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
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WHO good manufacturing practices for pharmaceutical products: main principles
pdf, 285kb
Annex 2, WHO Technical Report Series 986, 2014 -
French version
pdf, 822kb - Frequently Asked Questions: Good Manufacturing Practice (GMP) in Pharmaceutical Practice
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Active pharmaceutical ingredients (bulk drug substances)
pdf, 206kb
Annex 2, WHO Technical Report Series 957, 2010 -
French version
pdf, 636kb - Active pharmaceutical ingredients - bulk drug substances: Additional clarifications and explanations
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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 -
WHO good manufacturing practices for biological products
pdf, 236kb
Annex 3, WHO Technical Report Series 996, 2016 -
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 -
French version
pdf, 454kb -
Investigational pharmaceutical products for clinical trials in humans [pdf 4Mb]
pdf, 564kb
Annex 7, WHO Technical Report Series 863, 1996 -
Herbal medicinal products
pdf, 182kb
Annex 2, WHO Technical Report Series 1010, 2018 -
International Atomic Energy Agency and World Health Organization guideline on good manufacturing practices for radiopharmaceutical products
Annex 2, WHO Technical Report Series 1025, 2020 -
Water for pharmaceutical use (English version)
pdf, 329kb
Annex 2, WHO Technical Report Series 970, 2012 -
French version
pdf, 377kb - Japanese version pdf, 537.2 kB
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Production of water for injection by means other than distillation
Annex 3, WHO Technical Report Series 1025, 2020 -
WHO guidelines on good manufacturing practices for heating, ventilation and air-conditioning systems for non-sterile pharmaceutical dosage forms
pdf, 164kb
Annex 8, WHO Technical Report Series 1010, 2018 -
Part 2: Interpretation of Guidelines on heating, ventilation and air-conditioning systems for non-sterile pharmaceutical products
pdf, 1.79Mb
Annex 2, WHO Technical Report Series 1019, 2019 -
Guidelines on validation
pdf, 1.00Mb
Annex 3, WHO Technical Report Series 1019, 2019
Risk analysis
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Application of Hazard Analysis and Critical Control Point (HACCP) Methodology in Pharmaceuticals
pdf, 103kb
Annex 7, WHO Technical Report Series 908, 2003 -
WHO guidelines on quality risk management
Annex 2, WHO Technical Report Series 981, 2013 -
Points to consider for manufacturers and inspectors: environmental aspects of manufacturing for the prevention of antimicrobial resistance
Annex 6, WHO Technical Report Series 1025, 2020
Technology transfer
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WHO guidelines on transfer of technology in pharmaceutical manufacturing
pdf, 156kb
Annex 7, WHO Technical Report Series 961, 2011
Training materials
Desk assessment
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Guidance on good practices for desk assessment of compliance with good manufacturing practices, good laboratory practices and good clinical practices for medical products regulatory decisions
pdf, 212kb
Annex 9, WHO Technical Report Series 1010, 2018