PIC/S ANEKS 2 (PEMBUATAN BAHAN DAN PRODUK BIOLOGI UNTUK PENGGUNAAN MANUSIA) – B1. PRODUK BERASAL DARI HEWAN

PIC/S ANEKS 2 (PEMBUATAN BAHAN DAN PRODUK BIOLOGI UNTUK PENGGUNAAN MANUSIA) – B1. PRODUK BERASAL DARI HEWAN

NO VERSI ASLI VERSI TERJEMAHAN This guidance applies to animal materials which includes materials from establishments such as abattoirs. Since the supply chains can be extensive and complex, controls based on QRM principles need to be applied, see also requirements of appropriate pharmacopoeial monographs, including the need for specific tests at defined stages. Documentation to demonstrate the supply chain traceability30 and clear roles of participants in the supply chain, typically including a sufficiently detailed and current process map, should be in place.

Panduan ini berlaku untuk bahan-bahan hewani yang mencakup bahan-bahan dari lembaga seperti rumah potong hewan. Karena rantai pasokan bisa luas dan kompleks, pengendalian berdasarkan prinsip MRM perlu diterapkan, lihat juga persyaratan monografi farmakope yang tepat, termasuk kebutuhan untuk uji khusus pada tahap yang ditentukan. Dokumentasi untuk menunjukkan ketertelusuran rantai pasokan30 dan peran yang jelas dari para pelaku rantai pasokan, biasanya termasuk peta proses yang cukup rinci dan terkini, haruslah ada.

30 See PIC/S GMP Chapter 5.

30 Lihat PIC/S GMP Bab 5.

1 Monitoring programmes should be in place for animal disease that are of concern to human health. Organisations should take into account reports from trustworthy sources on national disease prevalence and control measures when compiling their assessment of risk and mitigation factors. Such organisations include the World Organisation for Animal Health (OIE, Office International des Epizooties31). This should be supplemented by information on health monitoring and control programme(s) at national and local levels, the latter to include the sources (e.g. farm or feedlot) from which the animals are drawn and…