Badan Pengawas Obat dan Makanan Republik Indonesia ...

Aneks 1 – Pembuatan Produk Sterildensitas kemasan dipertimbangkan.122. Prosedur penanganan bahan hendaklahdapat mencegah campur-baur bahanyang sudah diradiasi dan yang belum.Cakram warna peka-radiasi hendaklahdipakai pada tiap kemasan untukmembedakan kemasan yang telahdiradiasi dan yang belum.123. Dosis total radiasi hendaklah diberikandalam kurun waktu yang telahditentukan.124. Jumlah wadah yang masuk, diradiasidan dikeluarkan hendaklah direkonsiliasisatu dengan yang lain dan dengandokumen yang berkaitan. Tiappenyimpangan hendaklah dilaporkandan diselidiki dengan tuntas.125. Operator pelaksana radiasi hendaklahmenyertifikasi rentang dosis yangditerima oleh wadah yang teradiasidalam satu bets atau pengiriman.126. Catatan proses dan pengawasan untuktiap bets radiasi hendaklah diperiksadan ditandatangani oleh personalia yangbertanggung jawab dan catatan tersebuthendaklah disimpan. Metode dantempat penyimpanan hendaklahdisetujui oleh operator pelaksana radiasidan industri pemilik izin edar.127. Pemantauan mikrobiologis adalahtanggung jawab industri, yangmencakup pemantauan lingkungan saatproduk dibuat dan pemantauanpraradiasi sesuai yang tercantum padadokumen izin edar.(Lihat juga Aneks 10 Penggunaan RadiasiPengion dalam Pembuatan Obat)Sterilisasi dengan Gas dan Fumigan128. Metode sterilisasi ini hendaklah hanyadigunakan bila cara lain tidak dapatditerapkan. Selama proses validasihendaklah dibuktikan bahwa tidak adaAnnex 1 – Manufacture of SterilePharmaceutical Productspackages are considered.122. Materials handling procedures shouldprevent mix-up between irradiated andnon-irradiated materials. Radiationsensitivecolour disks should also beused on each package to differentiatebetween packages which have beensubjected to an irradiation and thosewhich have not.123. The total radiation dose should beadministered within a predeterminedtime span.124. The numbers of containers received,irradiated and dispatched should bereconciled with each other and with theassociated documentation. Anydiscrepancy should be reported andresolved.125. The irradiation plant operator shouldcertify in writing the range of dosesreceived by its irradiated containerwithin a batch or delivery.126. Process and control records for eachirradiation batch should be checked andsigned by a nominated responsibleperson and retained. The method andplace of retention should be agreedbetween the plant operator and theholder of the marketing authorization.127. Microbiological monitoring is theresponsibility of the pharmaceuticalmanufacturer. It may includeenvironmental monitoring where productis manufactured and pre-irradiationmonitoring of the product as specified inthe marketing authorization.(See also Annex 10 Use of IonisingRadiation in The Manufacture of MedicinalProduct)Sterilization by Gases and Fumigants128. This method of sterilization should onlybe used when no other method ispracticable. During process validation itshould be shown that there is noEdisi 2009 - 41 - 2009 Edition