Badan Pengawas Obat dan Makanan Republik Indonesia ...

Daftar IsiSterilisasi .................................... 36Filtrasi Produk yang Tidak DapatDisterilkan dalam WadahAkhirnya ..................................... 43Indikator Biologis dan Kimiawi .... 44Penyelesaian Produk Steril ........ 45Pengawasan Mutu ..................... 47ANEKS 9 – PEMBUATANRADIOFARMAKA ..... 49Ruang Lingkup ........................... 49Prinsip ......................................... 50Otorita Pengawasan .................... 50Personalia .................................. 51Bangunan dan Peralatan ............ 54Produksi ..................................... 60Produksi Steril ............................ 65Pelabelan ................................... 67Catatan Produksi danDistribusi ..................................... 71Pengawasan Mutu ..................... 71Dokumentasi .............................. 77Distribusi dan PenarikanKembali Produk .......................... 79Proteksi dan Keselamatanterhadap Radiasi ........................ 79Persyaratan Minimum untukPelulusan Produk ....................... 79Persyaratan Minimum untukFasilitas Pelulusan ...................... 80Glosarium ................................... 85Lampiran Glosarium ................ 88ANEKS 10 – PENGGUNAANRADIASI PENGIONDALAM PEMBUATANOBAT ......................... 91Pendahuluan ............................... 91Tanggung Jawab ......................... 91Dosimetri ..................................... 92Validasi Proses ........................... 93Commissioning Fasilitas ............. 94Bangunan .................................... 97Pemrosesan ................................ 98Dokumentasi .............................. 99Pemantauan Mikrobiologi ........... 100Table of ContentSterilization .................................. 36Filtration of PharmaceuticalProducts Which Cannot beSterilized in Their Final Container . 43Biological and Chemical Indicators 44Finishing of Sterile Products ........ 45Quality Control ............................. 47ANNEX 9 – MANUFACTURE OFRADIO-PHARMACEUTICALS… 49Scope ............................................ 49Principle ........................................ 50Regulatory Control ........................ 50Personnel ...................................... 51Premises and Equipment .............. 54Produksi ....................................... 60Sterile Production ......................... 65Labeling ....................................... 67Production and DistributionRecords ........................................ 71Quality Control ............................. 71Documentation ............................. 77Distribution and Recalls ............... 79Radiation Protection and Safety ... 79Minimum Requirement for ProductRelease ........................................ 79Facility for Release-MinimumRequirement ................................ 80Glossary ....................................... 85Attachment to Glossary ........... 88ANNEX 10 – THE USE OF IONIZINGRADIATION IN THEMANUFACTURE OFMEDICINALPRODUCTS ................. 91Introduction .................................. 91Responsibility ............................... 91Dosimetry ..................................... 92Validation of Process ................... 93Commissioning of the Plant ......... 94Premises ....................................... 97Processing ................................... 98Documentation ............................. 99Microbiological Monitoring ............ 100Edisi 2009 - v - 2009 Edition