Badan Pengawas Obat dan Makanan Republik Indonesia ...

Aneks 9 – Pembuatan Radiofarmakayang bertanggung jawab untukpengawasan radiofarmaka yaitu BadanPengawas Obat dan Makanan RepublikIndonesia (BADAN POM RI) dan BadanPengawas Tenaga Nuklir (BAPETEN).Catatan: Pembuatan radiofarmaka harusmengikuti Pedoman CPOB 2006 secaraumum dan juga Aneks 1 Pembuatan ProdukSteril untuk pembuatan radiofarmaka steril.Beberapa ketentuan yang berlaku spesifikterhadap penanganan bahan radioaktif harusmengikuti peraturan yang diterbitkanBAPETEN, antara lain yang menetapkanstandar dasar bagi perlindungan kesehatanmasyarakat umum dan karyawan terhadapbahaya radiasi pengion.Annex 9 – Manufacture ofRadiopharmaceuticalsagencies with major responsibility forcontrolling of radioactive drug products,i.e. the National Agency of Drug andFood Control (NADFC) and the NuclearEnergy Regulatory Agency.Note: The manufacture ofradiopharmaceuticals must be undertaken inaccordance with Guideline on GoodManufacturing Practices for PharmaceuticalProducts, Edition 2006 and also Annex 1Manufacture of Sterile Pharmaceuticals forsterile radiopharmaceutical preparationswhere appropriate. Some points arenevertheless specific to the handling ofradioactive products must comply with therequirements of BAPETEN Directives,among others laying down the basicstandards for the health protection of thegeneral public and workers against thedangers of ionising radiation.PERSONALIA10. Semua personalia (termasuk petugaspembersihan dan perawatan ) yangbekerja di area pembuatan produkradioaktif hendaklah mendapat pelatihantambahan, khususnya mengenaiperlindungan terhadap radiasi.11. Fasilitas pembuatan radiofarmaka,apakah suatu rumah sakit, pusatradiofarmasi, pusat atau institusi nuklir,industri farmasi, atau pusat PET,termasuk para personalia yang bekerjadi dalam lembaga tersebut hendaklahberada di bawah pengawasan seorangyang memiliki catatan pembuktiankeberhasilan akademis sertamenunjukkan keahlian dan pengalamanpraktis dalam bidang radiofarmasi danhigiene radiasi. Personalia pendukungakademis dan personalia teknishendaklah memiliki pendidikan pascasarjana yang diperlukan atau pelatihanteknis dan pengalaman sesuai denganfungsinya.12. Personalia yang bekerja di arearadioaktif, area bersih dan area aseptis,hendaklah hati-hati diseleksi, untukmemastikan bahwa mereka dapatPERSONNEL10. All personnel (including those concernedwith cleaning and maintenance)employed in areas where radioactiveproducts are manufactured shouldreceive additional training. In particular,on protection against radiation.11. The manufacturing establishment,whether a hospital radiopharmacy,centralized radiopharmacy, nuclearcentre or institution, industrialmanufacturer or PET centre, and itspersonnel should be under the control ofa person who has a proven record ofacademic achievement together with ademonstrated level of practical expertiseand experience in radiopharmacy andradiation hygiene. Supporting academicand technical personnel should have thenecessary postgraduate or technicaltraining and experience appropriate totheir function.12. Personnel required to work inradioactive, clean and aseptic areasshould be selected with care, to ensurethat they can be relied on to observe theEdisi 2009 - 51 - 2009 Edition