Badan Pengawas Obat dan Makanan Republik Indonesia ...

Aneks 12 – Cara Penyimpanan danPengiriman Obat yang Baikdan pengirimannya hendaklahdilaksanakan sesuai prinsip CPOB danCDOB.Annex 12 – Good Storage andDispatch Practicesin the storage and dispatch thereofshould be carried out according to theprinciples of GMP, and GDP.PERSONALIA4. Semua personalia yang terlibat dalamkegiatan penyimpanan dan pengirimanhendaklah dilatih dalam semuapersyaratan dalam Aneks ini danhendaklah mampu memenuhipersyaratan tersebut.5. Personalia kunci yang terlibat dalampenyimpanan dan pengiriman produkhendaklah memiliki kemampuan danpengalaman yang sesuai dengantanggung jawab mereka untukmemastikan bahwa produk disimpandan dikirimkan dengan tepat.6. Prosedur dan kondisi kerja bagikaryawan, termasuk karyawan kontrakdan karyawan temporer, sertapersonalia lain yang mempunyai aksespada produk harus dirancang dan dijagauntuk membantu meminimalkankemungkinan produk jatuh ke pihakyang tidak berwenang.7. Kode praktik dan prosedur disiplinhendaklah diterapkan untuk mencegahdan menangani situasi di manapersonalia yang terlibat dalampenyimpanan dan pengiriman produkdiduga atau terbukti terlibat didalampenyalahgunaan dan/atau pencurian.PERSONNEL4. All personnel involved in storage anddispatch activities should be trained inall requirements of this Annex and becapable of meeting these requirements.5. Key personnel involved in the storageand dispatch of pharmaceutical productsshould have the ability and experienceappropriate to their responsibility forensuring that pharmaceutical productsare stored and dispatched properly.6. Procedures and conditions ofemployment for employees, includingcontract and temporary staff, and otherpersonnel having access topharmaceutical products must bedesigned and administered to assist inminimizing the possibility of suchproducts coming into unauthorizedpossession.7. Codes of practice and disciplinaryprocedures should be in place toprevent and address situations wherepersons involved in the storage anddispatch of pharmaceutical products aresuspected of, or found to be implicatedin, the misappropriation and/or theftthereof.ORGANISASI DAN MANAJEMEN8. Bagian gudang hendaklah termasukdalam struktur organisasi industrifarmasi. Tanggung jawab, kewenangandan hubungan timbal-balik semuapersonalia hendaklah ditunjukkandengan jelas.9. Tiap personalia hendaklah tidakdibebani tanggung jawab yangberlebihan untuk menghindari risikoORGANIZATION AND MANAGEMENT8. The warehouse should be included inthe organizational structure of thepharmaceutical industry. Theresponsibility, authority andinterrelationships of all personnel shouldbe clearly indicated.9. The responsibilities placed on any oneindividual should not be so extensive asto present any risk to product quality.Edisi 2009 - 109 - 2009 Edition