WHO good manufacturing practices

Production

Good manufacturing practice (GMP) is that part of quality assurance which ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the marketing authorization. GMP is aimed primarily at diminishing the risks inherent in any pharmaceutical production, which may broadly be categorized in two groups: cross contamination/mix-ups and false labelling. Above all, manufacturers must not place patients at risk due to inadequate safety, quality or efficacy; for this reason, risk assessment has come to play an important role in WHO quality assurance guidelines.

WHO good manufacturing practices

• Quality assurance of pharmaceuticals: a compendium of guidelines and related materials
  pdf, 5.51Mb
  Volume 2, 2nd updated edition
• WHO good manufacturing practices: main principles for pharmaceutical products
  pdf, 278kb
  Annex 3, WHO Technical Report Series 961, 2011
• Frequently Asked Questions: Good Manufacturing Practice (GMP) in Pharmaceutical Practice
• Active pharmaceutical ingredients (bulk drug substances)
  pdf, 206kb
  Annex 2, WHO Technical Report Series 957, 2010
• Pharmaceutical excipients [pdf 7Mb]
  pdf, 1.02Mb
  Annex 5, WHO Technical Report Series 885, 1999
• WHO good manufacturing practices for sterile pharmaceutical products
  pdf, 171kb
  Annex 6, WHO Technical Report Series 961, 2011
• Biological products
  pdf, 549kb
  Annex 3, WHO Technical Report Series 822, 1992
• WHO good manufacturing practices for blood establishments (jointly with the Expert Committee on Biological Standardization)
  pdf, 322kb
  Annex 4, WHO Technical Report Series 961, 2011
• Pharmaceutical products containing hazardous substances
  pdf, 146kb
  Annex 3 WHO Technical Report Series 957, 2010
• Investigational pharmaceutical products for clinical trials in humans [pdf 4Mb]
  pdf, 564kb
  Annex 7, WHO Technical Report Series 863, 1996
• Herbal medicinal products
  pdf, 119kb
  Annex 3, WHO Technical Report Series 937, 2006
• Radiopharmaceutical products
  pdf, 95kb
  Annex 3, WHO Technical Report Series 908, 2003
• Water for pharmaceutical use
  pdf, 329kb
  Annex 2, WHO Technical Report Series 970, 2012
• WHO guidelines on good manufacturing practices for heating, ventilation and air-conditioning systems for non-sterile pharmaceutical dosage forms
  pdf, 396kb
  Annex 5, WHO Technical Report Series 961, 2011
• Validation
  pdf, 272kb
  Annex 4, WHO Technical Report Series 937, 2006

Risk analysis

• Application of Hazard Analysis and Critical Control Point (HACCP) Methodology in Pharmaceuticals
  pdf, 103kb
  Annex 7, WHO Technical Report Series 908, 2003

Technology transfer

• WHO guidelines on transfer of technology in pharmaceutical manufacturing
  pdf, 156kb
  Annex 7, WHO Technical Report Series 961, 2011

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)

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