PIC/S ANEKS 2 (PEMBUATAN BAHAN DAN PRODUK BIOLOGI UNTUK PENGGUNAAN MANUSIA) – PRINSIP KERJA NO VERSI ASLI VERSI TERJEMAHAN 48 Change management should, on a periodic basis, take into account the effects, including cumulative effects of changes (e.g. to the process) on…

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,…

PIC/S ANEKS 2 (PEMBUATAN BAHAN DAN PRODUK BIOLOGI UNTUK PENGGUNAAN MANUSIA) – BAHAN AWAL NO VERSI ASLI VERSI TERJEMAHAN 31 The source, origin and suitability of biological starting and raw materials (e.g. cryoprotectants, feeder cells, reagents, culture media, buffers, serum, enzymes, cytokines,…

PIC/S ANEKS 2 (PEMBUATAN BAHAN DAN PRODUK BIOLOGI UNTUK PENGGUNAAN MANUSIA) – PRODUKSI NO VERSI ASLI VERSI TERJEMAHAN 29 Given the variability inherent in many biological substances and products, steps to increase process robustness thereby reducing process variability and enhancing reproducibility at…

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…

PIC/S ANEKS 2 (PEMBUATAN BAHAN DAN PRODUK BIOLOGI UNTUK PENGGUNAAN MANUSIA) – HEWAN NO VERSI ASLI VERSI TERJEMAHAN 19 A wide range of animal species are used in the manufacture of a number of biological medicinal products or starting materials. These can…

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…

PIC/S ANEKS 2 (PEMBUATAN BAHAN DAN PRODUK BIOLOGI UNTUK PENGGUNAAN MANUSIA) – BAGIAN A. PEDOMAN UMUM: PERSONALIA NO VERSI ASLI VERSI TERJEMAHAN 1 Personnel (including those concerned with cleaning, maintenance or quality control) employed in areas where biological medicinal products are manufactured…

PIC/S ANEKS 2 (PEMBUATAN BAHAN DAN PRODUK BIOLOGI UNTUK PENGGUNAAN MANUSIA) – PRINSIP NO VERSI ASLI VERSI TERJEMAHAN The manufacture of biological medicinal products involves certain specific considerations arising from the nature of the products and the processes. The ways in which…

PIC/S ANEKS 2 (PEMBUATAN BAHAN DAN PRODUK BIOLOGI UNTUK PENGGUNAAN MANUSIA) – RUANG LINGKUP NO VERSI ASLI VERSI TERJEMAHAN The methods employed in the manufacture of biological medicinal substances and products are a critical factor in shaping the appropriate regulatory control. Biological…