WHO GMP
Production:
Quality assurance of pharmaceuticals: a compendium of guidelines and related materials [pdf 4.82Mb]
Volume 2, 2nd updated edition
Good Manufacturing Practices for Pharmaceutical Products: Main Principle [pdf 632kb]
Annex 4, WHO Technical Report Series 908, 2003
Good manufacturing practices: requirement for the sampling of starting materials (amendment)
Annex 2, WHO Technical Report Series 929, 2005
Frequently Asked Questions: Good Manufacturing Practice (GMP) in Pharmaceutical Practice
Active pharmaceutical ingredients (bulk drug substances)
Annex 2, WHO Technical Report Series 957, 2010
Pharmaceutical excipients [pdf 7Mb]
Annex 5, WHO Technical Report Series 885, 1999
Sterile pharmaceutical products [pdf 1Mb]
Annex 4, WHO Technical Report Series 957, 2010
Biological products [pdf 1.5Mb]
Annex 3, WHO Technical Report Series 834, 1993
Pharmaceutical products containing hazardous substances [pdf 1Mb]
Annex 3 WHO Technical Report Series 957, 2010
Investigational pharmaceutical products for clinical trials in humans [pdf 4Mb]
Annex 7, WHO Technical Report Series 863, 1996
Herbal medicinal products [pdf 4Mb]
Annex 3, WHO Technical Report Series 937, 2006
Radiopharmaceutical products [pdf 632kb]
Annex 3, WHO Technical Report Series 908, 2003
Water for pharmaceutical use
Annex 3, WHO Technical Report Series 929, 2005
Heating, ventilation and air-conditioning systems for non-sterile pharmaceutical dosage forms
Annex 2, WHO Technical Report Series 937, 2006
Validation
Annex 4, WHO Technical Report Series 937, 2006
Risk analysis
Application of Hazard Analysis and Critical Control Point (HACCP) Methodology in Pharmaceuticals [pdf 632kb]
Annex 7, WHO Technical Report Series 908, 2003
Training materials
WHO Basic Training Modules on GMP
(Includes an introduction, resource and study pack for trainers)
WHO supplementary training modules on GMP
(Includes drafts of GMP for Validation, Water, and Air Handling Systems)
Distribution:
Starting materials
Control and safe trade of starting materials for pharmaceutical products
Good trade and distribution practices for pharmaceutical starting materials [pdf 83kb]
Annex 2, WHO Technical Report Series 917, 2003
WHO pharmaceutical starting materials certification scheme (SMACS): guidelines on implementation [pdf 100kb]
Annex 3, WHO Technical Report Series 917, 2003
Finished Products
Good distribution practices for pharmaceutical products
Annex 5, WHO Technical Report Series 957, 2010
Certification scheme on the quality of pharmaceutical products moving in international commerce
Procurement
Procedure for assessing the acceptability, in principle, of procurement agencies for use by United Nations agencies [pdf 62kb]
Annex 6, WHO Technical Report Series 917, 2003
Guidelines on the requalification of prequalified dossiers
Annex 6, WHO Technical Report Series 957, 2010
Guidelines for the preparation of a procurement agency information file [pdf 41kb]
Annex 7, WHO Technical Report Series 917, 2003
Interim guidelines for the assessment of a procurement agency [pdf 136kb]
Annex 8 (based on the draft model quality assurance system for procurement agencies), WHO Technical Report Series 917, 2003
A model quality assurance system for procurement agencies (Recommendations for quality assurance systems focusing on prequalifi cation of products and manufacturers, purchasing, storage and distribution of pharmaceutical products)
Annex 6, WHO Technical Report Series 937, 2006
Storage
Guide to good storage practices for pharmaceuticals [pdf 632kb]
Annex 9, WHO Technical Report Series 908, 2003
Inspections
Quality assurance of pharmaceuticals: a compendium of guidelines and related materials [pdf 4.82Mb]
Volume 2, 2nd updated edition
Quality system requirements for national GMP inspectorates [pdf 1Mb]
Annex 8, WHO Technical Report Series 902, 2002
Pre-approval inspections [pdf 1Mb]
Annex 7, WHO Technical Report Series 902, 2002
Inspection of pharmaceutical manufacturers [pdf 6.4Mb]
Annex 2, WHO Technical Report Series 823, 1992
Inspection of drug distribution channels [pdf 7Mb]
Annex 6, WHO Technical Report Series 885, 1999
Guidance on GMP: Inspection Report
Annex 6, WHO Technical Report Series 908, 2003
Model Certificate of GMP [pdf 632kb]
Annex 5, WHO Technical Report Series 908, 2003
Quality Control
Screening tests
Pharmacopoeia and International Reference Standards
The International Pharmacopoeia (Ph. Int.) - Publication
Index of national, regional and international pharmacopoeias [pdf 149kb]
Lists of available International Chemical Reference Substances and International Infrared Reference Spectra [pdf 60kb]
Annex 1, WHO Technical Report Series 953, 2009
Recommendations on Risk of Transmitting Animal Spongiform Encephalopathy Agents via Medicinal Products [pdf 632kb]
Annex 1, WHO Technical Report Series 908, 2003
The International Pharmacopoeia: revised concepts and future perspectives [pdf 632kb]
Annex 2, WHO Technical Report Series 908, 2003
The International Pharmacopoeia – related substances tests: dosage form monographs guidance notes
Annex 1, WHO Technical Report Series 943, 2007
General guidelines for the establishment, maintenance and distribution of chemical reference substances
Annex 3, WHO Technical Report Series 943, 2007
PowerPoint presentation on the International Pharmacopoeia [pdf 1.07Mb]
Monographs for International Pharmacopoeia
International Pharmacopoeia: Monographs development
Analysis of Samples
Considerations for requesting analyses of drug samples [pdf 1Mb]
Annex 4, WHO Technical Report Series 902, 2002
Model certificate of analysis [pdf 1Mb]
Annex 10, WHO Technical Report Series 902, 2002
Laboratory Guidelines
Good practices for pharmaceutical quality control laboratories
Annex 1, WHO Technical Report Series 957, 2010
Quality Control Training Modules
Procedure for assessing the acceptability, in principle, of quality control laboratories for use by United Nations agencies [pdf 62kb]
Annex 4, WHO Technical Report Series 917, 2003
Guidelines for preparing a laboratory information file [pdf 42kb]
Annex 5, WHO Technical Report Series 917, 2003
Plant materials
Quality control methods for medicinal plant materials [pdf 1.7Mb]
Regulatory Standards
Stability
Stability Testing of Pharmaceutical Products in a Global Environment [pdf 198kb]
Dr Sabine Kopp reports on the development of World Health Organization policy on stability testing.
"Article from The Regulatory Affairs Journal"
Stability testing of active pharmaceutical ingredients and finished pharmaceutical products
Annex 2, WHO Technical Report Series 953, 2009
Interchangeability
Multisource (generic) pharmaceutical products: guidelines on registration requirements to establish interchangeability
Annex 7, WHO Technical Report Series 937, 2006
Proposal to waive in vivo bioequivalence requirements for WHO Model List of Essential Medicines immediate-release, solid oral dosage forms
Annex 8, WHO Technical Report Series 937, 2006
For further information on Biowaiver
Additional guidance for organizations performing in vivo bioequivalence studies
Annex 9, WHO Technical Report Series 937, 2006
Guidelines for registration of fixed-dose combination medicinal products
Annex 5, WHO Technical Report Series 929, 2005
Chinese the corrected version of Annex 5 — TRS 929 [pdf 371kb]
Guidance on the selection of comparator pharmaceutical products for equivalence assessment of interchangeable multisource (generic) products
Annex 11, WHO Technical Report Series 902, 2002
INTERNATIONAL NONPROPRIETARY NAMES (INN)
International Nonproprietary Names for biological and biotechnological substances: a review
Annex 5, WHO Technical Report Series 948, 2008
Others
Procedure for prequalification of pharmaceutical products
Annex 3, WHO Technical Report Series 953, 2009
Guidelines on the requalification of prequalified dossiers
Annex 6, WHO Technical Report Series 957, 2010
Procedure for assessing the acceptability, in principle, of active pharmaceutical ingredients for use in pharmaceutical products
Annex 4, WHO Technical Report Series 953, 2009
Prequalification of quality control laboratories. Procedure for assessing the acceptability, in principle, of quality control laboratories for use by United Nations agencies
Annex 5, WHO Technical Report Series 943, 2007
Guidelines for the preparation of a contract research organization master file
Annex 7, WHO Technical Report Series 957, 2010
Guidelines on active pharmaceutical ingredient master file procedure
Annex 4, WHO Technical Reports Series 948, 2008
Procedure for Assessing the acceptability, in principle of male latex condoms for purchase by United Nations agencies
Annex 2, WHO Technical Reports Series 948, 2008
Procedure for Assessing the acceptability, in principle of TCU 380A intrauterine devices for purchase by United Nations agencies
Annex 3, WHO Technical Report Series, No. 948, 2008
Guidance on variations to a prequalified product dossier
Annex 6, WHO Technical Report Series 943, 2007
Guidelines on packaging for pharmaceutical products [pdf 1Mb]
Annex 9, WHO Technical Report Series 902, 2002
Guidelines on import procedures for pharmaceutical products
Annex 12, WHO Technical Series 863, 1996
WHO guidelines for sampling of pharmaceutical products and related materials
Annex 4, WHO Technical Report Series 929, 2005
Counterfeit medicines
Medicines regulatory support