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Aneks 9 – Pembuatan RadiofarmakaAnnex 9 – Manufacture ofRadiopharmaceuticalsdirekomendasikan).CATATAN PRODUKSI DAN DISTRIBUSI98. Catatan produksi bets produk rutinharus memuat sejarah pembuatan tiapbets radiofarmaka secara lengkap, danmenunjukkan bahwa produk telahdibuat, diuji, diisi, dikemas dandidistribusikan sesuai prosedur tertulis.99. Catatan terpisah untuk penerimaan,penyimpanan, pemakaian danpemusnahan bahan radioaktifhendaklah disimpan sesuai peraturanproteksi radiasi.100. Catatan distribusi hendaklah disimpan.Karena pengembalian produk radioaktiftidak praktis, prosedur penarikankembali produk tersebut lebihditekankan pada pencegahanpenggunaan produk kembalian daripadapelaksanaan pengembalian produk itusendiri. Pengembalian produk radioaktif,bila perlu, hendaklah dilaksanakanmenurut peraturan transportasi nasionaldan atau internasional.PRODUCTION AND DISTRIBUTIONRECORDS98. The production records of regularproduction batches must provide acomplete account of the manufacturinghistory of each batch of aradiopharmaceutical, showing that it hasbeen manufactured, tested, dispensedinto containers and distributed inaccordance with the written procedures.99. Separate records for the receipt,storage, use and disposal of radioactivematerials should be maintained inaccordance with radiation protectionregulations.100. Distribution records should be kept.Since the return of radioactive productsis not practical, the purpose of recallprocedures for such products is toprevent their use rather than an actualreturn. If necessary, the return ofradioactive products should be carriedout in accordance with international andor national transport regulations.PENGAWASAN MUTU101. Beberapa radiofarmaka (misal yangberumur pendek) digunakan sebelumseluruh parameter uji kualitas (misal ujisterilitas, endotoksin, kemurnianradionuklida, dll.) selesai dikerjakan.Untuk itu, implementasi dan kepatuhanterhadap sistem Pemastian Mutu mutlakdilaksanakan.Pengambilan Sampel102. Jumlah sampel yang biasanyadiambil dalam analisis sediaanfarmasi mungkin perlu dimodifikasi,tetapi hendaklah memadai untukdilakukan pengujian ulang (sampelpembanding).QUALITY CONTROL101. Several radiopharmaceuticals (e.g.,short-lived radiopharmaceuticals) areused before all quality control testing(e.g. tests for sterility, endotoxin,radionuclidic purity, etc.) has beencompleted. The implementation of andcompliance with the Quality Assurancesystem are therefore essential.Sampling102. The number of samples normally takenin pharmaceutical analysis may have tobe modified but should be adequate topermit repeat testing (referencesamples).Edisi 2009 - 71 - 2009 Edition