WHO · TRS Annexes
WHO TRS 부속서 모음
세계보건기구(WHO) 의약품 표준 전문가위원회 기술보고서(TRS)의 부속서 가운데 GMP·품질 관련 문서를 발행일 순으로 선별해 정리했습니다. WHO 사전적격성평가(PQ)나 국제 조달 요건을 다룰 때 기준이 되는 문서들입니다. 법적 효력과 최신본은 반드시 공식 원문에서 확인하세요.
- TRS 1067 Annex 2 WHO points to consider in continuous manufacturing of pharmaceutical products
- TRS 1060 Annex 4 Good practices for blood establishments
- TRS 1060 Annex 3 WHO good manufacturing practices for excipients used in pharmaceutical products
- TRS 1060 Annex 2 WHO good practice considerations for the prevention and control of nitrosamines in pharmaceutical products
- TRS 1052 Annex 3 IAEA/WHO good manufacturing practices for in-house cold kits for radiopharmaceutical preparations
- TRS 1044 Annex 5 WHO good manufacturing practices for medicinal gases
- TRS 1044 Annex 2 WHO good manufacturing practices for sterile pharmaceutical products
- TRS 1044 Annex 6 WHO good practices for research and development facilities of pharmaceutical products
- TRS 1044 Annex 7 WHO good manufacturing practices for investigational products
- TRS 1044 Annex 3 IAEA/WHO guideline on good manufacturing practices for investigational radiopharmaceutical products
- TRS 1044 Annex 4 WHO guidelines on technology transfer in pharmaceutical manufacturing
- TRS 1033 Annex 3 Good manufacturing practices: water for pharmaceutical use
- TRS 1033 Annex 4 WHO guideline on data integrity
- TRS 1033 Annex 2 Points to consider when including health-based exposure limits (HBELs) in cleaning validation
- TRS 1025 Annex 2 IAEA/WHO good manufacturing practices for radiopharmaceutical products
- TRS 1025 Annex 6 Points to consider for manufacturers and inspectors: environmental aspects of manufacturing for the prevention of antimicrobial resistance
- TRS 1025 Annex 3 Production of water for injection by means other than distillation
- TRS 1019 Annex 2 WHO good manufacturing practices for heating, ventilation and air-conditioning systems for non-sterile pharmaceutical products (part 2): interpretation of guidelines
- TRS 1019 Annex 3 Good manufacturing practices: guidelines on validation
- TRS 1010 Annex 8 Guidelines on heating, ventilation and air-conditioning systems for non-sterile pharmaceutical products
- TRS 1010 Annex 1 WHO good manufacturing practices for the manufacture of herbal medicines
- TRS 996 Annex 3 WHO good manufacturing practices for biological products (jointly with the Expert Committee on Biological Standardization)
- TRS 992 Annex 4 General guidance on hold-time studies
- TRS 986 Annex 2 WHO good manufacturing practices for pharmaceutical products: main principles
- TRS 981 Annex 2 WHO guidelines on quality risk management
- TRS 957 Annex 2 WHO good manufacturing practices for active pharmaceutical ingredients (bulk drug substances)
- TRS 957 Annex 3 WHO good manufacturing practices for pharmaceutical products containing hazardous substances
- TRS 902 Annex 9 Guidelines on packaging for pharmaceutical products