Руководящие документы по надлежащей производственной практике Всемирной организации здравохранения
Руковадство по надлежащей производственной практике (GMP). Часть 1: СОП.
Руководство ВОЗ по требованиям GMP надлежащей практике организации производства. Часть 2. Валидация.
Introduction
2. Good manufacturing practices: starting materials Active pharmaceutical ingredients (bulk drug substances) Pharmaceutical excipients 3. Good manufacturing practices: specific pharmaceutical products Biological products Investigational pharmaceutical products for clinical trials in humans Herbal medicinal products 4. Inspection Inspection of pharmaceutical manufacturers Inspection of drug distribution channels
2. Good manufacturing practices: starting materials
Active pharmaceutical ingredients (bulk drug substances) Pharmaceutical excipients
3. Good manufacturing practices: specific pharmaceutical products
Biological products Investigational pharmaceutical products for clinical trials in humans Herbal medicinal products
4. Inspection
Inspection of pharmaceutical manufacturers Inspection of drug distribution channels