PIC/S ANEKS 2 (PEMBUATAN BAHAN DAN PRODUK BIOLOGI UNTUK PENGGUNAAN MANUSIA) – BAGIAN A. PEDOMAN UMUM: PERSONALIA

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 and tested should receive training, and periodic retraining, specific to the products manufactured and to their work, including any specific measures to protect product, personnel and the environment.

Personel (termasuk yang berhubungan dengan pembersihan, pemeliharaan atau pengawasan mutu) yang digunakan di area di mana produk biologi dibuat dan diuji haruslah menerima pelatihan, dan pelatihan ulang berkala, spesifik untuk produk yang dibuat dan untuk pekerjaan mereka, termasuk tindakan khusus untuk melindungi produk, personel dan lingkungan.

2 The health status of personnel should be taken into consideration for product safety. Where necessary, personnel engaged in production, maintenance, testing and animal care (and inspections) should be vaccinated with appropriate specific vaccines and have regular health checks.

Status kesehatan personel harus dipertimbangkan untuk keamanan produk. Jika diperlukan, personel yang terlibat dalam produksi, pemeliharaan, pengujian dan perawatan hewan (dan inspeksi) harus divaksinasi dengan vaksin spesifik yang sesuai dan melakukan pemeriksaan kesehatan secara reguler.

3 Any changes in the health status of personnel, which could adversely affect the quality of the product, should preclude work in the production area and appropriate records kept. Production of BCG vaccine and tuberculin products should be restricted to staff who are carefully monitored by regular checks of immunological status or chest X-ray. Health monitoring of staff should be commensurate with the risk, medical advice should be sought for personnel involved with hazardous organisms.

Setiap perubahan dalam status kesehatan personel, yang dapat…