. Penggunaan larutan <i>seal
coating</i> yang terlalu banyak akan mempengaruhi disolusi dan disintegrasi
obat, namun penyegelan yang kurang akan menyebabkan stabilitas tablet inti
terganggu (tablet pecah / <i>cracking</i>).<o:p></o:p></span></div>
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<!--[if !supportLists]--><span style="font-family: "Times New Roman","serif"; mso-ansi-language: IN;">(2)<span style="font-family: 'Times New Roman'; font-size: 7pt; line-height: normal;"> </span></span><!--[endif]--><span style="font-family: "Times New Roman","serif"; mso-ansi-language: IN;">Pelapisan
dasar (<i>Sub Coating</i>)<o:p></o:p></span></div>
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<span style="font-family: "Times New Roman","serif"; mso-ansi-language: IN;"> Tujuan <i>sub coating</i> adalah untuk membulatkan tepi
tablet dan menutup sudut-sudut kritis pada tablet inti serta meningkatkan berat
tablet (penyalutan gula dapat meningkatkan berat tablet 50-100%). Variasi bobot
tablet salut gula maksimal 6,5 %.<o:p></o:p></span></div>
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<!--[if !supportLists]--><span style="font-family: "Times New Roman","serif"; mso-ansi-language: IN;">(3)<span style="font-family: 'Times New Roman'; font-size: 7pt; line-height: normal;"> </span></span><!--[endif]--><span style="font-family: "Times New Roman","serif"; mso-ansi-language: IN;">Pewarnaan (<i>Coloring</i>)<o:p></o:p></span></div>
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<span style="font-family: "Times New Roman","serif"; mso-ansi-language: IN;"> </span><span lang="EN-US" style="font-family: "Times New Roman","serif";"> </span><span style="font-family: "Times New Roman","serif"; mso-ansi-language: IN;">Tujuan
pewarnaan adalah untuk menutupi atau mengisi cacat pada permukaan tablet yang
disebabkan oleh tahap pelapisan dasar serta memberikan warna yang diinginkan
bagi tablet. Umumnya pewarnaan ditambahkan pada saat tablet sudah cukup halus
agar hasil akhir tablet tidak berbinik-bintik dan terjadi migrasi warna.<o:p></o:p></span></div>
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<!--[if !supportLists]--><span style="font-family: "Times New Roman","serif"; mso-ansi-language: IN;">(4)<span style="font-family: 'Times New Roman'; font-size: 7pt; line-height: normal;"> </span></span><!--[endif]--><span style="font-family: "Times New Roman","serif"; mso-ansi-language: IN;">Penghalusan
(<i>Smoothing</i>)<o:p></o:p></span></div>
<div class="MsoNormal" style="line-height: 150%; margin-left: 21.3pt; mso-pagination: lines-together; tab-stops: 49.65pt; text-align: justify;">
<span lang="EN-US" style="font-family: "Times New Roman","serif";"> </span><span style="font-family: "Times New Roman","serif"; mso-ansi-language: IN;">Tujuan
penghalusan adalah untuk mengikis permukaan tablet yang kasar yang disebabkan
oleh tahap pelapisan dan atau pewarnaan sehingga menghasilkan tablet halus,
mengkilap, dan anggun.</span><span style="font-family: 'Times New Roman', serif; line-height: 150%;"> </span></div>
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<!--[if !supportLists]--><span lang="EN-US" style="font-family: "Times New Roman","serif";">(5)<span style="font-family: 'Times New Roman'; font-size: 7pt; line-height: normal;"> </span></span><!--[endif]--><span style="font-family: "Times New Roman","serif"; mso-ansi-language: IN;">Pengkilapan
(<i>Polishing</i></span><span lang="EN-US" style="font-family: "Times New Roman","serif";">)<o:p></o:p></span></div>
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<span style="font-family: "Times New Roman","serif"; mso-ansi-language: IN;"> Tujuan pengkilapan adalah untuk
memperoleh hasil akhir (tablet salut yang mengkilap, licin, halus, dan menawan.
Hal yang perlu diperhatikan dalam tahap ini adalah jangan digunakan panas
berlebih karena bubuk wax akan menempel pada tablet, serta hentikan proses <i>polishing</i>
jika tablet sudah mengkilap, jika terlalu lama justru tabletakan rusak dan
tidak mengkilap</span><span lang="EN-US" style="font-family: "Times New Roman","serif";">
(buram)</span><span style="font-family: "Times New Roman","serif"; mso-ansi-language: IN;">.<o:p></o:p></span></div>
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<span style="font-family: "Times New Roman","serif"; mso-ansi-language: IN;"><br /></span></div>
<div class="MsoHeader" style="line-height: 150%; margin-left: 21.3pt; mso-list: l1 level1 lfo2; mso-pagination: none; tab-stops: 21.3pt list 54.0pt; text-align: justify; text-indent: -21.3pt;">
<!--[if !supportLists]-->b)<span style="font-size: 7pt; line-height: normal;">
</span><!--[endif]-->Tablet /
Kaplet Salut Selaput (<i>film coating</i>)<o:p></o:p></div>
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</v:shape><![endif]--><!--[if !vml]--><!--[endif]--> Tablet salut film
dikarakterisasikan sebagai tablet inti yang disalut dengan lapisan relatif
tipis dari material yang cocok. Kelebihan metode ini dibanding salut gula
adalah : waktu pengerjaannya relatif lebih cepat; lebih efisien karena
membutuhkan tenaga dan bahan lebih sedikit; luas area produksi bisa dikurangi;
hanya sedikit menambah berat tablet (2-4%), dan variasi bobot maksimal yang
diperbolehkan maksimal 5%; dan initial (logo) tablet inti masih tampak,
sehingga mudah identifikasi. Alur proses pembuatan tablet/kaplet salut dapat
dilihat pada gambar.</div>
<div class="separator" style="clear: both; text-align: center;">
<a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEiQOFjeqaaaC22yBfM2HrPmt6vUD-AlOVcC2tQ7zZejEgUtBqSKvF5JTDRCdw6DLDGpsxW87x7DH9gn5EeqyvDJ-zNdaAUsCeNffao1ayl-8Nse1zaZAPV3lEokPP-sMCsH4quJtIwvNYU/s1600/tablet+salut.jpg" imageanchor="1" style="margin-left: 1em; margin-right: 1em;"><img border="0" height="640" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEiQOFjeqaaaC22yBfM2HrPmt6vUD-AlOVcC2tQ7zZejEgUtBqSKvF5JTDRCdw6DLDGpsxW87x7DH9gn5EeqyvDJ-zNdaAUsCeNffao1ayl-8Nse1zaZAPV3lEokPP-sMCsH4quJtIwvNYU/s640/tablet+salut.jpg" width="452" /></a></div>
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<br /></div>
Andi Usman Pharmahttp://www.blogger.com/profile/00236524553139613509noreply@blogger.com1tag:blogger.com,1999:blog-4997010120417470107.post-28168350732819316352013-01-26T17:33:00.001-08:002013-01-30T07:30:04.090-08:00Proses Pembuatan Tablet/Kaplet Biasa<br />
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<span lang="EN-US"> </span><span style="font-family: 'Times New Roman', serif; line-height: 150%; text-indent: -21.3pt;"> </span><span style="font-family: 'Times New Roman', serif; line-height: 150%; text-indent: -21.3pt;">Menurut FI edisi IV, tablet adalah sediaan padat
yang mengandung bahan obat dengan atau tanpa bahan pengisi. Secara umum tablet
dibuat dengan 3 cara atau metode, yaitu granulasi basah (</span><i style="font-family: 'Times New Roman', serif; line-height: 150%; text-indent: -21.3pt;">wet granulation</i><span style="font-family: 'Times New Roman', serif; line-height: 150%; text-indent: -21.3pt;">),
granulasi kering (</span><i style="font-family: 'Times New Roman', serif; line-height: 150%; text-indent: -21.3pt;">dry granulation</i><span style="font-family: 'Times New Roman', serif; line-height: 150%; text-indent: -21.3pt;">) dan kempa langsung (</span><i style="font-family: 'Times New Roman', serif; line-height: 150%; text-indent: -21.3pt;">direct
compression</i><span style="font-family: 'Times New Roman', serif; line-height: 150%; text-indent: -21.3pt;">).</span></div>
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<span style="font-family: "Times New Roman","serif"; mso-ansi-language: IN;"> Komponen
yang terdapat dalam tablet antara lain bahan aktif dan bahan tambahan. Maksud
bahan tambahan adalah bahan yang digunakan untuk memperbaiki sifat-sifat bahan
yang akan ditablet. Macam bahan tambahan :<o:p></o:p></span></div>
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<!--[if !supportLists]--><span style="font-family: "Times New Roman","serif"; mso-ansi-language: IN;">a.<span style="font-family: 'Times New Roman'; font-size: 7pt; line-height: normal;">
</span></span><!--[endif]--><span style="font-family: "Times New Roman","serif"; mso-ansi-language: IN;">Bahan pengisi (<i>filler</i>)<o:p></o:p></span></div>
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<!--[if !supportLists]--><span style="font-family: "Times New Roman","serif"; mso-ansi-language: IN;">b.<span style="font-family: 'Times New Roman'; font-size: 7pt; line-height: normal;">
</span></span><!--[endif]--><span style="font-family: "Times New Roman","serif"; mso-ansi-language: IN;">Bahan pengikat (<i>binder</i>)<o:p></o:p></span></div>
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<!--[if !supportLists]--><span style="font-family: "Times New Roman","serif"; mso-ansi-language: IN;">c.<span style="font-family: 'Times New Roman'; font-size: 7pt; line-height: normal;">
</span></span><!--[endif]--><span style="font-family: "Times New Roman","serif"; mso-ansi-language: IN;">Bahan penghancur (<i>disintegrants</i>)<o:p></o:p></span></div>
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<!--[if !supportLists]--><span style="font-family: "Times New Roman","serif"; mso-ansi-language: IN;">d.<span style="font-family: 'Times New Roman'; font-size: 7pt; line-height: normal;">
</span></span><!--[endif]--><span style="font-family: "Times New Roman","serif"; mso-ansi-language: IN;">Bahan pelicin (<i>lubricant</i>)<o:p></o:p></span></div>
<div class="MsoNormal" style="line-height: 150%; margin-left: 54.0pt; mso-list: l1 level1 lfo2; tab-stops: 35.45pt; text-align: justify; text-indent: -32.7pt;">
<!--[if !supportLists]--><span style="font-family: "Times New Roman","serif"; mso-ansi-language: IN;">e.<span style="font-family: 'Times New Roman'; font-size: 7pt; line-height: normal;">
</span></span><!--[endif]--><span style="font-family: "Times New Roman","serif"; mso-ansi-language: IN;">Zat pewarna (<i>coloring agent</i>)<o:p></o:p></span></div>
<div class="MsoNormal" style="line-height: 150%; margin-left: 54.0pt; mso-list: l1 level1 lfo2; tab-stops: 35.45pt; text-align: justify; text-indent: -32.7pt;">
<!--[if !supportLists]--><span style="font-family: "Times New Roman","serif"; mso-ansi-language: IN; mso-bidi-font-style: italic;">f.<span style="font-family: 'Times New Roman'; font-size: 7pt; line-height: normal;">
</span></span><!--[endif]--><i><span style="font-family: "Times New Roman","serif"; mso-ansi-language: IN;">Glidant</span></i><span style="font-family: "Times New Roman","serif"; mso-ansi-language: IN;"> dan <i>Antiadherent<o:p></o:p></i></span></div>
<div class="MsoNormal" style="line-height: 150%; margin-left: 54.0pt; mso-list: l1 level1 lfo2; tab-stops: 35.45pt; text-align: justify; text-indent: -32.7pt;">
<!--[if !supportLists]--><span style="font-family: "Times New Roman","serif"; mso-ansi-language: IN;">g.<span style="font-family: 'Times New Roman'; font-size: 7pt; line-height: normal;">
</span></span><!--[endif]--><span style="font-family: "Times New Roman","serif"; mso-ansi-language: IN;">Pemanis (<i>flavoring agent</i>), khususnya untuk tablet
kunyah.</span></div>
<div class="MsoNormal" style="line-height: 150%; margin-left: 54.0pt; mso-list: l1 level1 lfo2; tab-stops: 35.45pt; text-align: justify; text-indent: -32.7pt;">
<span style="font-family: 'Times New Roman', serif; line-height: 150%; text-indent: 1cm;"><br /></span></div>
<div class="MsoNormal" style="line-height: 150%; tab-stops: 49.65pt; text-align: justify; text-indent: 1.0cm;">
<span style="font-family: Times New Roman, serif; line-height: 150%; text-indent: 1cm;">Metode kempa langsung digunakan apabila semua bahan pembuat obat memiliki sifat alir dan kompaktibilitas yang baik. Metode ini paling sederhana, bahan di<i>mixing</i> kemudian langsung di cetak.Sedangkan jika menggunakan metode granulasi digunakan untuk bahan yang sifat alir dan kompaktibilitasnya tidak baik.</span><span style="font-family: 'Times New Roman', serif; line-height: 150%; text-indent: 1cm;"> Tujuan granulasi adalah untuk meningkatkan aliran campuran dan atau
kemampuan kempa. Metode granulasi kering digunakan untuk bahan yang tidak tahan pemanasan. </span></div>
<div class="MsoNormal" style="line-height: 150%; tab-stops: 49.65pt; text-align: justify; text-indent: 1.0cm;">
<span style="font-family: 'Times New Roman', serif; line-height: 150%; text-indent: 1cm;">Pada metode granulasi basah diawali dari pengambilan bahan baku dari gudang
yang telah diluluskan oleh bagian QC. Pengeluaran bahan baku dari gudang untuk
proses produksi harus disertai dokumen </span><i style="font-family: 'Times New Roman', serif; line-height: 150%; text-indent: 1cm;">Raw Material Requisition</i><span style="font-family: 'Times New Roman', serif; line-height: 150%; text-indent: 1cm;">. Bahan
baku yang telah diambil dari gudang ditimbang di dalam ruang timbang. Bahan
yang telah ditimbang diberilabel / penandaan dan dimasukkan ke ruang produk
antara untuk menunggu proses granulasi dalam pembuatan tablet.</span></div>
<div class="MsoNormal" style="line-height: 150%; tab-stops: 1.0cm 49.65pt; text-align: justify; text-indent: 1.0cm;">
<span style="font-family: "Times New Roman","serif"; mso-ansi-language: IN;">Proses selanjutnya adalah proses <i>mixing</i><i>, </i>hingga terbentuk massa granul basah. Massa
granul basah diayak. Granul basah
yang diperoleh dikeringkan dengan <i>fluid bed dryer </i>(FBD) hingga diperoleh
granul kering. Pada proses ini dilakukan cek kadar air oleh bagian IPC. Granul
yang diperoleh dan telah kering dicampur dengan bahan penghancur dan bahan
pelicin di dalam<i> mixer</i>, pada proses ini dilakukan pemeriksaan
keseragaman kadar zat aktif terhadap granul oleh bagian analisa (laboratorium
analisa). Granul selanjutnya dicetak. <o:p></o:p></span></div>
<div class="MsoBodyText2" style="line-height: 150%; margin-bottom: .0001pt; margin-bottom: 0cm; tab-stops: 49.65pt; text-align: justify; text-indent: 1.0cm;">
Tablet yang dihasilkan diperiksa oleh bagian IPC
meliputi pemeriksaan keseragaman bobot, kekerasan, kerapuhan, dan waktu hancur
Sedangkan untuk pengujian disolusi dan kadar zat aktif dilakukan oleh bagian
analisa. Setelah tablet lulus uji, dimasukkan pada pengemasan primer yang
meliputi proses <i>stripping.</i> Dilakukan pemeriksaan kebocoran strip oleh bagian IPC. Selanjutnya dikemas
sekunder dan diperiksa penampilan, kelengkapan, dan penandaan oleh QC. Jika
lulus uji, dimasukkan ke dalam gudang produk jadi. Secara skematis alur proses
pembuatan tablet dengan metode granulasi basah disajikan dalam gambar berikut.<o:p></o:p></div>
<div align="center" class="MsoNormal" style="line-height: 150%; margin-left: 21.3pt; tab-stops: 1.0cm; text-align: center; text-indent: -21.3pt;">
<br /></div>
<div class="separator" style="clear: both; text-align: center;">
<a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjipRxZrZuWLN78OxhD06fI7ALnR0_EMcbgqqVThlcRc2AI0lq-I2Wg9cDuqUGjruIYupFcQENnJ9YFBVEMXwMFf326PJKP17BLhRRa65x6Y_pQhVYYYjzYxywiu19FzqfHjgmAl3Ewl54/s1600/mtode+granulasi+basah.jpg" imageanchor="1" style="margin-left: 1em; margin-right: 1em;"><img border="0" height="640" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjipRxZrZuWLN78OxhD06fI7ALnR0_EMcbgqqVThlcRc2AI0lq-I2Wg9cDuqUGjruIYupFcQENnJ9YFBVEMXwMFf326PJKP17BLhRRa65x6Y_pQhVYYYjzYxywiu19FzqfHjgmAl3Ewl54/s640/mtode+granulasi+basah.jpg" style="cursor: move;" width="628" /></a></div>
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<br /></div>
<div class="MsoNormal" style="line-height: 150%; margin-left: 21.3pt; text-align: justify; text-indent: -21.3pt;">
<span style="font-family: 'Times New Roman', serif; font-size: 11pt; line-height: 150%;"> Perbedaan cara metode granulasi basah dan kering terletak pada cara pembuatan granulnya. Pada metode granulasi kering granul dibuat dengan cara di <i>slugging </i>(dikempa berulang-ulang).</span></div>
Andi Usman Pharmahttp://www.blogger.com/profile/00236524553139613509noreply@blogger.com1tag:blogger.com,1999:blog-4997010120417470107.post-91663490731603271762013-01-26T04:04:00.001-08:002013-01-26T04:08:39.347-08:00Klasifikasi Ruang Industri Farmasi<br />
<div class="MsoNormal" style="line-height: 150%; text-align: justify; text-autospace: ideograph-numeric; text-indent: 36.0pt;">
<span lang="EN-US">Ruangan di industri farmasi merupakan salah satu aspek yang harus dijaga kebersihannya. Untuk menghindari terjadinya kontaminasi silang antar produk maka ada beberapa hal yang perlu diperhatikan :</span></div>
<div class="MsoNormal" style="line-height: 150%; text-align: justify; text-autospace: ideograph-numeric; text-indent: 36.0pt;">
<span lang="EN-US">1. Permukaan ruangan harus kedap air, tidak terdapat sambungan atau retakan, tidak merupakan </span></div>
<div class="MsoNormal" style="line-height: 150%; text-align: left; text-indent: 36pt;">
<span lang="EN-US"> tempat pertumbuhan mikroba, mudah dibersihkan, bagian sudut dan tepi dinding dibuat </span></div>
<div class="MsoNormal" style="line-height: 150%; text-align: left; text-indent: 36pt;">
<span lang="EN-US"> melengkung.</span></div>
<div class="MsoNormal" style="line-height: 150%; text-align: justify; text-autospace: ideograph-numeric; text-indent: 36.0pt;">
<span lang="EN-US">2. Pipa saluran udara, listrik dipasang diatas langit-langit.</span></div>
<div class="MsoNormal" style="line-height: 150%; text-align: justify; text-autospace: ideograph-numeric; text-indent: 36.0pt;">
<span lang="EN-US">3. Lampu penerangan harus dipasang rata dengan langit-langit.</span></div>
<div class="MsoNormal" style="line-height: 150%; text-align: justify; text-autospace: ideograph-numeric; text-indent: 36.0pt;">
<span lang="EN-US">4. Tahan terhadap bahan pembersih.</span></div>
<div class="MsoNormal" style="line-height: 150%; text-align: justify; text-autospace: ideograph-numeric; text-indent: 36.0pt;">
<span lang="EN-US"><br /></span></div>
<div class="MsoNormal" style="line-height: 150%; text-align: justify; text-autospace: ideograph-numeric; text-indent: 36.0pt;">
<span lang="EN-US">Area pabrik dibagi menjadi 4 zona dimana masing-masing zona memiliki spesifikasi tertentu. Empat zona tersebut meliputi :<o:p></o:p></span></div>
<div class="MsoListParagraph" style="line-height: 150%; mso-list: l0 level1 lfo1; text-align: justify; text-autospace: ideograph-numeric; text-indent: -18.0pt;">
<!--[if !supportLists]--><b><i><span lang="EN-US">a.<span style="font-size: 7pt; font-style: normal; font-weight: normal; line-height: normal;">
</span></span></i></b><!--[endif]--><b><i><span lang="EN-US">Unclassified Area<o:p></o:p></span></i></b></div>
<div class="MsoNormal" style="line-height: 150%; text-align: justify; text-autospace: ideograph-numeric; text-indent: 36.0pt;">
<span lang="EN-US">Area ini merupakan area
yang tidak dikendalikan (<i>Unclassified
area</i>) tetapi untuk kepentingan tertentu ada beberapa parameter yang
dipantau. Termasuk didalamnya adalah laboratorium kimia (suhu terkontrol),
gudang (suhu terkontrol untuk <i>cold
storage</i> dan <i>cool room</i>), kantor,
kantin, ruang ganti dan ruang teknik. <o:p></o:p></span></div>
<div class="MsoListParagraph" style="line-height: 150%; mso-list: l0 level1 lfo1; text-align: justify; text-autospace: ideograph-numeric; text-indent: -18.0pt;">
<!--[if !supportLists]--><b><i><span lang="EN-US">b.<span style="font-size: 7pt; font-style: normal; font-weight: normal; line-height: normal;">
</span></span></i></b><!--[endif]--><b><i><span lang="EN-US">Black area<o:p></o:p></span></i></b></div>
<div class="MsoNormal" style="line-height: 150%; text-align: justify; text-autospace: ideograph-numeric; text-indent: 36.0pt;">
<span lang="EN-US">Area ini disebut juga
area kelas E. Ruangan ataupun area yang termasuk dalam kelas ini adalah koridor
yang menghubungkan ruang ganti dengan area produksi, area <i>staging</i> bahan kemas
dan ruang kemas sekunder. Setiap karyawan
wajib mengenakan sepatu dan pakaian black area (dengan penutup kepala)<o:p></o:p></span></div>
<div class="MsoListParagraph" style="line-height: 150%; mso-list: l0 level1 lfo1; text-align: justify; text-autospace: ideograph-numeric; text-indent: -18.0pt;">
<!--[if !supportLists]--><b><i><span lang="EN-US">c.<span style="font-size: 7pt; font-style: normal; font-weight: normal; line-height: normal;">
</span></span></i></b><!--[endif]--><b><i><span lang="EN-US">Grey area<o:p></o:p></span></i></b></div>
<div class="MsoNormal" style="line-height: 150%; text-align: justify; text-autospace: ideograph-numeric; text-indent: 36.0pt;">
<span lang="EN-US">Area ini disebut juga
area kelas D. Ruangan ataupun area yang masuk dalam kelas ini adalah ruang
produksi produk non steril, ruang
pengemasan primer, ruang timbang, laboratorium mikrobiologi (ruang preparasi,
ruang uji potensi dan inkubasi), ruang sampling di gudang. Setiap karyawan yang masuk ke area ini wajib mengenakan
<i>gowning</i> (pakaian dan sepatu grey). Antara <i>black</i> area dan grey area dibatasi
ruang ganti pakaian grey dan airlock.<o:p></o:p></span></div>
<div class="MsoListParagraph" style="line-height: 150%; mso-list: l0 level1 lfo1; text-align: justify; text-autospace: ideograph-numeric; text-indent: -18.0pt;">
<!--[if !supportLists]--><b><i><span lang="EN-US">d.<span style="font-size: 7pt; font-style: normal; font-weight: normal; line-height: normal;">
</span></span></i></b><!--[endif]--><b><i><span lang="EN-US">White area<o:p></o:p></span></i></b></div>
<div class="MsoNormal" style="line-height: 150%; text-align: justify; text-autospace: ideograph-numeric; text-indent: 36.0pt;">
<span lang="EN-US">Area ini disebut juga
area kelas C, B dan A (dibawah LAF). Ruangan yang masuk dalam area ini adalah
ruangan yang digunakan untuk penimbangan bahan baku produksi steril, ruang
mixing untuk produksi steril , <i>background </i>ruang <i>filling </i>, laboratorium mikrobiologi (ruang uji sterilitas). Setiap karyawan yang
akan memasuki area ini wajib mengenakan pakaian antistatik (pakaian dan sepatu
yang tidak melepas partikel). Antara <i>grey</i> area dan <i>white</i> area dipisahkan oleh
ruang ganti pakaian <i>white</i> dan <i>airlock</i>. <o:p></o:p></span></div>
<div class="MsoNormal" style="line-height: 150%; text-align: justify; text-autospace: ideograph-numeric; text-indent: 36.0pt;">
<span lang="EN-US"><i>Airlock </i>berfungsi
sebagai ruang penyangga antara 2 ruang dengan kelas kebersihan yang berbeda
untuk mencegah terjadinya kontaminasi dari ruangan dengan kelas kebersihan
lebih rendah ke ruang dengan kelas kebersihan lebih tinggi. Berdasarkan CPOB,
ruang diklasifikasikan menjadi kelas A, B, C, D dan E, dimana setiap kelas
memiliki persyaratan jumlah partikel, jumlah mikroba, tekanan, kelembaban udara
dan <i>air change rate</i>.<o:p></o:p></span></div>
<div class="MsoNormal" style="line-height: 150%; text-align: justify; text-autospace: ideograph-numeric; text-indent: 36.0pt;">
<br /></div>
<div class="MsoNormal" style="tab-stops: 72.0pt; text-align: justify; text-autospace: ideograph-numeric;">
<br /></div>
<div class="MsoListParagraph" style="margin-left: 0cm; mso-add-space: auto; text-align: justify; text-indent: 36.0pt;">
<b><span lang="EN-US" style="font-size: 11.0pt; mso-bidi-font-size: 12.0pt;">Tabel pembagian kelas ruangan berdasarkan jumlah partikel<o:p></o:p></span></b></div>
<table border="1" cellpadding="0" cellspacing="0" class="MsoNormalTable" style="border-collapse: collapse; border: none; mso-border-alt: solid windowtext .5pt; mso-border-insideh: .5pt solid windowtext; mso-border-insidev: .5pt solid windowtext; mso-padding-alt: 0cm 5.4pt 0cm 5.4pt; mso-yfti-tbllook: 1184;">
<thead>
<tr>
<td rowspan="3" style="border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 66.5pt;" width="89"><div align="center" class="MsoNormal" style="text-align: center; text-autospace: ideograph-numeric;">
<span lang="EN-US">Hygine
Zoning<o:p></o:p></span></div>
</td>
<td rowspan="3" style="border-left: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 58.4pt;" width="78"><div align="center" class="MsoNormal" style="text-align: center; text-autospace: ideograph-numeric;">
<span lang="EN-US">Kelas<o:p></o:p></span></div>
</td>
<td colspan="4" style="border-left: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 275.65pt;" width="368"><div align="center" class="MsoNormal" style="text-align: center; text-autospace: ideograph-numeric;">
<span lang="EN-US">Jumlah
partikel/m<sup>3</sup><o:p></o:p></span></div>
</td>
</tr>
<tr>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 137.05pt;" width="183"><div align="center" class="MsoNormal" style="text-align: center; text-autospace: ideograph-numeric;">
<span lang="EN-US">At rest<o:p></o:p></span></div>
</td>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 138.6pt;" width="185"><div align="center" class="MsoNormal" style="text-align: center; text-autospace: ideograph-numeric;">
<span lang="EN-US">In
Operational<o:p></o:p></span></div>
</td>
</tr>
<tr>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 75.6pt;" width="101"><div align="center" class="MsoNormal" style="text-align: center; text-autospace: ideograph-numeric;">
<span lang="EN-US">0,5 (µm)<o:p></o:p></span></div>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 61.45pt;" width="82"><div align="center" class="MsoNormal" style="text-align: center; text-autospace: ideograph-numeric;">
<span lang="EN-US">5,0 (µm)<o:p></o:p></span></div>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 72.25pt;" width="96"><div align="center" class="MsoNormal" style="text-align: center; text-autospace: ideograph-numeric;">
<span lang="EN-US">0,5 (µm)<o:p></o:p></span></div>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 66.35pt;" width="88"><div align="center" class="MsoNormal" style="text-align: center; text-autospace: ideograph-numeric;">
<span lang="EN-US">5,0 (µm)<o:p></o:p></span></div>
</td>
</tr>
</thead>
<tbody>
<tr>
<td style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 66.5pt;" valign="top" width="89"><div align="center" class="MsoNormal" style="text-align: center; text-autospace: ideograph-numeric;">
<span lang="EN-US">A<o:p></o:p></span></div>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 58.4pt;" valign="top" width="78"><div align="center" class="MsoNormal" style="text-align: center; text-autospace: ideograph-numeric;">
<span lang="EN-US">100<o:p></o:p></span></div>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 75.6pt;" valign="top" width="101"><div align="center" class="MsoNormal" style="text-align: center; text-autospace: ideograph-numeric;">
<span lang="EN-US">≤ 3.520<o:p></o:p></span></div>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 61.45pt;" valign="top" width="82"><div align="center" class="MsoNormal" style="text-align: center; text-autospace: ideograph-numeric;">
<span lang="EN-US">≤ 20<o:p></o:p></span></div>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 72.25pt;" valign="top" width="96"><div align="center" class="MsoNormal" style="text-align: center; text-autospace: ideograph-numeric;">
<span lang="EN-US">≤ 3.520<o:p></o:p></span></div>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 66.35pt;" valign="top" width="88"><div align="center" class="MsoNormal" style="text-align: center; text-autospace: ideograph-numeric;">
<span lang="EN-US">≤ 20<o:p></o:p></span></div>
</td>
</tr>
<tr>
<td style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 66.5pt;" valign="top" width="89"><div align="center" class="MsoNormal" style="text-align: center; text-autospace: ideograph-numeric;">
<span lang="EN-US">B<o:p></o:p></span></div>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 58.4pt;" valign="top" width="78"><div align="center" class="MsoNormal" style="text-align: center; text-autospace: ideograph-numeric;">
<span lang="EN-US">100<o:p></o:p></span></div>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 75.6pt;" valign="top" width="101"><div align="center" class="MsoNormal" style="text-align: center; text-autospace: ideograph-numeric;">
<span lang="EN-US">≤ 3.520<o:p></o:p></span></div>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 61.45pt;" valign="top" width="82"><div align="center" class="MsoNormal" style="text-align: center; text-autospace: ideograph-numeric;">
<span lang="EN-US">≤ 29<o:p></o:p></span></div>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 72.25pt;" valign="top" width="96"><div align="center" class="MsoNormal" style="text-align: center; text-autospace: ideograph-numeric;">
<span lang="EN-US">≤ 352.000<o:p></o:p></span></div>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 66.35pt;" valign="top" width="88"><div align="center" class="MsoNormal" style="text-align: center; text-autospace: ideograph-numeric;">
<span lang="EN-US">≤ 2.900<o:p></o:p></span></div>
</td>
</tr>
<tr>
<td style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 66.5pt;" valign="top" width="89"><div align="center" class="MsoNormal" style="text-align: center; text-autospace: ideograph-numeric;">
<span lang="EN-US">C<o:p></o:p></span></div>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 58.4pt;" valign="top" width="78"><div align="center" class="MsoNormal" style="text-align: center; text-autospace: ideograph-numeric;">
<span lang="EN-US">10.000<o:p></o:p></span></div>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 75.6pt;" valign="top" width="101"><div align="center" class="MsoNormal" style="text-align: center; text-autospace: ideograph-numeric;">
<span lang="EN-US">≤ 352.000<o:p></o:p></span></div>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 61.45pt;" valign="top" width="82"><div align="center" class="MsoNormal" style="text-align: center; text-autospace: ideograph-numeric;">
<span lang="EN-US">≤ 2.900<o:p></o:p></span></div>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 72.25pt;" valign="top" width="96"><div align="center" class="MsoNormal" style="text-align: center; text-autospace: ideograph-numeric;">
<span lang="EN-US">≤ 3.520.000<o:p></o:p></span></div>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 66.35pt;" valign="top" width="88"><div align="center" class="MsoNormal" style="text-align: center; text-autospace: ideograph-numeric;">
<span lang="EN-US">≤ 29.000<o:p></o:p></span></div>
</td>
</tr>
<tr>
<td style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 66.5pt;" valign="top" width="89"><div align="center" class="MsoNormal" style="text-align: center; text-autospace: ideograph-numeric;">
<span lang="EN-US">D<o:p></o:p></span></div>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 58.4pt;" valign="top" width="78"><div align="center" class="MsoNormal" style="text-align: center; text-autospace: ideograph-numeric;">
<span lang="EN-US">100.000<o:p></o:p></span></div>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 75.6pt;" valign="top" width="101"><div align="center" class="MsoNormal" style="text-align: center; text-autospace: ideograph-numeric;">
<span lang="EN-US">≤ 3.520.000<o:p></o:p></span></div>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 61.45pt;" valign="top" width="82"><div align="center" class="MsoNormal" style="text-align: center; text-autospace: ideograph-numeric;">
<span lang="EN-US">≤ 29.000<o:p></o:p></span></div>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 72.25pt;" valign="top" width="96"><div align="center" class="MsoNormal" style="text-align: center; text-autospace: ideograph-numeric;">
<span lang="EN-US">NS<o:p></o:p></span></div>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 66.35pt;" valign="top" width="88"><div align="center" class="MsoNormal" style="text-align: center; text-autospace: ideograph-numeric;">
<span lang="EN-US">NS<o:p></o:p></span></div>
</td>
</tr>
<tr>
<td style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 66.5pt;" valign="top" width="89"><div align="center" class="MsoNormal" style="text-align: center; text-autospace: ideograph-numeric;">
<span lang="EN-US">E1<o:p></o:p></span></div>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 58.4pt;" valign="top" width="78"><div align="center" class="MsoNormal" style="text-align: center; text-autospace: ideograph-numeric;">
<span lang="EN-US">UC<o:p></o:p></span></div>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 75.6pt;" valign="top" width="101"><div align="center" class="MsoNormal" style="text-align: center; text-autospace: ideograph-numeric;">
<span lang="EN-US">NS<o:p></o:p></span></div>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 61.45pt;" valign="top" width="82"><div align="center" class="MsoNormal" style="text-align: center; text-autospace: ideograph-numeric;">
<span lang="EN-US">NS<o:p></o:p></span></div>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 72.25pt;" valign="top" width="96"><div align="center" class="MsoNormal" style="text-align: center; text-autospace: ideograph-numeric;">
<span lang="EN-US">NS<o:p></o:p></span></div>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 66.35pt;" valign="top" width="88"><div align="center" class="MsoNormal" style="text-align: center; text-autospace: ideograph-numeric;">
<span lang="EN-US">NS<o:p></o:p></span></div>
</td>
</tr>
<tr>
<td style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 66.5pt;" valign="top" width="89"><div align="center" class="MsoNormal" style="text-align: center; text-autospace: ideograph-numeric;">
<span lang="EN-US">E2<o:p></o:p></span></div>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 58.4pt;" valign="top" width="78"><div align="center" class="MsoNormal" style="text-align: center; text-autospace: ideograph-numeric;">
<span lang="EN-US">UC<o:p></o:p></span></div>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 75.6pt;" valign="top" width="101"><div align="center" class="MsoNormal" style="text-align: center; text-autospace: ideograph-numeric;">
<span lang="EN-US">NS<o:p></o:p></span></div>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 61.45pt;" valign="top" width="82"><div align="center" class="MsoNormal" style="text-align: center; text-autospace: ideograph-numeric;">
<span lang="EN-US">NS<o:p></o:p></span></div>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 72.25pt;" valign="top" width="96"><div align="center" class="MsoNormal" style="text-align: center; text-autospace: ideograph-numeric;">
<span lang="EN-US">NS<o:p></o:p></span></div>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 66.35pt;" valign="top" width="88"><div align="center" class="MsoNormal" style="text-align: center; text-autospace: ideograph-numeric;">
<span lang="EN-US">NS<o:p></o:p></span></div>
</td>
</tr>
<tr>
<td style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 66.5pt;" valign="top" width="89"><div align="center" class="MsoNormal" style="text-align: center; text-autospace: ideograph-numeric;">
<span lang="EN-US">E3<o:p></o:p></span></div>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 58.4pt;" valign="top" width="78"><div align="center" class="MsoNormal" style="text-align: center; text-autospace: ideograph-numeric;">
<span lang="EN-US">UC<o:p></o:p></span></div>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 75.6pt;" valign="top" width="101"><div align="center" class="MsoNormal" style="text-align: center; text-autospace: ideograph-numeric;">
<span lang="EN-US">NS<o:p></o:p></span></div>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 61.45pt;" valign="top" width="82"><div align="center" class="MsoNormal" style="text-align: center; text-autospace: ideograph-numeric;">
<span lang="EN-US">NS<o:p></o:p></span></div>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 72.25pt;" valign="top" width="96"><div align="center" class="MsoNormal" style="text-align: center; text-autospace: ideograph-numeric;">
<span lang="EN-US">NS<o:p></o:p></span></div>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 66.35pt;" valign="top" width="88"><div align="center" class="MsoNormal" style="text-align: center; text-autospace: ideograph-numeric;">
<span lang="EN-US">NS<o:p></o:p></span></div>
</td>
</tr>
</tbody></table>
<div class="MsoNormal" style="tab-stops: 72.0pt; text-align: justify; text-autospace: ideograph-numeric;">
<br /></div>
<table border="1" cellpadding="0" cellspacing="0" class="MsoNormalTable" style="border-collapse: collapse; border: none; mso-border-alt: solid windowtext .5pt; mso-border-insideh: .5pt solid windowtext; mso-border-insidev: .5pt solid windowtext; mso-padding-alt: 0cm 5.4pt 0cm 5.4pt; mso-yfti-tbllook: 1184;">
<tbody>
<tr>
<td rowspan="2" style="border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 54.9pt;" width="73"><div align="center" class="MsoNormal" style="tab-stops: 72.0pt; text-align: center; text-autospace: ideograph-numeric;">
<span lang="EN-US">Hygine Zoning<o:p></o:p></span></div>
</td>
<td rowspan="2" style="border-left: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 63.0pt;" width="84"><div align="center" class="MsoNormal" style="tab-stops: 72.0pt; text-align: center; text-autospace: ideograph-numeric;">
<span lang="EN-US">Class<o:p></o:p></span></div>
</td>
<td colspan="3" style="border-left: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 289.65pt;" width="386"><div align="center" class="MsoNormal" style="tab-stops: 72.0pt; text-align: center; text-autospace: ideograph-numeric;">
<span lang="EN-US">Limit for Microbial contamination (In operation)<o:p></o:p></span></div>
</td>
</tr>
<tr>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 112.5pt;" valign="top" width="150"><div class="MsoNormal" style="tab-stops: 72.0pt; text-align: justify; text-autospace: ideograph-numeric;">
<span lang="EN-US">Air
sample (cfu/m<sup>3</sup>)<o:p></o:p></span></div>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 90.0pt;" valign="top" width="120"><div class="MsoNormal" style="tab-stops: 72.0pt; text-align: justify; text-autospace: ideograph-numeric;">
<span lang="EN-US">Settle
plates diam. 90mm (cfu/4 hours)<o:p></o:p></span></div>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 87.15pt;" valign="top" width="116"><div class="MsoNormal" style="tab-stops: 72.0pt; text-align: justify; text-autospace: ideograph-numeric;">
<span lang="EN-US">Glove
print, 5 fingers (cfu/glove)<o:p></o:p></span></div>
</td>
</tr>
<tr>
<td style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 54.9pt;" valign="top" width="73"><div align="center" class="MsoNormal" style="tab-stops: 72.0pt; text-align: center; text-autospace: ideograph-numeric;">
<span lang="EN-US">A<o:p></o:p></span></div>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 63.0pt;" valign="top" width="84"><div align="center" class="MsoNormal" style="tab-stops: 72.0pt; text-align: center; text-autospace: ideograph-numeric;">
<span lang="EN-US">100<o:p></o:p></span></div>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 112.5pt;" valign="top" width="150"><div align="center" class="MsoNormal" style="tab-stops: 72.0pt; text-align: center; text-autospace: ideograph-numeric;">
<span lang="EN-US">< 1<o:p></o:p></span></div>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 90.0pt;" valign="top" width="120"><div align="center" class="MsoNormal" style="tab-stops: 72.0pt; text-align: center; text-autospace: ideograph-numeric;">
<span lang="EN-US">< 1<o:p></o:p></span></div>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 87.15pt;" valign="top" width="116"><div align="center" class="MsoNormal" style="tab-stops: 72.0pt; text-align: center; text-autospace: ideograph-numeric;">
<span lang="EN-US">< 1<o:p></o:p></span></div>
</td>
</tr>
<tr>
<td style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 54.9pt;" valign="top" width="73"><div align="center" class="MsoNormal" style="tab-stops: 72.0pt; text-align: center; text-autospace: ideograph-numeric;">
<span lang="EN-US">B<o:p></o:p></span></div>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 63.0pt;" valign="top" width="84"><div align="center" class="MsoNormal" style="tab-stops: 72.0pt; text-align: center; text-autospace: ideograph-numeric;">
<span lang="EN-US">100<o:p></o:p></span></div>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 112.5pt;" valign="top" width="150"><div align="center" class="MsoNormal" style="tab-stops: 72.0pt; text-align: center; text-autospace: ideograph-numeric;">
<span lang="EN-US">10<o:p></o:p></span></div>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 90.0pt;" valign="top" width="120"><div align="center" class="MsoNormal" style="tab-stops: 72.0pt; text-align: center; text-autospace: ideograph-numeric;">
<span lang="EN-US">5<o:p></o:p></span></div>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 87.15pt;" valign="top" width="116"><div align="center" class="MsoNormal" style="tab-stops: 72.0pt; text-align: center; text-autospace: ideograph-numeric;">
<span lang="EN-US">5<o:p></o:p></span></div>
</td>
</tr>
<tr>
<td style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 54.9pt;" valign="top" width="73"><div align="center" class="MsoNormal" style="tab-stops: 72.0pt; text-align: center; text-autospace: ideograph-numeric;">
<span lang="EN-US">C<o:p></o:p></span></div>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 63.0pt;" valign="top" width="84"><div align="center" class="MsoNormal" style="tab-stops: 72.0pt; text-align: center; text-autospace: ideograph-numeric;">
<span lang="EN-US">10.000<o:p></o:p></span></div>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 112.5pt;" valign="top" width="150"><div align="center" class="MsoNormal" style="tab-stops: 72.0pt; text-align: center; text-autospace: ideograph-numeric;">
<span lang="EN-US">100<o:p></o:p></span></div>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 90.0pt;" valign="top" width="120"><div align="center" class="MsoNormal" style="tab-stops: 72.0pt; text-align: center; text-autospace: ideograph-numeric;">
<span lang="EN-US">50<o:p></o:p></span></div>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 87.15pt;" valign="top" width="116"><div align="center" class="MsoNormal" style="tab-stops: 72.0pt; text-align: center; text-autospace: ideograph-numeric;">
<span lang="EN-US">NS<o:p></o:p></span></div>
</td>
</tr>
<tr>
<td style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 54.9pt;" valign="top" width="73"><div align="center" class="MsoNormal" style="tab-stops: 72.0pt; text-align: center; text-autospace: ideograph-numeric;">
<span lang="EN-US">D<o:p></o:p></span></div>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 63.0pt;" valign="top" width="84"><div align="center" class="MsoNormal" style="tab-stops: 72.0pt; text-align: center; text-autospace: ideograph-numeric;">
<span lang="EN-US">100.000<o:p></o:p></span></div>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 112.5pt;" valign="top" width="150"><div align="center" class="MsoNormal" style="tab-stops: 72.0pt; text-align: center; text-autospace: ideograph-numeric;">
<span lang="EN-US">200<o:p></o:p></span></div>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 90.0pt;" valign="top" width="120"><div align="center" class="MsoNormal" style="tab-stops: 72.0pt; text-align: center; text-autospace: ideograph-numeric;">
<span lang="EN-US">100<o:p></o:p></span></div>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 87.15pt;" valign="top" width="116"><div align="center" class="MsoNormal" style="tab-stops: 72.0pt; text-align: center; text-autospace: ideograph-numeric;">
<span lang="EN-US">NS<o:p></o:p></span></div>
</td>
</tr>
<tr>
<td style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 54.9pt;" valign="top" width="73"><div align="center" class="MsoNormal" style="tab-stops: 72.0pt; text-align: center; text-autospace: ideograph-numeric;">
<span lang="EN-US">E1<o:p></o:p></span></div>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 63.0pt;" valign="top" width="84"><div align="center" class="MsoNormal" style="tab-stops: 72.0pt; text-align: center; text-autospace: ideograph-numeric;">
<span lang="EN-US">UC<o:p></o:p></span></div>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 112.5pt;" valign="top" width="150"><div align="center" class="MsoNormal" style="tab-stops: 72.0pt; text-align: center; text-autospace: ideograph-numeric;">
<span lang="EN-US">NS<o:p></o:p></span></div>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 90.0pt;" valign="top" width="120"><div align="center" class="MsoNormal" style="tab-stops: 72.0pt; text-align: center; text-autospace: ideograph-numeric;">
<span lang="EN-US">NS<o:p></o:p></span></div>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 87.15pt;" valign="top" width="116"><div align="center" class="MsoNormal" style="tab-stops: 72.0pt; text-align: center; text-autospace: ideograph-numeric;">
<span lang="EN-US">NS<o:p></o:p></span></div>
</td>
</tr>
<tr>
<td style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 54.9pt;" valign="top" width="73"><div align="center" class="MsoNormal" style="tab-stops: 72.0pt; text-align: center; text-autospace: ideograph-numeric;">
<span lang="EN-US">E2<o:p></o:p></span></div>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 63.0pt;" valign="top" width="84"><div align="center" class="MsoNormal" style="tab-stops: 72.0pt; text-align: center; text-autospace: ideograph-numeric;">
<span lang="EN-US">UC<o:p></o:p></span></div>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 112.5pt;" valign="top" width="150"><div align="center" class="MsoNormal" style="tab-stops: 72.0pt; text-align: center; text-autospace: ideograph-numeric;">
<span lang="EN-US">NS<o:p></o:p></span></div>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 90.0pt;" valign="top" width="120"><div align="center" class="MsoNormal" style="tab-stops: 72.0pt; text-align: center; text-autospace: ideograph-numeric;">
<span lang="EN-US">NS<o:p></o:p></span></div>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 87.15pt;" valign="top" width="116"><div align="center" class="MsoNormal" style="tab-stops: 72.0pt; text-align: center; text-autospace: ideograph-numeric;">
<span lang="EN-US">NS<o:p></o:p></span></div>
</td>
</tr>
<tr>
<td style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 54.9pt;" valign="top" width="73"><div align="center" class="MsoNormal" style="tab-stops: 72.0pt; text-align: center; text-autospace: ideograph-numeric;">
<span lang="EN-US">E3<o:p></o:p></span></div>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 63.0pt;" valign="top" width="84"><div align="center" class="MsoNormal" style="tab-stops: 72.0pt; text-align: center; text-autospace: ideograph-numeric;">
<span lang="EN-US">UC<o:p></o:p></span></div>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 112.5pt;" valign="top" width="150"><div align="center" class="MsoNormal" style="tab-stops: 72.0pt; text-align: center; text-autospace: ideograph-numeric;">
<span lang="EN-US">NS<o:p></o:p></span></div>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 90.0pt;" valign="top" width="120"><div align="center" class="MsoNormal" style="tab-stops: 72.0pt; text-align: center; text-autospace: ideograph-numeric;">
<span lang="EN-US">NS<o:p></o:p></span></div>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 87.15pt;" valign="top" width="116"><div align="center" class="MsoNormal" style="tab-stops: 72.0pt; text-align: center; text-autospace: ideograph-numeric;">
<span lang="EN-US">NS<o:p></o:p></span></div>
</td>
</tr>
</tbody></table>
<div class="MsoNormal" style="tab-stops: 72.0pt; text-align: justify; text-autospace: ideograph-numeric;">
<span lang="EN-US">Keterangan : UC = Unclassified<o:p></o:p></span></div>
<div class="MsoNormal" style="tab-stops: 72.0pt; text-align: justify; text-autospace: ideograph-numeric;">
<span lang="EN-US"> NS
= No Specification<o:p></o:p></span><br />
<span lang="EN-US">Kondisi <i>at rest </i>yaitu kondisi dimana tidak ada operator yang beraktivitas di dalam ruangan, mesin dalam kondisi beroperasi, sedangkan kondisi <i>in operational</i> yaitu kondisi dimana ada operator yang sedang bekerja di dalam ruangan dan kondisi mesin sedang beroperasi.</span><br />
<span lang="EN-US"><br /></span>
<span lang="EN-US"><br /></span></div>
Andi Usman Pharmahttp://www.blogger.com/profile/00236524553139613509noreply@blogger.com12tag:blogger.com,1999:blog-4997010120417470107.post-26974166681084985862013-01-26T02:20:00.001-08:002013-01-30T07:33:44.850-08:00Gudang di Industri Farmasi<br />
<div class="MsoBodyTextIndent" style="line-height: 150%; margin-bottom: .0001pt; margin-bottom: 0cm; margin-left: 18.0pt; margin-right: 0cm; margin-top: 0cm; tab-stops: 28.05pt; text-align: justify; text-indent: 24.55pt;">
<span style="font-family: Times New Roman, serif;">Gudang di industri farmasi secara garis besar digunakan untuk menampung bahan awal (bahan baku dan bahan kemasa) dan produk jadi. Kondisi penyimpanan barang di gudang harus disesuaikan dengan sifat dari barang yang disimpan. Ada beberapa barang yang harus di simpan pada suhu tertentu. Alur keluar masuk barang menganut sistem FIFO (<i>First In First Out</i>) dan FEFO (<i>First Expired First Out</i>).</span></div>
<div class="MsoBodyTextIndent" style="line-height: 150%; margin-bottom: .0001pt; margin-bottom: 0cm; margin-left: 18.0pt; margin-right: 0cm; margin-top: 0cm; tab-stops: 28.05pt; text-align: justify; text-indent: 24.55pt;">
<span lang="X-NONE" style="font-family: "Times New Roman","serif";">Secara umum kegiatan yang dilakukan pada setiap
gudang adalah sebagai berikut :<o:p></o:p></span></div>
<div class="MsoBodyTextIndent" style="line-height: 150%; margin-bottom: .0001pt; margin-bottom: 0cm; margin-left: 21.3pt; margin-right: 0cm; margin-top: 0cm; mso-list: l2 level1 lfo3; tab-stops: 0cm; text-align: justify; text-indent: -21.3pt;">
<!--[if !supportLists]--><span lang="X-NONE" style="font-family: "Times New Roman","serif";">a.<span style="font-family: 'Times New Roman'; font-size: 7pt; line-height: normal;">
</span></span><!--[endif]--><span lang="X-NONE" style="font-family: "Times New Roman","serif";">Gudang
bahan baku<o:p></o:p></span></div>
<div class="MsoBodyTextIndent" style="line-height: 150%; margin-bottom: .0001pt; margin-bottom: 0cm; margin-left: 21.3pt; margin-right: 0cm; margin-top: 0cm; mso-list: l1 level1 lfo2; tab-stops: list 0cm left 14.2pt; text-align: justify; text-indent: 0cm;">
<!--[if !supportLists]--><span lang="X-NONE" style="font-family: "Times New Roman","serif";">1)<span style="font-family: 'Times New Roman'; font-size: 7pt; line-height: normal;">
</span></span><!--[endif]--><span lang="X-NONE" style="font-family: "Times New Roman","serif";">Menangani
penerimaan barang<o:p></o:p></span></div>
<div class="MsoBodyTextIndent" style="line-height: 150%; margin-bottom: .0001pt; margin-bottom: 0cm; margin-left: 35.45pt; margin-right: 0cm; margin-top: 0cm; mso-list: l1 level1 lfo2; tab-stops: list 0cm left 35.45pt; text-align: justify; text-indent: -14.15pt;">
<!--[if !supportLists]--><span lang="X-NONE" style="font-family: "Times New Roman","serif";">2)<span style="font-family: 'Times New Roman'; font-size: 7pt; line-height: normal;">
</span></span><!--[endif]--><span lang="X-NONE" style="font-family: "Times New Roman","serif";">Menangani
penyediaan dan penyerahan bahan baku untuk produksi sesuai dengan <i>material
requisition</i>.<o:p></o:p></span></div>
<div class="MsoBodyTextIndent" style="line-height: 150%; margin-bottom: .0001pt; margin-bottom: 0cm; margin-left: 35.45pt; margin-right: 0cm; margin-top: 0cm; mso-list: l1 level1 lfo2; tab-stops: list 0cm left 35.45pt; text-align: justify; text-indent: -14.15pt;">
<!--[if !supportLists]--><span lang="X-NONE" style="font-family: "Times New Roman","serif";">3)<span style="font-family: 'Times New Roman'; font-size: 7pt; line-height: normal;">
</span></span><!--[endif]--><span lang="X-NONE" style="font-family: "Times New Roman","serif";">Membuat
kartu persediaan bahan baku di gudang setiap hari, membuat laporan per minggu
dan per bulan yang diserahkan ke Departemen PPIC.<o:p></o:p></span></div>
<div class="MsoBodyTextIndent" style="line-height: 150%; margin-bottom: .0001pt; margin-bottom: 0cm; margin-left: 21.3pt; margin-right: 0cm; margin-top: 0cm; mso-list: l2 level1 lfo3; tab-stops: list 0cm left 14.2pt; text-align: justify; text-indent: -21.3pt;">
<!--[if !supportLists]--><span lang="X-NONE" style="font-family: "Times New Roman","serif";">b.<span style="font-family: 'Times New Roman'; font-size: 7pt; line-height: normal;">
</span></span><!--[endif]--><span lang="X-NONE" style="font-family: "Times New Roman","serif";">Gudang
bahan kemas<o:p></o:p></span></div>
<div class="MsoBodyTextIndent" style="line-height: 150%; margin-bottom: .0001pt; margin-bottom: 0cm; margin-left: 35.45pt; margin-right: 0cm; margin-top: 0cm; mso-list: l3 level1 lfo4; tab-stops: list 0cm left 35.45pt 67.5pt; text-align: justify; text-indent: -14.15pt;">
<!--[if !supportLists]--><span lang="SV" style="font-family: "Times New Roman","serif"; mso-ansi-language: SV;">1)<span style="font-family: 'Times New Roman'; font-size: 7pt; line-height: normal;">
</span></span><!--[endif]--><span lang="SV" style="font-family: "Times New Roman","serif"; mso-ansi-language: SV;">Menangani penerimaan barang kemas primer dan sekunder
sesuai dengan <i>material requisition</i>.<o:p></o:p></span></div>
<div class="MsoBodyTextIndent" style="line-height: 150%; margin-bottom: .0001pt; margin-bottom: 0cm; margin-left: 21.3pt; margin-right: 0cm; margin-top: 0cm; mso-list: l3 level1 lfo4; tab-stops: list 0cm left 14.2pt; text-align: justify; text-indent: 0cm;">
<!--[if !supportLists]--><span lang="X-NONE" style="font-family: "Times New Roman","serif";">2)<span style="font-family: 'Times New Roman'; font-size: 7pt; line-height: normal;">
</span></span><!--[endif]--><span lang="X-NONE" style="font-family: "Times New Roman","serif";">Membuat
rekonsiliasi bahan kemas.<o:p></o:p></span></div>
<div class="MsoBodyTextIndent" style="line-height: 150%; margin-bottom: .0001pt; margin-bottom: 0cm; margin-left: 35.45pt; margin-right: 0cm; margin-top: 0cm; mso-list: l3 level1 lfo4; tab-stops: list 0cm left 35.45pt; text-align: justify; text-indent: -14.15pt;">
<!--[if !supportLists]--><span lang="X-NONE" style="font-family: "Times New Roman","serif";">3)<span style="font-family: 'Times New Roman'; font-size: 7pt; line-height: normal;">
</span></span><!--[endif]--><span lang="X-NONE" style="font-family: "Times New Roman","serif";">Membuat
kartu persediaan bahan kemas di gudang setiap hari, membuat laporan per minggu
dan per bulan yang diserahkan ke departemen PPIC.<o:p></o:p></span></div>
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<!--[if !supportLists]--><span lang="X-NONE" style="font-family: "Times New Roman","serif";">c.<span style="font-family: 'Times New Roman'; font-size: 7pt; line-height: normal;">
</span></span><!--[endif]--><span lang="X-NONE" style="font-family: "Times New Roman","serif";">Gudang
obat jadi<o:p></o:p></span></div>
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<!--[if !supportLists]--><span lang="FI" style="font-family: "Times New Roman","serif"; mso-ansi-language: FI;">1)<span style="font-family: 'Times New Roman'; font-size: 7pt; line-height: normal;">
</span></span><!--[endif]--><span lang="FI" style="font-family: "Times New Roman","serif"; mso-ansi-language: FI;">Menangani proses penerimaan obat jadi dari bagian kemas
sekunder.<o:p></o:p></span></div>
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<!--[if !supportLists]--><span lang="FI" style="font-family: "Times New Roman","serif"; mso-ansi-language: FI;">2)<span style="font-family: 'Times New Roman'; font-size: 7pt; line-height: normal;">
</span></span><!--[endif]--><span lang="FI" style="font-family: "Times New Roman","serif"; mso-ansi-language: FI;">Menyiapkan dan mengirimkan obat jadi sesuai dengan order
penjualan dari Bagian <i>Marketing</i>.<o:p></o:p></span></div>
<div class="MsoBodyTextIndent" style="line-height: 150%; margin-bottom: .0001pt; margin-bottom: 0cm; margin-left: 35.45pt; margin-right: 0cm; margin-top: 0cm; mso-list: l0 level1 lfo1; tab-stops: list 0cm left 35.45pt; text-align: justify; text-indent: -18.0pt;">
<!--[if !supportLists]--><span lang="FI" style="font-family: "Times New Roman","serif"; mso-ansi-language: FI;">3)<span style="font-family: 'Times New Roman'; font-size: 7pt; line-height: normal;">
</span></span><!--[endif]--><span lang="FI" style="font-family: "Times New Roman","serif"; mso-ansi-language: FI;">Membuat kartu persediaan obat jadi per hari dan per bulan
yang diserahkan dan dipertanggung jawabkan ke Departemen PPIC.<o:p></o:p></span></div>
<div class="MsoBodyTextIndent" style="line-height: 150%; margin-bottom: .0001pt; margin-bottom: 0cm; margin-left: 35.45pt; margin-right: 0cm; margin-top: 0cm; mso-list: l0 level1 lfo1; tab-stops: list 0cm left 35.45pt; text-align: justify; text-indent: -18.0pt;">
<!--[if !supportLists]--><span lang="SV" style="font-family: "Times New Roman","serif"; mso-ansi-language: SV;">4)<span style="font-family: 'Times New Roman'; font-size: 7pt; line-height: normal;">
</span></span><!--[endif]--><span lang="SV" style="font-family: "Times New Roman","serif"; mso-ansi-language: SV;">Menangani retur obat dari konsumen.<o:p></o:p></span></div>
Andi Usman Pharmahttp://www.blogger.com/profile/00236524553139613509noreply@blogger.com1tag:blogger.com,1999:blog-4997010120417470107.post-53305617158361842902013-01-25T21:36:00.000-08:002013-01-30T07:38:06.989-08:00Cara Distribusi Obat yang Baik (CDOB)<br />
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<span style="font-family: "Times New Roman","serif"; font-size: 12.0pt;">Pedoman
<i>Good Distribution Practices for
Pharmaceutical Products</i> ini diterbitkan oleh WHO pada tahun 2005. Suatu jaringan distribusi harus menyelenggarakan
suatu sistem jaminan kualitas sehingga produk yang di distribusikan terjamin
mutu, khasiat, keamanan dan keabsahannya sampai ke tangan konsumen. Semua orang
dan perangkatnya bertanggungjawab dalam menanangi, menyimpan, dan
mendistribusikan obat. CDOB ini memberikan pedoman langkah-langkah dalam
menjaga kualitas produk dari semua aspek yang berkaitan dengan distribusi. <o:p></o:p></span></div>
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<br /></div>
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<span style="font-family: "Times New Roman","serif"; font-size: 12.0pt;">Pedoman ini terdiri dari :<o:p></o:p></span></div>
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<!--[if !supportLists]--><span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; mso-fareast-font-family: "Times New Roman";">1.<span style="font-family: 'Times New Roman'; font-size: 7pt;">
</span></span><!--[endif]--><span style="font-family: "Times New Roman","serif"; font-size: 12.0pt;">Organisasi
dan Management<o:p></o:p></span></div>
<div class="MsoListParagraphCxSpMiddle" style="margin-bottom: 0.0001pt; text-indent: -0.25in;">
<!--[if !supportLists]--><span style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT; mso-fareast-font-family: TimesNewRomanPSMT;">2.<span style="font-family: 'Times New Roman'; font-size: 7pt;">
</span></span><!--[endif]--><span style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT;">Personalia<o:p></o:p></span></div>
<div class="MsoListParagraphCxSpMiddle" style="margin-bottom: 0.0001pt; text-indent: -0.25in;">
<!--[if !supportLists]--><span style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT; mso-fareast-font-family: TimesNewRomanPSMT;">3.<span style="font-family: 'Times New Roman'; font-size: 7pt;">
</span></span><!--[endif]--><span style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT;">Quality management<o:p></o:p></span></div>
<div class="MsoListParagraphCxSpMiddle" style="margin-bottom: 0.0001pt; text-indent: -0.25in;">
<!--[if !supportLists]--><span style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT; mso-fareast-font-family: TimesNewRomanPSMT;">4.<span style="font-family: 'Times New Roman'; font-size: 7pt;">
</span></span><!--[endif]--><span style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT;">Bangunan, gudang dan penyimpanan<o:p></o:p></span></div>
<div class="MsoListParagraphCxSpMiddle" style="margin-bottom: 0.0001pt; text-indent: -0.25in;">
<!--[if !supportLists]--><span style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT; mso-fareast-font-family: TimesNewRomanPSMT;">5.<span style="font-family: 'Times New Roman'; font-size: 7pt;">
</span></span><!--[endif]--><span style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT;">Kendaraan dan peralatan <o:p></o:p></span></div>
<div class="MsoListParagraphCxSpMiddle" style="margin-bottom: 0.0001pt; text-indent: -0.25in;">
<!--[if !supportLists]--><span style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT; mso-fareast-font-family: TimesNewRomanPSMT;">6.<span style="font-family: 'Times New Roman'; font-size: 7pt;">
</span></span><!--[endif]--><span style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT;">Wadah dan penandaan wadah<o:p></o:p></span></div>
<div class="MsoListParagraphCxSpMiddle" style="margin-bottom: 0.0001pt; text-indent: -0.25in;">
<!--[if !supportLists]--><span style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT; mso-fareast-font-family: TimesNewRomanPSMT;">7.<span style="font-family: 'Times New Roman'; font-size: 7pt;">
</span></span><!--[endif]--><span style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT;">Pengiriman<o:p></o:p></span></div>
<div class="MsoListParagraphCxSpMiddle" style="margin-bottom: 0.0001pt; text-indent: -0.25in;">
<!--[if !supportLists]--><span style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT; mso-fareast-font-family: TimesNewRomanPSMT;">8.<span style="font-family: 'Times New Roman'; font-size: 7pt;">
</span></span><!--[endif]--><span style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT;">Transportasi dan produk dalam
pengangkutan<o:p></o:p></span></div>
<div class="MsoListParagraphCxSpMiddle" style="margin-bottom: 0.0001pt; text-indent: -0.25in;">
<!--[if !supportLists]--><span style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT; mso-fareast-font-family: TimesNewRomanPSMT;">9.<span style="font-family: 'Times New Roman'; font-size: 7pt;">
</span></span><!--[endif]--><span style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT;">Dokumentasi<o:p></o:p></span></div>
<div class="MsoListParagraphCxSpMiddle" style="margin-bottom: 0.0001pt; text-indent: -0.25in;">
<!--[if !supportLists]--><span style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT; mso-fareast-font-family: TimesNewRomanPSMT;">10.<span style="font-family: 'Times New Roman'; font-size: 7pt;"> </span></span><!--[endif]--><span style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT;">Pengemasan dan penandaan ulang<o:p></o:p></span></div>
<div class="MsoListParagraphCxSpMiddle" style="margin-bottom: 0.0001pt; text-indent: -0.25in;">
<!--[if !supportLists]--><span style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT; mso-fareast-font-family: TimesNewRomanPSMT;">11.<span style="font-family: 'Times New Roman'; font-size: 7pt;"> </span></span><!--[endif]--><span style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT;">Komplain<o:p></o:p></span></div>
<div class="MsoListParagraphCxSpMiddle" style="margin-bottom: 0.0001pt; text-indent: -0.25in;">
<!--[if !supportLists]--><span style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT; mso-fareast-font-family: TimesNewRomanPSMT;">12.<span style="font-family: 'Times New Roman'; font-size: 7pt;"> </span></span><!--[endif]--><span style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT;">Penarikan kembali<o:p></o:p></span></div>
<div class="MsoListParagraphCxSpMiddle" style="margin-bottom: 0.0001pt; text-indent: -0.25in;">
<!--[if !supportLists]--><span style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT; mso-fareast-font-family: TimesNewRomanPSMT;">13.<span style="font-family: 'Times New Roman'; font-size: 7pt;"> </span></span><!--[endif]--><span style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT;">Produk afkiran/ penolakan dan produk kembalian<o:p></o:p></span></div>
<div class="MsoListParagraphCxSpMiddle" style="margin-bottom: 0.0001pt; text-indent: -0.25in;">
<!--[if !supportLists]--><span style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT; mso-fareast-font-family: TimesNewRomanPSMT;">14.<span style="font-family: 'Times New Roman'; font-size: 7pt;"> </span></span><!--[endif]--><span style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT;">Produk tiruan<o:p></o:p></span></div>
<div class="MsoListParagraphCxSpMiddle" style="margin-bottom: 0.0001pt; text-indent: -0.25in;">
<!--[if !supportLists]--><span style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT; mso-fareast-font-family: TimesNewRomanPSMT;">15.<span style="font-family: 'Times New Roman'; font-size: 7pt;"> </span></span><!--[endif]--><span style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT;">Impor barang<o:p></o:p></span></div>
<div class="MsoListParagraphCxSpMiddle" style="margin-bottom: 0.0001pt; text-indent: -0.25in;">
<!--[if !supportLists]--><span style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT; mso-fareast-font-family: TimesNewRomanPSMT;">16.<span style="font-family: 'Times New Roman'; font-size: 7pt;"> </span></span><!--[endif]--><span style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT;">Kontrak<o:p></o:p></span></div>
<div class="MsoListParagraphCxSpLast" style="margin-bottom: 0.0001pt; text-indent: -0.25in;">
<!--[if !supportLists]--><span style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT; mso-fareast-font-family: TimesNewRomanPSMT;">17.<span style="font-family: 'Times New Roman'; font-size: 7pt;"> </span></span><!--[endif]--><span style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT;">Inspeksi diri<o:p></o:p></span></div>
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<br /></div>
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<span style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT;">Menurut BPOM RI tujuan utama pelakasanaan distribusi obat
yang baik adalah terselenggaranya suatu sistem jaminan kualitas oleh
distributor, yaitu :<o:p></o:p></span></div>
<div class="MsoListParagraphCxSpFirst" style="margin-bottom: 0.0001pt; text-align: justify; text-indent: -0.25in;">
<!--[if !supportLists]--><span style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT; mso-fareast-font-family: TimesNewRomanPSMT;">1.<span style="font-family: 'Times New Roman'; font-size: 7pt;">
</span></span><!--[endif]--><span style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT;">Menjamin penyebaran obat secara merata
dan teratur agar dapat diperoleh yang dibutuhkan pada saat diperlukan<o:p></o:p></span></div>
<div class="MsoListParagraphCxSpMiddle" style="margin-bottom: 0.0001pt; text-align: justify; text-indent: -0.25in;">
<!--[if !supportLists]--><span style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT; mso-fareast-font-family: TimesNewRomanPSMT;">2.<span style="font-family: 'Times New Roman'; font-size: 7pt;">
</span></span><!--[endif]--><span style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT;">Terlaksananya pengamanan lalu lintas
dan penggunaan obat tepat sampai kepada pihak yang membutuhkan secara sah untuk
melindungi masyarakat dari kesalahan penggunaan atau penyalahgunaan.<o:p></o:p></span></div>
<div class="MsoListParagraphCxSpMiddle" style="margin-bottom: 0.0001pt; text-align: justify; text-indent: -0.25in;">
<!--[if !supportLists]--><span style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT; mso-fareast-font-family: TimesNewRomanPSMT;">3.<span style="font-family: 'Times New Roman'; font-size: 7pt;">
</span></span><!--[endif]--><span style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT;">Menjamin keabsahan dan mutu obat agar
obat yang sampai ke tangan konsumen adalah obat yang efektif, aman dan dapat
digunakan sesuai tujuan penggunaannya.<o:p></o:p></span></div>
<div class="MsoListParagraphCxSpMiddle" style="margin-bottom: 0.0001pt; text-align: justify; text-indent: -0.25in;">
<!--[if !supportLists]--><span style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT; mso-fareast-font-family: TimesNewRomanPSMT;">4.<span style="font-family: 'Times New Roman'; font-size: 7pt;">
</span></span><!--[endif]--><span style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT;">Menjamin penyimpanan obat aman dan
sesuai kondisi yang dipersyarakan, termask selama transportasi.<o:p></o:p></span></div>
<div class="MsoListParagraphCxSpLast" style="margin-bottom: 0.0001pt; text-align: justify;">
<br /></div>
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<span style="font-family: "TimesNewRomanPSMT","serif"; font-size: 12.0pt; mso-bidi-font-family: TimesNewRomanPSMT;">Mengenai penjelasam isi CDOB akan kami jelaskan kemudian.<o:p></o:p></span></div>
Andi Usman Pharmahttp://www.blogger.com/profile/00236524553139613509noreply@blogger.com2tag:blogger.com,1999:blog-4997010120417470107.post-35017339632744098112013-01-16T06:30:00.001-08:002013-01-26T04:50:23.869-08:00Studi Stabilita<br />
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<span style="line-height: 150%;"><span style="font-size: small;"> </span><span style="font-family: Times, Times New Roman, serif;"> Mohon maaf cukup lama saya
tidak mengupdate isi dari blog ini. Jika ada teman-teman yang membutuhkan
literatur Insha Allah saya akan membantu. Pada kesempatan ini saya ingin
berbagi mengenai studi stabilita. Apa itu studi stabilita dan apa manfaatnya? Studi
stabilita merupakan <i>compliance </i><span style="font-size: small;">aspek
dalam jaminan kualitas suatu produk. </span></span></span><span style="font-family: Times, Times New Roman, serif;"><span lang="EN-US" style="line-height: 150%;">Pemastian mutu suatu obat tidak hanya mengandalkan
pada pelaksanaan pengujian tertentu saja; namun obat hendaklah dibuat dalam
kondisi yang dikendalikan atau dipantau secara cermat.</span><span style="line-height: 150%;"><o:p></o:p></span></span></div>
<div class="MsoNormal" style="line-height: 150%; margin-bottom: .0001pt; margin-bottom: 0cm; text-align: justify; text-indent: 36.0pt;">
<span style="font-family: Times, Times New Roman, serif; line-height: 150%;">Jadi studi stabilita
adalah serangkaian proses pengujian obat yang dilakukan pada periode dan jangka
waktu yang telah ditentukan dan terdokumentasi sehingga dapat membuktikan
apakah suatu obat stabil atau tidak pada kondisi penyimpanan yang telah
ditetapkan. <o:p></o:p></span></div>
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<span style="font-family: Times, Times New Roman, serif; line-height: 150%;">Pengujian stabilitas dilakukan pada
:<o:p></o:p></span></div>
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<span style="font-family: Times, Times New Roman, serif;"><span style="line-height: 150%;">a) </span><span style="line-height: 150%;">Produk baru
(bets pilot)<o:p></o:p></span></span></div>
<div class="MsoNormal" style="line-height: 150%; margin-bottom: .0001pt; margin-bottom: 0cm; tab-stops: 32.6pt; text-align: justify; text-autospace: ideograph-numeric;">
<span style="font-family: Times, Times New Roman, serif;"><span style="line-height: 150%;">b) </span><span style="line-height: 150%;">Kemasan baru
(berbeda dari standar yang telah ditetapkan)<o:p></o:p></span></span></div>
<div class="MsoNormal" style="line-height: 150%; margin-bottom: .0001pt; margin-bottom: 0cm; margin-left: 32.25pt; margin-right: 0cm; margin-top: 0cm; tab-stops: 32.6pt; text-align: justify; text-autospace: ideograph-numeric; text-indent: -32.25pt;">
<span style="font-family: Times, Times New Roman, serif;"><span style="line-height: 150%;">c)</span><span style="line-height: 150%;"> Perubahan
formula, metode pengolahan atau sumber atau pembuat bahan awal dan bahan kemas primer<o:p></o:p></span></span></div>
<div class="MsoNormal" style="line-height: 150%; margin-bottom: .0001pt; margin-bottom: 0cm; margin-left: 32.25pt; margin-right: 0cm; margin-top: 0cm; tab-stops: 32.6pt; text-align: justify; text-autospace: ideograph-numeric; text-indent: -32.25pt;">
<div style="text-align: left;">
<span style="font-family: Times, Times New Roman, serif;"><span style="line-height: 150%;">d) </span><span style="line-height: 150%;">Bets yang
diluluskan dengan pengecualian, misalnya bets yang sifatnya berbeda dari standar yang diolah ulang<o:p></o:p></span></span></div>
</div>
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<span style="font-family: Times, Times New Roman, serif;"><span style="line-height: 150%;">e) </span><span style="line-height: 150%;">Produk yang
beredar :<o:p></o:p></span></span></div>
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<!--[if !supportLists]--><span style="font-family: Times, Times New Roman, serif;"><span style="line-height: 150%;">1.<span style="line-height: normal;"> </span></span><!--[endif]--><span style="line-height: 150%;">Uji
stabilitas untuk produk beredar yang dilakukan minimal 1 bets dalam satu tahun,
asal didukung oleh data Pengkajian Produk Tahunan (<i>Annual Product Review</i>)
atau validasi retrospek</span><span style="line-height: 150%;">tif. <o:p></o:p></span></span></div>
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<!--[if !supportLists]--><span style="font-family: Times, Times New Roman, serif;"><span style="line-height: 150%;">2.<span style="line-height: normal;"> </span></span><!--[endif]--><span style="line-height: 150%;">Penyimpanan
sampel dilakukan pada suhu kamar, suhu yang dipersyaratkan dan hendaklah
dimonitor. <o:p></o:p></span></span></div>
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<span style="font-family: Times, Times New Roman, serif; line-height: 150%;">Apabila produk rekonstitusi,
dilakukan <i>in-use stability study</i> di periode akhir atau pada waktu
daluarsa produk tersebut<o:p></o:p></span></div>
<div class="MsoNormal" style="line-height: 150%; margin-bottom: .0001pt; margin-bottom: 0cm; text-align: justify;">
<span style="font-family: Times, Times New Roman, serif;"><br /></span></div>
<div class="MsoNormal" style="line-height: 150%; margin-bottom: .0001pt; margin-bottom: 0cm; text-align: justify;">
<span style="line-height: 150%;"><span style="font-family: Times, Times New Roman, serif;">Studi stabilita dapat dibagi menjadi 3
berdasarkan tujuannya:</span><span style="font-family: Times New Roman, serif; font-size: 12pt;"><o:p></o:p></span></span></div>
<table border="0" cellpadding="0" cellspacing="0" class="MsoNormalTable" style="border-collapse: collapse; margin-left: 2.75pt; mso-padding-alt: 2.75pt 2.75pt 2.75pt 2.75pt; mso-table-layout-alt: fixed; width: 643px;">
<tbody>
<tr>
<td colspan="4" style="background: #E6FF00; padding: 2.75pt 2.75pt 2.75pt 2.75pt; width: 17.0cm;" valign="top" width="643"><div class="TableContents" style="layout-grid-mode: char; line-height: 150%; text-align: justify;">
<span lang="EN-US">Summary
of the different types of stability testing<o:p></o:p></span></div>
<div class="TableContents" style="line-height: 150%; text-align: justify;">
<span lang="EN-US">(exemplarily for a
new registration of human medicinal product)<o:p></o:p></span></div>
</td>
</tr>
<tr>
<td style="background: #FFCC99; padding: 2.75pt 2.75pt 2.75pt 2.75pt; width: 99.3pt;" valign="top" width="132"><div class="TableContents" style="layout-grid-mode: char; line-height: 150%; text-align: justify;">
<span lang="EN-US">Study
Type<o:p></o:p></span></div>
</td>
<td style="background: #FFFFCC; padding: 2.75pt 2.75pt 2.75pt 2.75pt; width: 113.35pt;" valign="top" width="151"><div class="TableContents" style="layout-grid-mode: char; line-height: 150%; text-align: justify;">
<span lang="EN-US">R&D
Study<o:p></o:p></span></div>
</td>
<td style="background: #FFFFCC; padding: 2.75pt 2.75pt 2.75pt 2.75pt; width: 134.65pt;" valign="top" width="180"><div class="TableContents" style="layout-grid-mode: char; line-height: 150%; text-align: justify;">
<span lang="EN-US">Follow-up
(commitment study)<o:p></o:p></span></div>
</td>
<td style="background: #FFFFCC; padding: 2.75pt 2.75pt 2.75pt 2.75pt; width: 134.65pt;" valign="top" width="180"><div class="TableContents" style="layout-grid-mode: char; line-height: 150%; text-align: justify;">
<span lang="EN-US">On-going
study<o:p></o:p></span></div>
</td>
</tr>
<tr>
<td style="background: #FFCC99; padding: 2.75pt 2.75pt 2.75pt 2.75pt; width: 99.3pt;" valign="top" width="132"><div class="TableContents" style="layout-grid-mode: char; line-height: 150%; text-align: justify;">
<span lang="EN-US">Time
point<o:p></o:p></span></div>
</td>
<td style="padding: 2.75pt 2.75pt 2.75pt 2.75pt; width: 113.35pt;" valign="top" width="151"><div class="TableContents" style="layout-grid-mode: char; line-height: 150%; text-align: justify;">
<span lang="EN-US">Before
registration<o:p></o:p></span></div>
</td>
<td style="padding: 2.75pt 2.75pt 2.75pt 2.75pt; width: 134.65pt;" valign="top" width="180"><div class="TableContents" style="layout-grid-mode: char; line-height: 150%; text-align: justify;">
<span lang="EN-US">After
submission of the dossier<o:p></o:p></span></div>
</td>
<td style="padding: 2.75pt 2.75pt 2.75pt 2.75pt; width: 134.65pt;" valign="top" width="180"><div class="TableContents" style="layout-grid-mode: char; line-height: 150%; text-align: justify;">
<span lang="EN-US">After
registration and marketing<o:p></o:p></span></div>
</td>
</tr>
<tr>
<td style="background: #FFCC99; padding: 2.75pt 2.75pt 2.75pt 2.75pt; width: 99.3pt;" valign="top" width="132"><div class="TableContents" style="layout-grid-mode: char; line-height: 150%; text-align: justify;">
<span lang="EN-US">Aim of
the study<o:p></o:p></span></div>
</td>
<td style="padding: 2.75pt 2.75pt 2.75pt 2.75pt; width: 113.35pt;" valign="top" width="151"><div class="TableContents" style="layout-grid-mode: char; line-height: 150%; text-align: justify;">
<span lang="EN-US">Setting
self-life, storage conditions and spesifications<o:p></o:p></span></div>
</td>
<td style="padding: 2.75pt 2.75pt 2.75pt 2.75pt; width: 134.65pt;" valign="top" width="180"><div class="TableContents" style="layout-grid-mode: char; line-height: 150%; text-align: justify;">
<span lang="EN-US">Verify
registration data<o:p></o:p></span></div>
</td>
<td style="padding: 2.75pt 2.75pt 2.75pt 2.75pt; width: 134.65pt;" valign="top" width="180"><div class="TableContents" style="layout-grid-mode: char; line-height: 150%; text-align: justify;">
<span lang="EN-US">Proof
registration are still valid<o:p></o:p></span></div>
</td>
</tr>
<tr>
<td style="background: #FFCC99; padding: 2.75pt 2.75pt 2.75pt 2.75pt; width: 99.3pt;" valign="top" width="132"><div class="TableContents" style="layout-grid-mode: char; line-height: 150%; text-align: justify;">
<span lang="EN-US">Background<o:p></o:p></span></div>
</td>
<td style="padding: 2.75pt 2.75pt 2.75pt 2.75pt; width: 113.35pt;" valign="top" width="151"><div class="TableContents" style="layout-grid-mode: char; line-height: 150%; text-align: justify;">
<span lang="EN-US">Registration
procedures, guidelines for stability testing (for example: ICH)<o:p></o:p></span></div>
<div class="TableContents" style="layout-grid-mode: char; line-height: 150%; text-align: justify;">
<br /></div>
</td>
<td style="padding: 2.75pt 2.75pt 2.75pt 2.75pt; width: 134.65pt;" valign="top" width="180"><div class="TableContents" style="layout-grid-mode: char; line-height: 150%; text-align: justify;">
<span lang="EN-US">Registration
procuedures, guidelines for stability testing<o:p></o:p></span></div>
</td>
<td style="padding: 2.75pt 2.75pt 2.75pt 2.75pt; width: 134.65pt;" valign="top" width="180"><div class="TableContents" style="layout-grid-mode: char; line-height: 150%; text-align: justify;">
<span lang="EN-US">EU-<st1:stockticker w:st="on">GMP</st1:stockticker> guidelines<o:p></o:p></span></div>
</td>
</tr>
<tr>
<td style="background: #FFCC99; padding: 2.75pt 2.75pt 2.75pt 2.75pt; width: 99.3pt;" valign="top" width="132"><div class="TableContents" style="layout-grid-mode: char; line-height: 150%; text-align: justify;">
<span lang="EN-US">Extent<o:p></o:p></span></div>
</td>
<td style="padding: 2.75pt 2.75pt 2.75pt 2.75pt; width: 113.35pt;" valign="top" width="151"><div class="TableContents" style="layout-grid-mode: char; line-height: 150%; text-align: justify;">
<span lang="EN-US">Two
pillot- or production-scale batches of the finished product. If 'critical',
for example when known as unstable, three batches<br />
<!--[if !supportLineBreakNewLine]--><br />
<!--[endif]--><o:p></o:p></span></div>
<div class="TableContents" style="line-height: 150%; text-align: justify;">
<br /></div>
</td>
<td style="padding: 2.75pt 2.75pt 2.75pt 2.75pt; width: 134.65pt;" valign="top" width="180"><div class="TableContents" style="layout-grid-mode: char; line-height: 150%; text-align: justify;">
<span lang="EN-US">Production-scale,
three batches of finished product <o:p></o:p></span></div>
</td>
<td style="padding: 2.75pt 2.75pt 2.75pt 2.75pt; width: 134.65pt;" valign="top" width="180"><div class="TableContents" style="layout-grid-mode: char; line-height: 150%; text-align: justify;">
<span lang="EN-US">Continous;
one batch<o:p></o:p></span></div>
<div class="TableContents" style="line-height: 150%; text-align: justify;">
<span lang="EN-US">-per year<o:p></o:p></span></div>
<div class="TableContents" style="line-height: 150%; text-align: justify;">
<span lang="EN-US">-each product <o:p></o:p></span></div>
<div class="TableContents" style="line-height: 150%; text-align: justify;">
<span lang="EN-US">-each strenght<o:p></o:p></span></div>
<div class="TableContents" style="line-height: 150%; text-align: justify;">
<span lang="EN-US">-each package<o:p></o:p></span></div>
</td>
</tr>
<tr>
<td style="background: #FFCC99; padding: 2.75pt 2.75pt 2.75pt 2.75pt; width: 99.3pt;" valign="top" width="132"><div class="TableContents" style="layout-grid-mode: char; line-height: 150%; text-align: justify;">
<span lang="EN-US">Competent
authority<o:p></o:p></span></div>
</td>
<td style="padding: 2.75pt 2.75pt 2.75pt 2.75pt; width: 113.35pt;" valign="top" width="151"><div class="TableContents" style="layout-grid-mode: char; line-height: 150%; text-align: justify;">
<span lang="EN-US">Regulatory
agency<o:p></o:p></span></div>
</td>
<td style="padding: 2.75pt 2.75pt 2.75pt 2.75pt; width: 134.65pt;" valign="top" width="180"><div class="TableContents" style="layout-grid-mode: char; line-height: 150%; text-align: justify;">
<span lang="EN-US">Regulatory
agency<o:p></o:p></span></div>
</td>
<td style="padding: 2.75pt 2.75pt 2.75pt 2.75pt; width: 134.65pt;" valign="top" width="180"><div class="TableContents" style="layout-grid-mode: char; line-height: 150%; text-align: justify;">
<span lang="EN-US">National
<st1:stockticker w:st="on">GMP</st1:stockticker> surveillance – Regulatory
agency or health authorities<o:p></o:p></span></div>
</td>
</tr>
</tbody></table>
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<br /></div>
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<span style="font-family: Times, Times New Roman, serif;"><span style="line-height: 150%;"> </span><b style="line-height: 150%;"><span lang="EN-US">Kondisi Penyimpanan (<i>Storage
Condition</i>), Periode dan Interval Pengujian Sample</span></b></span></div>
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<span style="font-family: Times, Times New Roman, serif;"><br /></span></div>
<div class="MsoNormal" style="line-height: 150%; margin-bottom: .0001pt; margin-bottom: 0cm; margin-right: .55pt; mso-margin-top-alt: auto;">
<span style="font-family: Times, Times New Roman, serif;"><span lang="EN-US" style="line-height: 150%;">Sampel untuk <i>long term condition </i>disimpan
berdasarkan pada area dimana produk akan dipasarkan. Berdasarkan hal tersebut,
terdapat 5 <i>climatic zone</i>, yaitu :</span><span lang="EN-US" style="line-height: 150%;"><o:p></o:p></span></span><br />
<span lang="EN-US" style="font-family: Times, Times New Roman, serif; line-height: 150%;"><br /></span></div>
<div class="MsoNormal" style="line-height: 150%; margin-bottom: .0001pt; margin-bottom: 0cm; margin-right: .55pt; mso-margin-top-alt: auto;">
<br /></div>
<div align="right">
<table border="1" cellpadding="0" cellspacing="0" class="MsoNormalTable" style="border: outset black 1.0pt; mso-border-alt: outset black .75pt; mso-cellspacing: 0cm; mso-padding-alt: 3.0pt 3.0pt 3.0pt 3.0pt; mso-yfti-tbllook: 1184; width: 550px;">
<tbody>
<tr>
<td style="border: inset black 1.0pt; mso-border-alt: inset black .75pt; padding: 3.0pt 3.0pt 3.0pt 3.0pt; width: 46.5pt;" width="62"><div align="center" class="MsoNormal" style="line-height: 150%; margin-bottom: .0001pt; margin-bottom: 0cm; mso-margin-top-alt: auto; text-align: center;">
<b><i><span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 150%; mso-fareast-font-family: "Times New Roman"; mso-fareast-language: IN;">Climatic
Zone</span></i></b><span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 150%; mso-fareast-font-family: "Times New Roman"; mso-fareast-language: IN;"><o:p></o:p></span></div>
</td>
<td style="border: inset black 1.0pt; mso-border-alt: inset black .75pt; padding: 3.0pt 3.0pt 3.0pt 3.0pt; width: 129.75pt;" width="173"><div align="center" class="MsoNormal" style="line-height: 150%; margin-bottom: .0001pt; margin-bottom: 0cm; mso-margin-top-alt: auto; text-align: center;">
<b><span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 150%; mso-fareast-font-family: "Times New Roman"; mso-fareast-language: IN;">Definisi</span></b><span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 150%; mso-fareast-font-family: "Times New Roman"; mso-fareast-language: IN;"><o:p></o:p></span></div>
</td>
<td style="border: inset black 1.0pt; mso-border-alt: inset black .75pt; padding: 3.0pt 3.0pt 3.0pt 3.0pt; width: 111.0pt;" width="148"><div align="center" class="MsoNormal" style="line-height: 150%; margin-bottom: .0001pt; margin-bottom: 0cm; mso-margin-top-alt: auto; text-align: center;">
<b><span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 150%; mso-fareast-font-family: "Times New Roman"; mso-fareast-language: IN;">Kriteria <sup>(*)</sup></span></b><span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 150%; mso-fareast-font-family: "Times New Roman"; mso-fareast-language: IN;"><o:p></o:p></span></div>
</td>
<td style="border: inset black 1.0pt; mso-border-alt: inset black .75pt; padding: 3.0pt 3.0pt 3.0pt 3.0pt; width: 99.75pt;" width="133"><div align="center" class="MsoNormal" style="line-height: 150%; margin-bottom: .0001pt; margin-bottom: 0cm; mso-margin-top-alt: auto; text-align: center;">
<b><span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 150%; mso-fareast-font-family: "Times New Roman"; mso-fareast-language: IN;">Kondisi
Penyimpanan (<i>Long Term Study</i>)</span></b><span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 150%; mso-fareast-font-family: "Times New Roman"; mso-fareast-language: IN;"><o:p></o:p></span></div>
</td>
</tr>
<tr>
<td style="border: inset black 1.0pt; mso-border-alt: inset black .75pt; padding: 3.0pt 3.0pt 3.0pt 3.0pt; width: 46.5pt;" width="62"><div align="center" class="MsoNormal" style="line-height: 150%; margin-bottom: .0001pt; margin-bottom: 0cm; mso-margin-top-alt: auto; text-align: center;">
<span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 150%; mso-fareast-font-family: "Times New Roman"; mso-fareast-language: IN;">I<o:p></o:p></span></div>
</td>
<td style="border: inset black 1.0pt; mso-border-alt: inset black .75pt; padding: 3.0pt 3.0pt 3.0pt 3.0pt; width: 129.75pt;" width="173"><div align="center" class="MsoNormal" style="line-height: 150%; margin-bottom: .0001pt; margin-bottom: 0cm; mso-margin-top-alt: auto; text-align: center;">
<i><span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 150%; mso-fareast-font-family: "Times New Roman"; mso-fareast-language: IN;">Temperature
Climate</span></i><span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 150%; mso-fareast-font-family: "Times New Roman"; mso-fareast-language: IN;"><o:p></o:p></span></div>
</td>
<td style="border: inset black 1.0pt; mso-border-alt: inset black .75pt; padding: 3.0pt 3.0pt 3.0pt 3.0pt; width: 111.0pt;" width="148"><div align="center" class="MsoNormal" style="line-height: 150%; margin-bottom: .0001pt; margin-bottom: 0cm; margin-left: -3.4pt; mso-margin-top-alt: auto; text-align: center;">
<span style="font-family: 'Times New Roman', serif; font-size: 12pt; line-height: 150%;">≤</span><span lang="EN-US" style="font-family: 'Times New Roman', serif; font-size: 12pt; line-height: 150%;">15<sup>o</sup>C
/ ≤11 hPa</span><span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 150%; mso-fareast-font-family: "Times New Roman"; mso-fareast-language: IN;"><o:p></o:p></span></div>
</td>
<td style="border: inset black 1.0pt; mso-border-alt: inset black .75pt; padding: 3.0pt 3.0pt 3.0pt 3.0pt; width: 99.75pt;" width="133"><div align="center" class="MsoNormal" style="line-height: 150%; margin-bottom: .0001pt; margin-bottom: 0cm; mso-margin-top-alt: auto; text-align: center;">
<span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 150%; mso-fareast-font-family: "Times New Roman"; mso-fareast-language: IN;">21</span><sup><span lang="EN-US" style="font-family: 'Times New Roman', serif; font-size: 12pt; line-height: 150%;">o</span></sup><span lang="EN-US" style="font-family: 'Times New Roman', serif; font-size: 12pt; line-height: 150%;">C / 45% RH</span><span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 150%; mso-fareast-font-family: "Times New Roman"; mso-fareast-language: IN;"><o:p></o:p></span></div>
</td>
</tr>
<tr>
<td style="border: inset black 1.0pt; mso-border-alt: inset black .75pt; padding: 3.0pt 3.0pt 3.0pt 3.0pt; width: 46.5pt;" width="62"><div align="center" class="MsoNormal" style="line-height: 150%; margin-bottom: .0001pt; margin-bottom: 0cm; mso-margin-top-alt: auto; text-align: center;">
<span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 150%; mso-fareast-font-family: "Times New Roman"; mso-fareast-language: IN;">II<o:p></o:p></span></div>
</td>
<td style="border: inset black 1.0pt; mso-border-alt: inset black .75pt; padding: 3.0pt 3.0pt 3.0pt 3.0pt; width: 129.75pt;" width="173"><div align="center" class="MsoNormal" style="line-height: 150%; margin-bottom: .0001pt; margin-bottom: 0cm; mso-margin-top-alt: auto; text-align: center;">
<i><span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 150%; mso-fareast-font-family: "Times New Roman"; mso-fareast-language: IN;">Subtropical
& Mediterranean Climate</span></i><span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 150%; mso-fareast-font-family: "Times New Roman"; mso-fareast-language: IN;"><o:p></o:p></span></div>
</td>
<td style="border: inset black 1.0pt; mso-border-alt: inset black .75pt; padding: 3.0pt 3.0pt 3.0pt 3.0pt; width: 111.0pt;" width="148"><div align="center" class="MsoNormal" style="line-height: 150%; margin-bottom: .0001pt; margin-bottom: 0cm; margin-left: -3.4pt; mso-margin-top-alt: auto; text-align: center;">
<span lang="EN-US" style="font-family: 'Times New Roman', serif; font-size: 12pt; line-height: 150%;">>15<sup>o</sup>C
to 22<sup>o</sup>C / </span><span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 150%; mso-fareast-font-family: "Times New Roman"; mso-fareast-language: IN;"><o:p></o:p></span></div>
<div align="center" class="MsoNormal" style="line-height: 150%; margin-bottom: .0001pt; margin-bottom: 0cm; margin-left: -3.4pt; mso-margin-top-alt: auto; text-align: center;">
<span lang="EN-US" style="font-family: 'Times New Roman', serif; font-size: 12pt; line-height: 150%;">>11 to 18 hPa</span><span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 150%; mso-fareast-font-family: "Times New Roman"; mso-fareast-language: IN;"><o:p></o:p></span></div>
</td>
<td style="border: inset black 1.0pt; mso-border-alt: inset black .75pt; padding: 3.0pt 3.0pt 3.0pt 3.0pt; width: 99.75pt;" width="133"><div align="center" class="MsoNormal" style="line-height: 150%; margin-bottom: .0001pt; margin-bottom: 0cm; mso-margin-top-alt: auto; text-align: center;">
<span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 150%; mso-fareast-font-family: "Times New Roman"; mso-fareast-language: IN;">25</span><sup><span lang="EN-US" style="font-family: 'Times New Roman', serif; font-size: 12pt; line-height: 150%;">o</span></sup><span lang="EN-US" style="font-family: 'Times New Roman', serif; font-size: 12pt; line-height: 150%;">C / 60% RH</span><span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 150%; mso-fareast-font-family: "Times New Roman"; mso-fareast-language: IN;"><o:p></o:p></span></div>
</td>
</tr>
<tr>
<td style="border: inset black 1.0pt; mso-border-alt: inset black .75pt; padding: 3.0pt 3.0pt 3.0pt 3.0pt; width: 46.5pt;" width="62"><div align="center" class="MsoNormal" style="line-height: 150%; margin-bottom: .0001pt; margin-bottom: 0cm; mso-margin-top-alt: auto; text-align: center;">
<span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 150%; mso-fareast-font-family: "Times New Roman"; mso-fareast-language: IN;">III<o:p></o:p></span></div>
</td>
<td style="border: inset black 1.0pt; mso-border-alt: inset black .75pt; padding: 3.0pt 3.0pt 3.0pt 3.0pt; width: 129.75pt;" width="173"><div align="center" class="MsoNormal" style="line-height: 150%; margin-bottom: .0001pt; margin-bottom: 0cm; mso-margin-top-alt: auto; text-align: center;">
<i><span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 150%; mso-fareast-font-family: "Times New Roman"; mso-fareast-language: IN;">Hot &
Dry Climate</span></i><span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 150%; mso-fareast-font-family: "Times New Roman"; mso-fareast-language: IN;"><o:p></o:p></span></div>
</td>
<td style="border: inset black 1.0pt; mso-border-alt: inset black .75pt; padding: 3.0pt 3.0pt 3.0pt 3.0pt; width: 111.0pt;" width="148"><div align="center" class="MsoNormal" style="line-height: 150%; margin-bottom: .0001pt; margin-bottom: 0cm; mso-margin-top-alt: auto; text-align: center;">
<a href="http://www.blogger.com/blogger.g?blogID=4997010120417470107" name="DDE_LINK"></a><span lang="EN-US" style="font-family: 'Times New Roman', serif; font-size: 12pt; line-height: 150%;">>22<sup>o</sup>C
/ ≤15 hPa</span><span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 150%; mso-fareast-font-family: "Times New Roman"; mso-fareast-language: IN;"><o:p></o:p></span></div>
</td>
<td style="border: inset black 1.0pt; mso-border-alt: inset black .75pt; padding: 3.0pt 3.0pt 3.0pt 3.0pt; width: 99.75pt;" width="133"><div align="center" class="MsoNormal" style="line-height: 150%; margin-bottom: .0001pt; margin-bottom: 0cm; mso-margin-top-alt: auto; text-align: center;">
<span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 150%; mso-fareast-font-family: "Times New Roman"; mso-fareast-language: IN;">30</span><sup><span lang="EN-US" style="font-family: 'Times New Roman', serif; font-size: 12pt; line-height: 150%;">o</span></sup><span lang="EN-US" style="font-family: 'Times New Roman', serif; font-size: 12pt; line-height: 150%;">C / 35% RH</span><span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 150%; mso-fareast-font-family: "Times New Roman"; mso-fareast-language: IN;"><o:p></o:p></span></div>
</td>
</tr>
<tr>
<td style="border: inset black 1.0pt; mso-border-alt: inset black .75pt; padding: 3.0pt 3.0pt 3.0pt 3.0pt; width: 46.5pt;" width="62"><div align="center" class="MsoNormal" style="line-height: 150%; margin-bottom: .0001pt; margin-bottom: 0cm; mso-margin-top-alt: auto; text-align: center;">
<span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 150%; mso-fareast-font-family: "Times New Roman"; mso-fareast-language: IN;">IVA<o:p></o:p></span></div>
</td>
<td style="border: inset black 1.0pt; mso-border-alt: inset black .75pt; padding: 3.0pt 3.0pt 3.0pt 3.0pt; width: 129.75pt;" width="173"><div align="center" class="MsoNormal" style="line-height: 150%; margin-bottom: .0001pt; margin-bottom: 0cm; mso-margin-top-alt: auto; text-align: center;">
<i><span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 150%; mso-fareast-font-family: "Times New Roman"; mso-fareast-language: IN;">Hot &
Humid Climate</span></i><span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 150%; mso-fareast-font-family: "Times New Roman"; mso-fareast-language: IN;"><o:p></o:p></span></div>
</td>
<td style="border: inset black 1.0pt; mso-border-alt: inset black .75pt; padding: 3.0pt 3.0pt 3.0pt 3.0pt; width: 111.0pt;" width="148"><div align="center" class="MsoNormal" style="line-height: 150%; margin-bottom: .0001pt; margin-bottom: 0cm; mso-margin-top-alt: auto; text-align: center;">
<a href="http://www.blogger.com/blogger.g?blogID=4997010120417470107" name="DDE_LINK3"></a><span lang="EN-US" style="font-family: 'Times New Roman', serif; font-size: 12pt; line-height: 150%;">>22<sup>o</sup>C/
>15 to 27 hPa</span><span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 150%; mso-fareast-font-family: "Times New Roman"; mso-fareast-language: IN;"><o:p></o:p></span></div>
</td>
<td style="border: inset black 1.0pt; mso-border-alt: inset black .75pt; padding: 3.0pt 3.0pt 3.0pt 3.0pt; width: 99.75pt;" width="133"><div align="center" class="MsoNormal" style="line-height: 150%; margin-bottom: .0001pt; margin-bottom: 0cm; mso-margin-top-alt: auto; text-align: center;">
<span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 150%; mso-fareast-font-family: "Times New Roman"; mso-fareast-language: IN;">30</span><sup><span lang="EN-US" style="font-family: 'Times New Roman', serif; font-size: 12pt; line-height: 150%;">o</span></sup><span lang="EN-US" style="font-family: 'Times New Roman', serif; font-size: 12pt; line-height: 150%;">C / 65% RH</span><span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 150%; mso-fareast-font-family: "Times New Roman"; mso-fareast-language: IN;"><o:p></o:p></span></div>
</td>
</tr>
<tr>
<td style="border: inset black 1.0pt; mso-border-alt: inset black .75pt; padding: 3.0pt 3.0pt 3.0pt 3.0pt; width: 46.5pt;" width="62"><div align="center" class="MsoNormal" style="line-height: 150%; margin-bottom: .0001pt; margin-bottom: 0cm; mso-margin-top-alt: auto; text-align: center;">
<span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 150%; mso-fareast-font-family: "Times New Roman"; mso-fareast-language: IN;">IVB<o:p></o:p></span></div>
</td>
<td style="border: inset black 1.0pt; mso-border-alt: inset black .75pt; padding: 3.0pt 3.0pt 3.0pt 3.0pt; width: 129.75pt;" width="173"><div align="center" class="MsoNormal" style="line-height: 150%; margin-bottom: .0001pt; margin-bottom: 0cm; mso-margin-top-alt: auto; text-align: center;">
<i><span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 150%; mso-fareast-font-family: "Times New Roman"; mso-fareast-language: IN;">Hot &
Very Humid Climate</span></i><span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 150%; mso-fareast-font-family: "Times New Roman"; mso-fareast-language: IN;"><o:p></o:p></span></div>
</td>
<td style="border: inset black 1.0pt; mso-border-alt: inset black .75pt; padding: 3.0pt 3.0pt 3.0pt 3.0pt; width: 111.0pt;" width="148"><div align="center" class="MsoNormal" style="line-height: 150%; margin-bottom: .0001pt; margin-bottom: 0cm; mso-margin-top-alt: auto; text-align: center;">
<a href="http://www.blogger.com/blogger.g?blogID=4997010120417470107" name="DDE_LINK4"></a><span lang="EN-US" style="font-family: 'Times New Roman', serif; font-size: 12pt; line-height: 150%;">>22<sup>o</sup>C
/ >27 hPa</span><span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 150%; mso-fareast-font-family: "Times New Roman"; mso-fareast-language: IN;"><o:p></o:p></span></div>
</td>
<td style="border: inset black 1.0pt; mso-border-alt: inset black .75pt; padding: 3.0pt 3.0pt 3.0pt 3.0pt; width: 99.75pt;" width="133"><div align="center" class="MsoNormal" style="line-height: 150%; margin-bottom: .0001pt; margin-bottom: 0cm; mso-margin-top-alt: auto; text-align: center;">
<span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 150%; mso-fareast-font-family: "Times New Roman"; mso-fareast-language: IN;">30</span><sup><span lang="EN-US" style="font-family: 'Times New Roman', serif; font-size: 12pt; line-height: 150%;">o</span></sup><span lang="EN-US" style="font-family: 'Times New Roman', serif; font-size: 12pt; line-height: 150%;">C / 75% RH</span><span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 150%; mso-fareast-font-family: "Times New Roman"; mso-fareast-language: IN;"><o:p></o:p></span></div>
</td>
</tr>
</tbody></table>
</div>
<div class="MsoNormal" style="line-height: 150%; margin-bottom: .0001pt; margin-bottom: 0cm; margin-right: .55pt; mso-margin-top-alt: auto;">
<span style="font-family: Times, Times New Roman, serif;"><b><sup><span lang="EN-US" style="line-height: 150%;">*) </span></sup></b><span lang="EN-US" style="line-height: 150%;">Keterangan pada kolom kriteria merupakan nilai yang diperoleh dari
rata-rata temperatur dalam setahun, yang diukur dari udara terbuka / rata-rata
tekanan parsial uap air dalam setahun.</span><span lang="EN-US" style="line-height: 150%;"><o:p></o:p></span></span></div>
<div class="MsoNormal" style="line-height: 150%; margin-bottom: .0001pt; margin-bottom: 0cm; margin-right: .55pt; mso-margin-top-alt: auto;">
<span style="font-family: Times, Times New Roman, serif;"><i><span style="line-height: 150%;">C</span></i><i><span lang="EN-US" style="line-height: 150%;">limatic zone </span></i><span lang="EN-US" style="line-height: 150%;">merupakan area / zona yang membagi dunia berdasarkan
kondisi iklim tahunan. Indonesia masuk ke dalam zona IVB.</span><span lang="EN-US" style="line-height: 150%;"><o:p></o:p></span></span></div>
<div class="MsoNormal" style="line-height: 150%; margin-bottom: .0001pt; margin-bottom: 0cm; margin-right: .55pt; mso-margin-top-alt: auto;">
<span style="font-family: Times, Times New Roman, serif;"><span style="line-height: 150%;">Desain studi stabilita ditentukan berdasarkan area dimana produk tsb akan dipasarkan.</span><span style="line-height: 150%;"> <span lang="EN-US">Kondisi penyimpanan untuk produk
zona III dan IV dengan label kondisi penyimpanan dibawah 30<sup>o</sup>C :</span></span></span><span lang="EN-US" style="font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 150%; mso-ansi-language: EN-US; mso-fareast-font-family: "Times New Roman"; mso-fareast-language: IN;"><o:p></o:p></span></div>
<table border="1" cellpadding="0" cellspacing="0" class="MsoNormalTable" style="border: outset black 1.0pt; margin-left: 36.0pt; mso-border-alt: outset black .75pt; mso-cellspacing: 0cm; mso-padding-alt: 3.0pt 3.0pt 3.0pt 3.0pt; mso-yfti-tbllook: 1184; width: 100%px;">
<tbody>
<tr>
<td style="border: inset black 1.0pt; mso-border-alt: inset black .75pt; padding: 3.0pt 3.0pt 3.0pt 3.0pt; width: 32.0%;" width="32%"><div align="center" class="MsoNormal" style="line-height: 150%; margin-bottom: .0001pt; margin-bottom: 0cm; mso-margin-top-alt: auto; text-align: center;">
<b><span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 150%; mso-fareast-font-family: "Times New Roman"; mso-fareast-language: IN;">Kondisi
Penyimpanan</span></b><span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 150%; mso-fareast-font-family: "Times New Roman"; mso-fareast-language: IN;"><o:p></o:p></span></div>
</td>
<td style="border: inset black 1.0pt; mso-border-alt: inset black .75pt; padding: 3.0pt 3.0pt 3.0pt 3.0pt; width: 22.0%;" width="22%"><div align="center" class="MsoNormal" style="line-height: 150%; margin-bottom: .0001pt; margin-bottom: 0cm; mso-margin-top-alt: auto; text-align: center;">
<b><span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 150%; mso-fareast-font-family: "Times New Roman"; mso-fareast-language: IN;">Periode
Pengujian</span></b><span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 150%; mso-fareast-font-family: "Times New Roman"; mso-fareast-language: IN;"><o:p></o:p></span></div>
</td>
<td style="border: inset black 1.0pt; mso-border-alt: inset black .75pt; padding: 3.0pt 3.0pt 3.0pt 3.0pt; width: 46.0%;" width="46%"><div align="center" class="MsoNormal" style="line-height: 150%; margin-bottom: .0001pt; margin-bottom: 0cm; mso-margin-top-alt: auto; text-align: center;">
<b><span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 150%; mso-fareast-font-family: "Times New Roman"; mso-fareast-language: IN;">Interval
Pengujian</span></b><span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 150%; mso-fareast-font-family: "Times New Roman"; mso-fareast-language: IN;"><o:p></o:p></span></div>
</td>
</tr>
<tr style="height: 42.0pt; mso-yfti-irow: 1;">
<td style="border: inset black 1.0pt; height: 42.0pt; mso-border-alt: inset black .75pt; padding: 3.0pt 3.0pt 3.0pt 3.0pt; width: 32.0%;" width="32%"><div align="center" class="MsoNormal" style="line-height: 150%; margin-bottom: .0001pt; margin-bottom: 0cm; mso-margin-top-alt: auto; text-align: center;">
<span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 150%; mso-fareast-font-family: "Times New Roman"; mso-fareast-language: IN;">3</span><span lang="EN-US" style="font-family: 'Times New Roman', serif; font-size: 12pt; line-height: 150%;">0<sup>o</sup>C±2<sup>o</sup>C / 75±5%RH</span><span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 150%; mso-fareast-font-family: "Times New Roman"; mso-fareast-language: IN;"><o:p></o:p></span></div>
</td>
<td style="border: inset black 1.0pt; height: 42.0pt; mso-border-alt: inset black .75pt; padding: 3.0pt 3.0pt 3.0pt 3.0pt; width: 22.0%;" width="22%"><div align="center" class="MsoNormal" style="line-height: 150%; margin-bottom: .0001pt; margin-bottom: 0cm; mso-margin-top-alt: auto; text-align: center;">
<span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 150%; mso-fareast-font-family: "Times New Roman"; mso-fareast-language: IN;">ED + 1<o:p></o:p></span></div>
<div align="center" class="MsoNormal" style="line-height: 150%; margin-bottom: .0001pt; margin-bottom: 0cm; mso-margin-top-alt: auto; text-align: center;">
<span lang="EN-US" style="font-family: 'Times New Roman', serif; font-size: 12pt; line-height: 150%;">(<i>Long Term</i>)</span><span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 150%; mso-fareast-font-family: "Times New Roman"; mso-fareast-language: IN;"><o:p></o:p></span></div>
</td>
<td style="border: inset black 1.0pt; height: 42.0pt; mso-border-alt: inset black .75pt; padding: 3.0pt 3.0pt 3.0pt 3.0pt; width: 46.0%;" width="46%"><ul type="disc">
<li class="MsoNormal" style="line-height: 150%; margin-bottom: .0001pt; margin-bottom: 0cm; mso-list: l4 level1 lfo3; mso-margin-top-alt: auto; tab-stops: list 36.0pt;"><span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 150%; mso-fareast-font-family: "Times New Roman"; mso-fareast-language: IN;">Tahun pertama setiap 3 bulan sekali.<o:p></o:p></span></li>
<li class="MsoNormal" style="line-height: 150%; margin-bottom: .0001pt; margin-bottom: 0cm; mso-list: l4 level1 lfo3; mso-margin-top-alt: auto; tab-stops: list 36.0pt;"><span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 150%; mso-fareast-font-family: "Times New Roman"; mso-fareast-language: IN;">Tahun kedua setiap 6 bulan sekali.<o:p></o:p></span></li>
<li class="MsoNormal" style="line-height: 150%; margin-bottom: .0001pt; margin-bottom: 0cm; mso-list: l4 level1 lfo3; mso-margin-top-alt: auto; tab-stops: list 36.0pt;"><span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 150%; mso-fareast-font-family: "Times New Roman"; mso-fareast-language: IN;">Tahun ketigas, sampai dengan ED+1 setiap 1
tahun sekali<o:p></o:p></span></li>
</ul>
</td>
</tr>
<tr>
<td style="border: inset black 1.0pt; mso-border-alt: inset black .75pt; padding: 3.0pt 3.0pt 3.0pt 3.0pt; width: 32.0%;" width="32%"><div align="center" class="MsoNormal" style="line-height: 150%; margin-bottom: .0001pt; margin-bottom: 0cm; mso-margin-top-alt: auto; text-align: center;">
<a href="http://www.blogger.com/blogger.g?blogID=4997010120417470107" name="DDE_LINK11"></a><span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 150%; mso-fareast-font-family: "Times New Roman"; mso-fareast-language: IN;">4</span><span lang="EN-US" style="font-family: 'Times New Roman', serif; font-size: 12pt; line-height: 150%;">0<sup>o</sup>C±2<sup>o</sup>C / 75±5%RH</span><span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 150%; mso-fareast-font-family: "Times New Roman"; mso-fareast-language: IN;"><o:p></o:p></span></div>
</td>
<td style="border: inset black 1.0pt; mso-border-alt: inset black .75pt; padding: 3.0pt 3.0pt 3.0pt 3.0pt; width: 22.0%;" width="22%"><div align="center" class="MsoNormal" style="line-height: 150%; margin-bottom: .0001pt; margin-bottom: 0cm; mso-margin-top-alt: auto; text-align: center;">
<span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 150%; mso-fareast-font-family: "Times New Roman"; mso-fareast-language: IN;">6 bulan<o:p></o:p></span></div>
<div align="center" class="MsoNormal" style="line-height: 150%; margin-bottom: .0001pt; margin-bottom: 0cm; mso-margin-top-alt: auto; text-align: center;">
<span lang="EN-US" style="font-family: 'Times New Roman', serif; font-size: 12pt; line-height: 150%;">(<i>Accelerated</i>)</span><span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 150%; mso-fareast-font-family: "Times New Roman"; mso-fareast-language: IN;"><o:p></o:p></span></div>
</td>
<td style="border: inset black 1.0pt; mso-border-alt: inset black .75pt; padding: 3.0pt 3.0pt 3.0pt 3.0pt; width: 46.0%;" width="46%"><div align="center" class="MsoNormal" style="line-height: 150%; margin-bottom: .0001pt; margin-bottom: 0cm; mso-margin-top-alt: auto; text-align: center;">
<span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 150%; mso-fareast-font-family: "Times New Roman"; mso-fareast-language: IN;">Bulan ke-3
dan 6<o:p></o:p></span></div>
</td>
</tr>
</tbody></table>
<div class="MsoNormal" style="line-height: 150%; margin-bottom: .0001pt; margin-bottom: 0cm; margin-right: .55pt; mso-margin-top-alt: auto;">
<br /></div>
<div class="MsoNormal" style="line-height: 150%; margin-bottom: .0001pt; margin-bottom: 0cm; margin-right: .55pt; mso-margin-top-alt: auto;">
<span lang="EN-US" style="font-family: Times, Times New Roman, serif; line-height: 150%;">Kondisi penyimpanan untuk zona I dan II:</span><span lang="EN-US" style="font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 150%; mso-ansi-language: EN-US; mso-fareast-font-family: "Times New Roman"; mso-fareast-language: IN;"><o:p></o:p></span></div>
<table border="1" cellpadding="0" cellspacing="0" class="MsoNormalTable" style="border: outset black 1.0pt; margin-left: 36.0pt; mso-border-alt: outset black .75pt; mso-cellspacing: 0cm; mso-padding-alt: 3.0pt 3.0pt 3.0pt 3.0pt; mso-yfti-tbllook: 1184; width: 100%px;">
<tbody>
<tr>
<td style="border: inset black 1.0pt; mso-border-alt: inset black .75pt; padding: 3.0pt 3.0pt 3.0pt 3.0pt; width: 32.0%;" width="32%"><div align="center" class="MsoNormal" style="line-height: 150%; margin-bottom: .0001pt; margin-bottom: 0cm; mso-margin-top-alt: auto; text-align: center;">
<b><span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 150%; mso-fareast-font-family: "Times New Roman"; mso-fareast-language: IN;">Kondisi
Penyimpanan</span></b><span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 150%; mso-fareast-font-family: "Times New Roman"; mso-fareast-language: IN;"><o:p></o:p></span></div>
</td>
<td style="border: inset black 1.0pt; mso-border-alt: inset black .75pt; padding: 3.0pt 3.0pt 3.0pt 3.0pt; width: 22.0%;" width="22%"><div align="center" class="MsoNormal" style="line-height: 150%; margin-bottom: .0001pt; margin-bottom: 0cm; mso-margin-top-alt: auto; text-align: center;">
<b><span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 150%; mso-fareast-font-family: "Times New Roman"; mso-fareast-language: IN;">Periode Pengujian</span></b><span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 150%; mso-fareast-font-family: "Times New Roman"; mso-fareast-language: IN;"><o:p></o:p></span></div>
</td>
<td style="border: inset black 1.0pt; mso-border-alt: inset black .75pt; padding: 3.0pt 3.0pt 3.0pt 3.0pt; width: 46.0%;" width="46%"><div align="center" class="MsoNormal" style="line-height: 150%; margin-bottom: .0001pt; margin-bottom: 0cm; mso-margin-top-alt: auto; text-align: center;">
<b><span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 150%; mso-fareast-font-family: "Times New Roman"; mso-fareast-language: IN;">Interval
Pengujian</span></b><span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 150%; mso-fareast-font-family: "Times New Roman"; mso-fareast-language: IN;"><o:p></o:p></span></div>
</td>
</tr>
<tr style="height: 42.0pt; mso-yfti-irow: 1;">
<td style="border: inset black 1.0pt; height: 42.0pt; mso-border-alt: inset black .75pt; padding: 3.0pt 3.0pt 3.0pt 3.0pt; width: 32.0%;" width="32%"><div align="center" class="MsoNormal" style="line-height: 150%; margin-bottom: .0001pt; margin-bottom: 0cm; mso-margin-top-alt: auto; text-align: center;">
<span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 150%; mso-fareast-font-family: "Times New Roman"; mso-fareast-language: IN;">25</span><sup><span lang="EN-US" style="font-family: 'Times New Roman', serif; font-size: 12pt; line-height: 150%;">o</span></sup><span lang="EN-US" style="font-family: 'Times New Roman', serif; font-size: 12pt; line-height: 150%;">C±2<sup>o</sup>C / 60±5%RH</span><span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 150%; mso-fareast-font-family: "Times New Roman"; mso-fareast-language: IN;"><o:p></o:p></span></div>
</td>
<td rowspan="2" style="border: inset black 1.0pt; height: 42.0pt; mso-border-alt: inset black .75pt; padding: 3.0pt 3.0pt 3.0pt 3.0pt; width: 22.0%;" width="22%"><div align="center" class="MsoNormal" style="line-height: 150%; margin-bottom: .0001pt; margin-bottom: 0cm; mso-margin-top-alt: auto; text-align: center;">
<br /></div>
<div align="center" class="MsoNormal" style="line-height: 150%; margin-bottom: .0001pt; margin-bottom: 0cm; mso-margin-top-alt: auto; text-align: center;">
<span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 150%; mso-fareast-font-family: "Times New Roman"; mso-fareast-language: IN;">ED + 1<o:p></o:p></span></div>
<div align="center" class="MsoNormal" style="line-height: 150%; margin-bottom: .0001pt; margin-bottom: 0cm; mso-margin-top-alt: auto; text-align: center;">
<span lang="EN-US" style="font-family: 'Times New Roman', serif; font-size: 12pt; line-height: 150%;">(<i>Long Term</i>)</span><span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 150%; mso-fareast-font-family: "Times New Roman"; mso-fareast-language: IN;"><o:p></o:p></span></div>
</td>
<td rowspan="2" style="border: inset black 1.0pt; height: 42.0pt; mso-border-alt: inset black .75pt; padding: 3.0pt 3.0pt 3.0pt 3.0pt; width: 46.0%;" width="46%"><ul type="disc">
<li class="MsoNormal" style="line-height: 150%; margin-bottom: .0001pt; margin-bottom: 0cm; mso-list: l3 level1 lfo4; mso-margin-top-alt: auto; tab-stops: list 36.0pt;"><span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 150%; mso-fareast-font-family: "Times New Roman"; mso-fareast-language: IN;">Tahun pertama setiap 3 bulan sekali.<o:p></o:p></span></li>
<li class="MsoNormal" style="line-height: 150%; margin-bottom: .0001pt; margin-bottom: 0cm; mso-list: l3 level1 lfo4; mso-margin-top-alt: auto; tab-stops: list 36.0pt;"><span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 150%; mso-fareast-font-family: "Times New Roman"; mso-fareast-language: IN;">Tahun kedua setiap 6 bulan sekali.<o:p></o:p></span></li>
<li class="MsoNormal" style="line-height: 150%; margin-bottom: .0001pt; margin-bottom: 0cm; mso-list: l3 level1 lfo4; mso-margin-top-alt: auto; tab-stops: list 36.0pt;"><span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 150%; mso-fareast-font-family: "Times New Roman"; mso-fareast-language: IN;">Tahun ketigas, sampai dengan ED+1 setiap 1
tahun sekali<o:p></o:p></span></li>
</ul>
</td>
</tr>
<tr style="height: 42.0pt; mso-yfti-irow: 2;">
<td style="border: inset black 1.0pt; height: 42.0pt; mso-border-alt: inset black .75pt; padding: 3.0pt 3.0pt 3.0pt 3.0pt; width: 32.0%;" width="32%"><div align="center" class="MsoNormal" style="line-height: 150%; margin-bottom: .0001pt; margin-bottom: 0cm; mso-margin-top-alt: auto; text-align: center;">
<span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 150%; mso-fareast-font-family: "Times New Roman"; mso-fareast-language: IN;">3</span><span lang="EN-US" style="font-family: 'Times New Roman', serif; font-size: 12pt; line-height: 150%;">0<sup>o</sup>C±2<sup>o</sup>C / 65±5%RH</span><span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 150%; mso-fareast-font-family: "Times New Roman"; mso-fareast-language: IN;"><o:p></o:p></span></div>
</td>
</tr>
<tr>
<td style="border: inset black 1.0pt; mso-border-alt: inset black .75pt; padding: 3.0pt 3.0pt 3.0pt 3.0pt; width: 32.0%;" width="32%"><div align="center" class="MsoNormal" style="line-height: 150%; margin-bottom: .0001pt; margin-bottom: 0cm; mso-margin-top-alt: auto; text-align: center;">
<a href="http://www.blogger.com/blogger.g?blogID=4997010120417470107" name="DDE_LINK112"></a><span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 150%; mso-fareast-font-family: "Times New Roman"; mso-fareast-language: IN;">4</span><span lang="EN-US" style="font-family: 'Times New Roman', serif; font-size: 12pt; line-height: 150%;">0<sup>o</sup>C±2<sup>o</sup>C / 75±5%RH</span><span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 150%; mso-fareast-font-family: "Times New Roman"; mso-fareast-language: IN;"><o:p></o:p></span></div>
</td>
<td style="border: inset black 1.0pt; mso-border-alt: inset black .75pt; padding: 3.0pt 3.0pt 3.0pt 3.0pt; width: 22.0%;" width="22%"><div align="center" class="MsoNormal" style="line-height: 150%; margin-bottom: .0001pt; margin-bottom: 0cm; mso-margin-top-alt: auto; text-align: center;">
<span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 150%; mso-fareast-font-family: "Times New Roman"; mso-fareast-language: IN;">6 bulan<o:p></o:p></span></div>
<div align="center" class="MsoNormal" style="line-height: 150%; margin-bottom: .0001pt; margin-bottom: 0cm; mso-margin-top-alt: auto; text-align: center;">
<span lang="EN-US" style="font-family: 'Times New Roman', serif; font-size: 12pt; line-height: 150%;">(<i>Accelerated</i>)</span><span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 150%; mso-fareast-font-family: "Times New Roman"; mso-fareast-language: IN;"><o:p></o:p></span></div>
</td>
<td style="border: inset black 1.0pt; mso-border-alt: inset black .75pt; padding: 3.0pt 3.0pt 3.0pt 3.0pt; width: 46.0%;" width="46%"><div align="center" class="MsoNormal" style="line-height: 150%; margin-bottom: .0001pt; margin-bottom: 0cm; mso-margin-top-alt: auto; text-align: center;">
<span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 150%; mso-fareast-font-family: "Times New Roman"; mso-fareast-language: IN;">Bulan ke-3
dan 6<o:p></o:p></span></div>
</td>
</tr>
</tbody></table>
<div class="MsoNormal" style="line-height: 150%; margin-bottom: .0001pt; margin-bottom: 0cm; margin-right: .55pt; mso-margin-top-alt: auto;">
<br /></div>
<div class="MsoNormal" style="line-height: 150%; margin-bottom: .0001pt; margin-bottom: 0cm; margin-right: .55pt; mso-margin-top-alt: auto;">
<span style="font-family: Times, Times New Roman, serif;"><span lang="EN-US" style="line-height: 150%;">Kondisi penyimpanan untuk produk dengan label kondisi
penyimpanan 2-8<sup>o</sup>C (almari pendingin) :</span><span lang="EN-US" style="line-height: 150%;"><o:p></o:p></span></span></div>
<div class="MsoNormal" style="line-height: 150%; margin-bottom: .0001pt; margin-bottom: 0cm; margin-right: .55pt; mso-margin-top-alt: auto;">
<br /></div>
<div align="right">
<table border="1" cellpadding="0" cellspacing="0" class="MsoNormalTable" style="border: outset black 1.0pt; mso-border-alt: outset black .75pt; mso-cellspacing: 0cm; mso-padding-alt: 3.0pt 3.0pt 3.0pt 3.0pt; mso-yfti-tbllook: 1184; width: 551px;">
<tbody>
<tr>
<td style="border: inset black 1.0pt; mso-border-alt: inset black .75pt; padding: 3.0pt 3.0pt 3.0pt 3.0pt; width: 123.75pt;" valign="top" width="165"><div align="center" class="MsoNormal" style="line-height: 150%; margin-bottom: .0001pt; margin-bottom: 0cm; mso-margin-top-alt: auto; text-align: center;">
<b><span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 150%; mso-fareast-font-family: "Times New Roman"; mso-fareast-language: IN;">Kondisi
Penyimpanan</span></b><span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 150%; mso-fareast-font-family: "Times New Roman"; mso-fareast-language: IN;"><o:p></o:p></span></div>
</td>
<td style="border: inset black 1.0pt; mso-border-alt: inset black .75pt; padding: 3.0pt 3.0pt 3.0pt 3.0pt; width: 85.5pt;" valign="top" width="114"><div align="center" class="MsoNormal" style="line-height: 150%; margin-bottom: .0001pt; margin-bottom: 0cm; mso-margin-top-alt: auto; text-align: center;">
<b><span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 150%; mso-fareast-font-family: "Times New Roman"; mso-fareast-language: IN;">Periode
Pengujian</span></b><span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 150%; mso-fareast-font-family: "Times New Roman"; mso-fareast-language: IN;"><o:p></o:p></span></div>
</td>
<td style="border: inset black 1.0pt; mso-border-alt: inset black .75pt; padding: 3.0pt 3.0pt 3.0pt 3.0pt; width: 184.5pt;" valign="top" width="246"><div align="center" class="MsoNormal" style="line-height: 150%; margin-bottom: .0001pt; margin-bottom: 0cm; mso-margin-top-alt: auto; text-align: center;">
<b><span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 150%; mso-fareast-font-family: "Times New Roman"; mso-fareast-language: IN;">Interval
Pengujian</span></b><span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 150%; mso-fareast-font-family: "Times New Roman"; mso-fareast-language: IN;"><o:p></o:p></span></div>
</td>
</tr>
<tr>
<td style="border: inset black 1.0pt; mso-border-alt: inset black .75pt; padding: 3.0pt 3.0pt 3.0pt 3.0pt; width: 123.75pt;" width="165"><div align="center" class="MsoNormal" style="line-height: 150%; margin-bottom: .0001pt; margin-bottom: 0cm; margin-left: -3.4pt; margin-right: .55pt; mso-margin-top-alt: auto; text-align: center;">
<span lang="EN-US" style="font-family: 'Times New Roman', serif; font-size: 12pt; line-height: 150%;">2 – 8 <sup>o</sup>C</span><span lang="EN-US" style="font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 150%; mso-ansi-language: EN-US; mso-fareast-font-family: "Times New Roman"; mso-fareast-language: IN;"><o:p></o:p></span></div>
</td>
<td style="border: inset black 1.0pt; mso-border-alt: inset black .75pt; padding: 3.0pt 3.0pt 3.0pt 3.0pt; width: 85.5pt;" width="114"><div align="center" class="MsoNormal" style="line-height: 150%; margin-bottom: .0001pt; margin-bottom: 0cm; mso-margin-top-alt: auto; text-align: center;">
<span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 150%; mso-fareast-font-family: "Times New Roman"; mso-fareast-language: IN;">ED + 1<o:p></o:p></span></div>
<div align="center" class="MsoNormal" style="line-height: 150%; margin-bottom: .0001pt; margin-bottom: 0cm; mso-margin-top-alt: auto; text-align: center;">
<span lang="EN-US" style="font-family: 'Times New Roman', serif; font-size: 12pt; line-height: 150%;">(<i>Long Term</i>)</span><span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 150%; mso-fareast-font-family: "Times New Roman"; mso-fareast-language: IN;"><o:p></o:p></span></div>
</td>
<td style="border: inset black 1.0pt; mso-border-alt: inset black .75pt; padding: 3.0pt 3.0pt 3.0pt 3.0pt; width: 184.5pt;" valign="top" width="246"><ul type="disc">
<li class="MsoNormal" style="line-height: 150%; margin-bottom: .0001pt; margin-bottom: 0cm; mso-list: l2 level1 lfo5; mso-margin-top-alt: auto; tab-stops: list 36.0pt;"><span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 150%; mso-fareast-font-family: "Times New Roman"; mso-fareast-language: IN;">Tahun pertama setiap 3 bulan sekali.<o:p></o:p></span></li>
<li class="MsoNormal" style="line-height: 150%; margin-bottom: .0001pt; margin-bottom: 0cm; mso-list: l2 level1 lfo5; mso-margin-top-alt: auto; tab-stops: list 36.0pt;"><span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 150%; mso-fareast-font-family: "Times New Roman"; mso-fareast-language: IN;">Tahun kedua setiap 6 bulan sekali.<o:p></o:p></span></li>
<li class="MsoNormal" style="line-height: 150%; margin-bottom: .0001pt; margin-bottom: 0cm; mso-list: l2 level1 lfo5; mso-margin-top-alt: auto; tab-stops: list 36.0pt;"><span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 150%; mso-fareast-font-family: "Times New Roman"; mso-fareast-language: IN;">Tahun ketigas, sampai dengan ED+1 setiap 1
tahun sekali<o:p></o:p></span></li>
</ul>
</td>
</tr>
<tr>
<td style="border: inset black 1.0pt; mso-border-alt: inset black .75pt; padding: 3.0pt 3.0pt 3.0pt 3.0pt; width: 123.75pt;" valign="top" width="165"><div align="center" class="MsoNormal" style="line-height: 150%; margin-bottom: .0001pt; margin-bottom: 0cm; mso-margin-top-alt: auto; text-align: center;">
<a href="http://www.blogger.com/blogger.g?blogID=4997010120417470107" name="DDE_LINK12"></a><span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 150%; mso-fareast-font-family: "Times New Roman"; mso-fareast-language: IN;">2</span><span lang="EN-US" style="font-family: 'Times New Roman', serif; font-size: 12pt; line-height: 150%;">5<sup>o</sup>C±2<sup>o</sup>C / 60±5%RH</span><span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 150%; mso-fareast-font-family: "Times New Roman"; mso-fareast-language: IN;"><o:p></o:p></span></div>
</td>
<td style="border: inset black 1.0pt; mso-border-alt: inset black .75pt; padding: 3.0pt 3.0pt 3.0pt 3.0pt; width: 85.5pt;" valign="top" width="114"><div align="center" class="MsoNormal" style="line-height: 150%; margin-bottom: .0001pt; margin-bottom: 0cm; mso-margin-top-alt: auto; text-align: center;">
<span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 150%; mso-fareast-font-family: "Times New Roman"; mso-fareast-language: IN;">6 bulan<o:p></o:p></span></div>
<div align="center" class="MsoNormal" style="line-height: 150%; margin-bottom: .0001pt; margin-bottom: 0cm; mso-margin-top-alt: auto; text-align: center;">
<span lang="EN-US" style="font-family: 'Times New Roman', serif; font-size: 12pt; line-height: 150%;">(<i>Accelerated</i>)</span><span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 150%; mso-fareast-font-family: "Times New Roman"; mso-fareast-language: IN;"><o:p></o:p></span></div>
</td>
<td style="border: inset black 1.0pt; mso-border-alt: inset black .75pt; padding: 3.0pt 3.0pt 3.0pt 3.0pt; width: 184.5pt;" valign="top" width="246"><div align="center" class="MsoNormal" style="line-height: 150%; margin-bottom: .0001pt; margin-bottom: 0cm; mso-margin-top-alt: auto; text-align: center;">
<span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 150%; mso-fareast-font-family: "Times New Roman"; mso-fareast-language: IN;">Bulan ke-3
dan 6</span><br />
<br /></div>
</td></tr>
</tbody></table>
</div>
<div class="MsoNormal" style="margin-bottom: 0cm; text-align: justify;">
<div style="line-height: 150%;">
<br /></div>
<span style="font-family: Times, Times New Roman, serif;"><span style="line-height: 150%;">Literatur mengenai studi stabilita dapat di lihat di </span><span style="line-height: 24px;">ASEAN GUIDELINE </span><span style="line-height: 24px;">ON STABILITY STUDY OF DRUG PRODUCT dan ICH HARMONISED TRIPARTITE GUIDELINE </span><span style="line-height: 24px;">STABILITY TESTING OF</span></span><br />
<span style="font-family: Times, Times New Roman, serif;"><span style="line-height: 24px;">NEW DRUG SUBSTANCES AND PRODUCTS </span><span style="line-height: 24px;">Q1A(R2).</span></span><br />
<span style="line-height: 24px;"><br /></span>
<span style="line-height: 24px;"><br /></span></div>
Andi Usman Pharmahttp://www.blogger.com/profile/00236524553139613509noreply@blogger.com5tag:blogger.com,1999:blog-4997010120417470107.post-84924776369630328662012-07-21T17:53:00.002-07:002013-01-30T07:31:51.934-08:00PROMO!!! Dapatkan buku-buku kesehatan murah hanya disini.. <a href="http://pharmapustaka.blogspot.com/">pharmapustaka.blogspot.com</a>Andi Usman Pharmahttp://www.blogger.com/profile/00236524553139613509noreply@blogger.com0tag:blogger.com,1999:blog-4997010120417470107.post-30142899590887795612011-08-13T20:17:00.000-07:002013-01-30T07:37:35.092-08:00Tugas dan tanggungjawab Quality Assurance (QA) / Jaminan Mutu<div class="MsoNormal" style="line-height: 150%; text-align: justify; text-indent: 36.0pt;">
<span style="font-family: 'Times New Roman', serif;">Departemen QA merupakan departemen yang bertanggung jawab antara lain :<o:p></o:p></span></div>
<div class="MsoNormal" style="line-height: 150%; margin-left: 21.3pt; mso-list: l0 level1 lfo1; tab-stops: list 21.3pt; text-align: justify; text-indent: -21.3pt;">
<span style="font-family: 'Times New Roman', serif;">a)<span style="font: normal normal normal 7pt/normal 'Times New Roman';"> </span></span><span style="font-family: 'Times New Roman', serif;">Audit internal <o:p></o:p></span></div>
<div class="MsoNormal" style="line-height: 150%; margin-left: 21.3pt; tab-stops: list 1.0cm; text-align: justify; text-indent: -21.3pt;">
<span style="font-family: 'Times New Roman', serif;"> QA melakukan evaluasi kerja kesemua bagian/departemen yang ada. Saat ini audit internal masih terbatas pada departemen yang berada dibawah plant manager. <o:p></o:p></span></div>
<div class="MsoNormal" style="line-height: 150%; margin-left: 21.3pt; mso-list: l0 level1 lfo1; tab-stops: list 21.3pt; text-align: justify; text-indent: -21.3pt;">
<span style="font-family: 'Times New Roman', serif;">b)<span style="font: normal normal normal 7pt/normal 'Times New Roman';"> </span></span><span style="font-family: 'Times New Roman', serif;">Audit eksternal<o:p></o:p></span></div>
<div class="MsoNormal" style="line-height: 150%; margin-left: 21.3pt; tab-stops: list 1.0cm; text-align: justify; text-indent: -21.3pt;">
<span style="font-family: 'Times New Roman', serif;"> Dilakukan terhadap supplier / pemasok baik bahan baku obat maupun bahan kemas. Saat ini departemen QA belum melakukan vendor audit karena terbatasnya SDM yang ada. Untuk memilih supplier yang dapat dipakai maka QA membuat Protap Kriteria Pemasok.</span><span lang="EN-US" style="font-family: 'Times New Roman', serif;"><o:p></o:p></span></div>
<div class="MsoNormal" style="line-height: 150%; margin-left: 21.3pt; mso-list: l0 level1 lfo1; tab-stops: list 21.3pt; text-align: justify; text-indent: -21.3pt;">
<span style="font-family: 'Times New Roman', serif;">c)<span style="font: normal normal normal 7pt/normal 'Times New Roman';"> </span></span><span style="font-family: 'Times New Roman', serif;">Inspeksi diri<o:p></o:p></span></div>
<div class="MsoNormal" style="line-height: 150%; margin-left: 21.3pt; tab-stops: list 1.0cm left 63.0pt; text-align: justify; text-indent: -21.3pt;">
<span style="font-family: 'Times New Roman', serif;"> Merupakan penilaian secara jujur terhadap kinerja perusahaan khususnya departemen yang berada dibawah plant manager. Dari hasil penilaian yang diperoleh maka dilakukan evaluasi dan disusun langkah-langkah untuk perbaikan. Inspeksi diri secara umum dilakukan setiap 6 bulan sekali dan juga diwaktu-waktu tertentu sesuai kebijakan perusahaan. <o:p></o:p></span></div>
<div class="MsoNormal" style="line-height: 150%; margin-left: 21.3pt; mso-list: l0 level1 lfo1; tab-stops: list 21.3pt; text-align: justify; text-indent: -21.3pt;">
<span style="font-family: 'Times New Roman', serif;">d)<span style="font: normal normal normal 7pt/normal 'Times New Roman';"> </span></span><span style="font-family: 'Times New Roman', serif;">Pelatihan karyawan dan staf<o:p></o:p></span></div>
<div class="MsoNormal" style="line-height: 150%; margin-left: 21.3pt; tab-stops: list 1.0cm; text-align: justify; text-indent: -21.3pt;">
<span style="font-family: 'Times New Roman', serif;"> Dalam hal ini QA bekerja sama dengan manajer yang bersangkutan. Sebelum pelatihan, QA melakukan evaluasi terhadap materi yang akan diberikan. Untuk mengukur tingkat keberhasilan pelatihan dilakukan pos test dan pengawasan kerja. <o:p></o:p></span></div>
<div class="MsoNormal" style="line-height: 150%; margin-left: 21.3pt; mso-list: l0 level1 lfo1; tab-stops: list 21.3pt; text-align: justify; text-indent: -21.3pt;">
<span style="font-family: 'Times New Roman', serif;">e)<span style="font: normal normal normal 7pt/normal 'Times New Roman';"> </span></span><span style="font-family: 'Times New Roman', serif;">Pemantauan terhadap penyimpangan<o:p></o:p></span></div>
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<span style="font-family: 'Times New Roman', serif;"> Apabila terjadi penyimpangan pada proses produksi maka QA turut serta dalam mengatasi permasalahan yang ada.<o:p></o:p></span></div>
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<span style="font-family: 'Times New Roman', serif;">f)<span style="font: normal normal normal 7pt/normal 'Times New Roman';"> </span></span><span style="font-family: 'Times New Roman', serif;">Pelatihan tim penanganan penyimpangan<o:p></o:p></span></div>
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<span style="font-family: 'Times New Roman', serif;"> Pelatihan kepada tim penanganan penyimpangan dilakukan bersana-sama dengan manajer yang bersangkutan.</span><span lang="EN-US" style="font-family: 'Times New Roman', serif;"><o:p></o:p></span></div>
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<span style="font-family: 'Times New Roman', serif;">g)<span style="font: normal normal normal 7pt/normal 'Times New Roman';"> </span></span><span style="font-family: 'Times New Roman', serif;">Tren analisis terhadap produk bermasalah<o:p></o:p></span></div>
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<span style="font-family: 'Times New Roman', serif;"> Setiap tahun dilakukan analisis terhadap produk-produk yang sering bermasalah kemudian dilakukan evaluasi. Hasil evaluasi dapat digunakan untuk dilakukan penanganan sesuai dengan permasalahan yang dihadapi.</span><span lang="EN-US" style="font-family: 'Times New Roman', serif;"><o:p></o:p></span></div>
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<span style="font-family: 'Times New Roman', serif;">h)<span style="font: normal normal normal 7pt/normal 'Times New Roman';"> </span></span><span style="font-family: 'Times New Roman', serif;">Pembuatan prosedur tetap<o:p></o:p></span></div>
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<span style="font-family: 'Times New Roman', serif;"> Bersama departemen terkait QA membuat prosedur tetap sebagai petunjuk operasional. Protap bersifat singkat, jelas dan mudah dimengerti oleh operator dari berbagai latar belakang pendidikan, tidak perlu menggunakan pendekatan ilmiah yang terlalu rumit, serta gaya penulisan dan tata bahasa yang digunakan mudah dimengerti oleh operator. Hal-hal yang perlu diperhatikan dalam pembuatan protap diantaranya sistem penomoran dokumen, kode-kode dokumen berdasarkan pengelompokan dokumen serta pendistribusian dan penyimpanan protap.</span><span lang="EN-US" style="font-family: 'Times New Roman', serif;"><o:p></o:p></span></div>
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<span style="font-family: 'Times New Roman', serif;">i)<span style="font: normal normal normal 7pt/normal 'Times New Roman';"> </span></span><span style="font-family: 'Times New Roman', serif;">Validasi<o:p></o:p></span></div>
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<span lang="EN-US" style="font-family: 'Times New Roman', serif;">QA Manager </span><span style="font-family: 'Times New Roman', serif;">menjadi ketua komite validasi </span><span lang="EN-US" style="font-family: 'Times New Roman', serif;">dengan anggota berasal dari bagian Produksi, QC/IPC, Teknik, R&D, dan bagian lain yang terkait, sesuai dengan jenis pelaksanaan validasi/kualifikasi yang dilakukan.Komite validasi merupakan sebuah <em>team </em>(kelompok) yang bertanggung jawab terhadap pelaksanaan program validasi/ kualifikasi dalam industri farmasi yang bersangkutan. <o:p></o:p></span></div>
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<span lang="EN-US" style="font-family: 'Times New Roman', serif;">Komite validasi bertanggung jawab untuk melaksanakan seluruh program validasi sesuai dengan jadwal seperti yang telah tertera pada </span><span style="font-family: 'Times New Roman', serif;">r</span><span lang="EN-US" style="font-family: 'Times New Roman', serif;">encana </span><span style="font-family: 'Times New Roman', serif;">i</span><span lang="EN-US" style="font-family: 'Times New Roman', serif;">nduk </span><span style="font-family: 'Times New Roman', serif;">v</span><span lang="EN-US" style="font-family: 'Times New Roman', serif;">alidasi (RIV). Komite </span><span style="font-family: 'Times New Roman', serif;">v</span><span lang="EN-US" style="font-family: 'Times New Roman', serif;">alidasi ini selanjutnya terbagi menjadi beberapa kelompok kerja (<em>task force</em>) sesuai dengan ruang lingkup dan pelaksananaan validasi. Misalnya dalam pelaksanaan kualifikasi mesin/peralatan penunjang, maka kelompok kerja terdiri dari </span><span style="font-family: 'Times New Roman', serif;">d</span><span lang="EN-US" style="font-family: 'Times New Roman', serif;">epartemen QA dan </span><span style="font-family: 'Times New Roman', serif;">d</span><span lang="EN-US" style="font-family: 'Times New Roman', serif;">epartemen </span><span style="font-family: 'Times New Roman', serif;">t</span><span lang="EN-US" style="font-family: 'Times New Roman', serif;">eknik (kadang-kadang juga </span><span style="font-family: 'Times New Roman', serif;">d</span><span lang="EN-US" style="font-family: 'Times New Roman', serif;">epartemen </span><span style="font-family: 'Times New Roman', serif;">p</span><span lang="EN-US" style="font-family: 'Times New Roman', serif;">roduksi dan R&D), sedangkan untuk validasi metode analisa, maka kelompok kerja terdiri dari </span><span style="font-family: 'Times New Roman', serif;">d</span><span lang="EN-US" style="font-family: 'Times New Roman', serif;">epartemen QA, </span><span style="font-family: 'Times New Roman', serif;">d</span><span lang="EN-US" style="font-family: 'Times New Roman', serif;">epartemen QC (kadang-kadang juga </span><span style="font-family: 'Times New Roman', serif;">d</span><span lang="EN-US" style="font-family: 'Times New Roman', serif;">epertemen R&D). Namun demikian secara umum, </span><span style="font-family: 'Times New Roman', serif;">d</span><span lang="EN-US" style="font-family: 'Times New Roman', serif;">epartemen QA merupakan penanggung jawab dari keseluruhan pelaksanaan program validasi pada industri farmasi tersebut.<o:p></o:p></span></div>
Andi Usman Pharmahttp://www.blogger.com/profile/00236524553139613509noreply@blogger.com3tag:blogger.com,1999:blog-4997010120417470107.post-36397509585348918062011-08-13T06:48:00.000-07:002011-08-13T06:48:31.378-07:00Purchasing (Pembelian) Industri Farmasi<br />
<div class="MsoBodyTextIndent" style="line-height: 150%; margin-left: 18.0pt; tab-stops: 18.0pt 22.5pt 27.0pt; text-align: justify; text-indent: 31.65pt;"><span lang="ES" style="font-family: "Times New Roman","serif"; mso-ansi-language: ES;">Bagian pembelian (<i>purchasing</i>) bertanggung jawab dalam melakukan pembelian<span style="mso-spacerun: yes;"> </span>keperluan perusahaan baik keperluan administrasi seperti alat tulis kantor dan alat elektronik maupun keperluan produksi obat seperti bahan baku obat, bahan kemas, dan <i>spare part</i> mesin.<o:p></o:p></span></div><div class="MsoBodyTextIndent" style="line-height: 150%; margin-bottom: .0001pt; margin-bottom: 0cm; margin-left: 18.0pt; margin-right: 0cm; margin-top: 0cm; tab-stops: 18.0pt 22.5pt 27.0pt; text-align: justify; text-indent: 31.65pt;"><span lang="ES" style="font-family: "Times New Roman","serif"; mso-ansi-language: ES;">Dalam pengadaan<span style="mso-spacerun: yes;"> </span>dan pembelian barang untuk keperluan produksi obat bagian purchasing perlu memperhatikan beberapa hal, yaitu :<o:p></o:p></span></div><div class="MsoBodyTextIndent" style="line-height: 150%; margin-bottom: .0001pt; margin-bottom: 0cm; margin-left: 18.0pt; margin-right: 0cm; margin-top: 0cm; mso-list: l1 level1 lfo1; tab-stops: 18.0pt 22.5pt 27.0pt; text-align: justify; text-indent: -18.0pt;"><!--[if !supportLists]--><span lang="X-NONE" style="font-family: "Times New Roman","serif";"><span style="mso-list: Ignore;">a.<span style="font: 7.0pt "Times New Roman";"> </span></span></span><!--[endif]--><span lang="X-NONE" style="font-family: "Times New Roman","serif";">Pemilihan <i>supplier</i><o:p></o:p></span></div><div class="MsoBodyTextIndent" style="line-height: 150%; margin-bottom: .0001pt; margin-bottom: 0cm; margin-left: 18.0pt; margin-right: 0cm; margin-top: 0cm; mso-list: l1 level1 lfo1; tab-stops: 18.0pt 22.5pt 27.0pt; text-align: justify; text-indent: -18.0pt;"><!--[if !supportLists]--><span lang="SV" style="font-family: "Times New Roman","serif"; mso-ansi-language: SV;"><span style="mso-list: Ignore;">b.<span style="font: 7.0pt "Times New Roman";"> </span></span></span><!--[endif]--><span lang="SV" style="font-family: "Times New Roman","serif"; mso-ansi-language: SV;">Stok bahan yang ada baik bahan baku, bahan kemas, dan produk jadi<o:p></o:p></span></div><div class="MsoBodyTextIndent" style="line-height: 150%; margin-bottom: .0001pt; margin-bottom: 0cm; margin-left: 18.0pt; margin-right: 0cm; margin-top: 0cm; mso-list: l1 level1 lfo1; tab-stops: 18.0pt 22.5pt 27.0pt; text-align: justify; text-indent: -18.0pt;"><!--[if !supportLists]--><i><span lang="X-NONE" style="font-family: "Times New Roman","serif";"><span style="mso-list: Ignore;">c.<span style="font: 7.0pt "Times New Roman";"> </span></span></span></i><!--[endif]--><i><span lang="X-NONE" style="font-family: "Times New Roman","serif";">Lead time<o:p></o:p></span></i></div><div class="MsoBodyTextIndent" style="line-height: 150%; margin-left: 18.0pt; text-align: justify; text-indent: 18.0pt;"><span lang="SV" style="font-family: "Times New Roman","serif"; mso-ansi-language: SV;">Hal-hal yang menjadi pertimbangan </span><span lang="PT-BR" style="font-family: "Times New Roman","serif"; mso-ansi-language: PT-BR;">dalam memilih supplier adalah :<o:p></o:p></span></div><div class="MsoBodyTextIndent" style="line-height: 150%; margin-bottom: .0001pt; margin-bottom: 0cm; margin-left: 18.0pt; margin-right: 0cm; margin-top: 0cm; mso-list: l0 level1 lfo2; text-align: justify; text-indent: -18.0pt;"><!--[if !supportLists]--><span lang="X-NONE" style="font-family: "Times New Roman","serif";"><span style="mso-list: Ignore;">1)<span style="font: 7.0pt "Times New Roman";"> </span></span></span><!--[endif]--><span lang="PT-BR" style="font-family: "Times New Roman","serif"; mso-ansi-language: PT-BR;">Kualitas dari bahan yang dipesan. Hal ini dapat diketahui berdasarkan <i>Certificate of Analysis</i> (COA) yang disertakan pada pembelian dan sampel yang dikirim pada PT. </span><span lang="X-NONE" style="font-family: "Times New Roman","serif";">Berlico Mulia Farma.<o:p></o:p></span></div><div class="MsoBodyTextIndent" style="line-height: 150%; margin-bottom: .0001pt; margin-bottom: 0cm; margin-left: 18.0pt; margin-right: 0cm; margin-top: 0cm; mso-list: l0 level1 lfo2; text-align: justify; text-indent: -18.0pt;"><!--[if !supportLists]--><span lang="PT-BR" style="font-family: "Times New Roman","serif"; mso-ansi-language: PT-BR;"><span style="mso-list: Ignore;">2)<span style="font: 7.0pt "Times New Roman";"> </span></span></span><!--[endif]--><span lang="PT-BR" style="font-family: "Times New Roman","serif"; mso-ansi-language: PT-BR;">Kontinuitas atau kesanggupan supplier dalam menyuplai barang.<o:p></o:p></span></div><div class="MsoBodyTextIndent" style="line-height: 150%; margin-bottom: .0001pt; margin-bottom: 0cm; margin-left: 18.0pt; margin-right: 0cm; margin-top: 0cm; mso-list: l0 level1 lfo2; text-align: justify; text-indent: -18.0pt;"><!--[if !supportLists]--><span lang="PT-BR" style="font-family: "Times New Roman","serif"; mso-ansi-language: PT-BR;"><span style="mso-list: Ignore;">3)<span style="font: 7.0pt "Times New Roman";"> </span></span></span><!--[endif]--><i><span lang="PT-BR" style="font-family: "Times New Roman","serif"; mso-ansi-language: PT-BR;">Delivery time</span></i><span lang="PT-BR" style="font-family: "Times New Roman","serif"; mso-ansi-language: PT-BR;"> (yaitu waktu dari <i>supplier </i>mengirim barang sampai ke tempat tujuan).<o:p></o:p></span></div><div class="MsoBodyTextIndent" style="line-height: 150%; margin-bottom: .0001pt; margin-bottom: 0cm; margin-left: 18.0pt; margin-right: 0cm; margin-top: 0cm; mso-list: l0 level1 lfo2; text-align: justify; text-indent: -18.0pt;"><!--[if !supportLists]--><span lang="SV" style="font-family: "Times New Roman","serif"; mso-ansi-language: SV;"><span style="mso-list: Ignore;">4)<span style="font: 7.0pt "Times New Roman";"> </span></span></span><!--[endif]--><span lang="SV" style="font-family: "Times New Roman","serif"; mso-ansi-language: SV;">Layanan purna jual, seperti adanya tanggapan atas keluhan yang diajukan.<o:p></o:p></span></div><div class="MsoBodyTextIndent" style="line-height: 150%; margin-bottom: .0001pt; margin-bottom: 0cm; margin-left: 18.0pt; margin-right: 0cm; margin-top: 0cm; mso-list: l0 level1 lfo2; text-align: justify; text-indent: -18.0pt;"><!--[if !supportLists]--><span lang="X-NONE" style="font-family: "Times New Roman","serif";"><span style="mso-list: Ignore;">5)<span style="font: 7.0pt "Times New Roman";"> </span></span></span><!--[endif]--><span lang="X-NONE" style="font-family: "Times New Roman","serif";">Kemudahan dalam melakukan pembayaran.<o:p></o:p></span></div><div class="MsoBodyTextIndent" style="line-height: 150%; margin-left: 18.0pt; mso-list: l0 level1 lfo2; text-align: justify; text-indent: -18.0pt;"><!--[if !supportLists]--><span lang="X-NONE" style="font-family: "Times New Roman","serif";"><span style="mso-list: Ignore;">6)<span style="font: 7.0pt "Times New Roman";"> </span></span></span><!--[endif]--><span lang="X-NONE" style="font-family: "Times New Roman","serif";">Untuk mengantisipasi hal-hal yang tidak diinginkan dalam hal pengadaan persediaan maka dipilih minimal dua <i>supplier </i>yang berbeda untuk setiap bahan.<o:p></o:p></span></div>Andi Usman Pharmahttp://www.blogger.com/profile/00236524553139613509noreply@blogger.com1