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

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 the quality of the final product.

Manajemen perubahan harus, secara periodik, memperhitungkan efeknya, termasuk efek kumulatif perubahan (misalnya proses) pada mutu produk akhir.

49 Critical operational (process) parameters, or other input parameters which affect product quality, need to be identified, validated, documented and be shown to be maintained within requirements.

Parameter (proses) operasional kritis, atau parameter input lain yang mempengaruhi mutu produk, perlu diidentifikasi, divalidasi, didokumentasikan dan dipertahankan dalam persyaratan.

50 A control strategy for the entry of articles and materials into production areas should be based on QRM principles to minimise the risk of contamination. For aseptic processes, heat stable articles and materials entering a clean area or clean/contained area should preferably do so through a double-ended autoclave or oven. Heat labile articles and materials should enter through an air lock with interlocked doors where they are subject to effective surface sanitisation procedures. Sterilisation of articles and materials elsewhere is acceptable provided that they are multiple wrappings, as appropriate to the number of stages of entry to the clean area, and enter through an airlock with the appropriate surface sanitisation precautions.

Strategi pengendalian masuknya barang dan bahan ke dalam area produksi harus didasarkan pada prinsip MRM guna meminimalkan risiko kontaminasi. Untuk proses aseptik, masuknya barang dan bahan yang tahan panaske area bersih atau area bersih/terkungkung sebaiknya dilakukan melalui otoklaf atau oven pintu ganda. Barang dan bahan yang…