PIC/S ANEKS 2 (PEMBUATAN BAHAN DAN PRODUK BIOLOGI UNTUK PENGGUNAAN MANUSIA) – DOKUMENTASI

PIC/S ANEKS 2 (PEMBUATAN BAHAN DAN PRODUK BIOLOGI UNTUK PENGGUNAAN MANUSIA) – DOKUMENTASI

NO VERSI ASLI VERSI TERJEMAHAN 26 Specifications for biological starting materials may need additional documentation on the source, origin, distribution chain, method of manufacture, and controls applied, to assure an appropriate level of control including their microbiological quality.

Spesifikasi untuk bahan awal biologi mungkin memerlukan dokumentasi tambahan tentang sumber, asal, rantai distribusi, metode pembuatan, dan pengendalian yang diterapkan, untuk memastikan tingkat pengendalian yang tepat termasuk mutu mikrobiologinya.

27 Some product types may require specific definition of what materials constitutes a batch, particularly somatic cells in the context of ATMPs. For autologous and donor-matched situations, the manufactured product should be viewed as a batch.

Beberapa jenis produk mungkin memerlukan definisi spesifik tentang bahan apa yang membentuk bets, terutama sel somatik dalam PTTT. Untuk situasi autologus dan kecocokan-donor, produk yang diproduksi harus dilihat sebagai bets.

28 Where human cell or tissue donors are used, full traceability is required from starting and raw materials, including all substances coming into contact with the cells or tissues through to confirmation of the receipt of the products at the point of use whilst maintaining the privacy of individuals and confidentiality of health related information17. Traceability records18 must be retained for 30 years after the expiry date of the product. Particular care should be taken to maintain the traceability of products for special use cases, such as donor-matched cells. National requirements apply to blood components when they are used as supportive or raw material in the manufacturing process of medicinal products19.

For ATMPs, traceability requirement regarding human cells including haematopoietic cells must comply with the principles laid…