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

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

NO VERSI ASLI VERSI TERJEMAHAN 5 As part of the control strategy, the degree of environmental control of particulate and microbial contamination of the production premises should be adapted to the product and the production step, bearing in mind the level of contamination of the starting materials and the risks to the product. The environmental monitoring programme in addition to Annex 1 should be supplemented by the inclusion of methods to detect the presence of specific microorganisms (e.g. host organism, anaerobes, etc) where indicated by the QRM process.

Sebagai bagian dari strategi pengendalian, tingkat pengendalian lingkungan dari kontaminasi partikulat dan mikroba di sarana produksi harus disesuaikan dengan produk dan tahap produksi, dengan mempertimbangkan tingkat kontaminasi bahan awal dan risiko terhadap produk. Program pemantauan lingkungan selain yang tertera pada Aneks 1 harus dilengkapi dengan metode untuk mendeteksi keberadaan mikroorganisme tertentu (misalnya organisme inang, anaerob, dll) yang diindikasikan oleh proses MRM.

6 Manufacturing and storage facilities, processes and environmental classifications should be designed to prevent the extraneous contamination of products. Although contamination is likely to become evident during processes such as fermentation and cell culture, prevention of contamination is more appropriate than detection and removal. In fact, the environmental monitoring and material bioburden testing programs are intended to verify a state of control. Where processes are not closed and there is therefore exposure of the product to the immediate room environment (e.g. during additions of supplements, media, buffers, gasses, manipulations during the manufacture of ATMPs) measures should be put in place, including engineering and environmental controls on the basis of QRM principles. These QRM principles should take into account…