PIC/S ANEKS 2 (PEMBUATAN BAHAN DAN PRODUK BIOLOGI UNTUK PENGGUNAAN MANUSIA) – B7. PRODUK HEWAN TRANSGENIK

PIC/S ANEKS 2 (PEMBUATAN BAHAN DAN PRODUK BIOLOGI UNTUK PENGGUNAAN MANUSIA) – B7. PRODUK HEWAN TRANSGENIK

NO VERSI ASLI VERSI TERJEMAHAN Consistency of starting material from a transgenic source is likely to be more problematic than is normally the case for non-transgenic biotechnology sources. Consequently, there is an increased requirement to demonstrate batch-to-batch consistency of product in all respects.

Konsistensi bahan awal dari sumber transgenik cenderung lebih bermasalah daripada sumber bioteknologi non-transgenik. Akibatnya, ada peningkatan persyaratan untuk menunjukkan konsistensi setiap bets dalam semua hal.

1 A range of species may be used to produce biological medicinal products, which may be expressed into body fluids (e.g. milk) for collection and purification. Animals should be clearly and uniquely identified and backup arrangements should be put in place in the event of loss of the primary marker.

Berbagai spesies dapat digunakan untuk menghasilkan produk biologi, yang dapat diekspresikan ke dalam cairan tubuh (misalnya susu) untuk pengumpulan dan pemurnian. Hewan harus diidentifikasi secara jelas dan unik dan pengaturan cadangan harus tersedia pada saat kehilangan penanda primer.

2 The arrangements for housing and care of the animals should be defined such that they minimise the exposure of the animals to pathogenic and zoonotic agents. Appropriate measures to protect the external environment should be established. A health-monitoring programme should be established and all results documented, any incident should be investigated and its impact on the continuation of the animal and on previous batches of product should be determined. Care should be taken to ensure that any therapeutic products used to treat the animals do not contaminate the product.

Pengaturan kandang dan perawatan hewan harus didefinisikan sedemikian…