WHO · TRS Annexes
WHO TRS annexes
Selected GMP and quality documents from the annexes of the WHO Expert Committee on Specifications for Pharmaceutical Preparations Technical Report Series (TRS), listed by publication date. These are the reference documents for WHO prequalification (PQ) and international procurement requirements. Always check the official source for legal status and the latest version.
- 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 1052 Annex 4 WHO good practices for pharmaceutical quality control laboratories
- TRS 1052 Annex 2 WHO good manufacturing practices for excipients used in pharmaceutical products
- 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 4 WHO good chromatography practices
- TRS 1025 Annex 2 IAEA/WHO good manufacturing practices for radiopharmaceutical products
- TRS 1025 Annex 5 Quality system requirements for national good manufacturing practice inspectorates
- TRS 1025 Annex 7 Good storage and distribution practices for medical 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 1010 Annex 9 WHO good practices for desk assessment of compliance with good manufacturing practices, good laboratory practices and good clinical practices for medical products regulatory decisions
- TRS 1010 Annex 2 WHO good manufacturing practices for the manufacture of herbal medicines
- TRS 1010 Annex 10 WHO guidelines on stability testing of active pharmaceutical ingredients and finished pharmaceutical products
- TRS 996 Annex 4 Guidance on good manufacturing practices: inspection report, including Appendix 1: Model certificate of good manufacturing practices (revision)
- TRS 996 Annex 6 WHO good trade and distribution practices for pharmaceutical starting materials
- 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 961 Annex 14 WHO guidelines for drafting a site master file
- TRS 961 Annex 4 WHO good manufacturing practices for blood establishments (jointly with the Expert Committee on Biological Standardization)
- TRS 961 Annex 2 WHO good practices for pharmaceutical microbiology laboratories
- 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 957 Annex 1 WHO good practices for pharmaceutical quality control laboratories
- TRS 929 Annex 4 WHO guidelines for sampling of pharmaceutical products and related materials
- TRS 902 Annex 9 Guidelines on packaging for pharmaceutical products
- TRS 902 Annex 7 WHO guidelines on pre-approval inspections
- TRS 885 Annex 5 WHO good manufacturing practices for the manufacture of pharmaceutical excipients
- TRS 823 Annex 2 Inspection of pharmaceutical manufacturers
