PIC/S ANEKS 2 (PEMBUATAN BAHAN DAN PRODUK BIOLOGI UNTUK PENGGUNAAN MANUSIA) – SISTEM LOT BENIH DAN BANK SEL

PIC/S ANEKS 2 (PEMBUATAN BAHAN DAN PRODUK BIOLOGI UNTUK PENGGUNAAN MANUSIA) – SISTEM LOT BENIH DAN BANK SEL

NO VERSI ASLI VERSI TERJEMAHAN 39 In order to prevent the unwanted drift of properties which might ensue from repeated subcultures or multiple generations, the production of biological medicinal substances and products obtained by microbial culture, cell culture or propagation in embryos and animals should be based on a system of master and working virus seed lots and/or cell banks. Such a system may not be applicable to all types of ATMPs.

Untuk mencegah perubahan sifat yang tidak diinginkan akibat subkultur berulang atau pelipatgandaan generasi, pembuatan bahan biologi dan produk yang diperoleh dari kultur mikroba, kultur sel atau propagasi pada embrio dan hewan harus didasarkan pada sistem lot benih induk dan benih kerja virus dan/atau bank sel kerja. Sistem semacam itu mungkin tidak berlaku untuk semua jenis PTTT.

40 The number of generations (doublings, passages) between the seed lot or cell bank, the drug substance and finished product should be consistent with specifications in the MA or CTA.

Jumlah generasi (penggandaan, pasase) antara lot benih atau bank sel, bahan obat dan produk jadi harus konsisten dengan spesifikasi di izin edar atau persetujuan uji klinik.

41 As part of product lifecycle management, establishment of seed lots and cell banks, including master and working generations, should be performed under circumstances which are demonstrably appropriate. This should include an appropriately controlled environment to protect the seed lot and the cell bank and the personnel handling it. During the establishment of the seed lot and cell bank, no other living or infectious material (e.g. virus, cell lines or…