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

Application of Hazard Analysis and Critical Control Point (HACCP) Methodology in Pharmaceuticals [pdf 632kb]
Annex 7, WHO Technical Report Series 908, 2003

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:

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

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

  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

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

Basic tests for drugs : pharmaceutical substances, medicinal plant materials and dosage forms [pdf 2.9Mb]

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]

International Pharmacopoeia: Monographs development

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

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

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

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

  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