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List of GMP guidelines used by PPB GMP inspectors

  1. WHO good manufacturing practices for medicinal gases. WHO Expert Committee on Specifications for Pharmaceutical Preparations. Fifty-sixth Report Geneva, World Health Organization, 2022 (WHO Technical Report Series, No. 1044), Annex 5.

https://www.who.int/publications/m/item/trs1044-annex5

 

  1. WHO good manufacturing practices for sterile pharmaceutical products. WHO Expert Committee on Specifications for Pharmaceutical Preparations. Fifty-sixth Report Geneva, World Health Organization, 2022 (WHO Technical Report Series, No. 1044), Annex 2.

https://www.who.int/publications/m/item/trs1044-annex2

 

  1. WHO good practices for research and development facilities of pharmaceutical products. WHO Expert Committee on Specifications for Pharmaceutical Preparations. Fifty-sixth Report Geneva, World Health Organization, 2022 (WHO Technical Report Series, No. 1044), Annex 6.

https://www.who.int/publications/m/item/trs1044-annex6

 

  1. WHO good manufacturing practices for investigational products. WHO Expert Committee on Specifications for Pharmaceutical Preparations. Fifty-sixth Report Geneva, World Health Organization, 2022 (WHO Technical Report Series, No. 1044), Annex 7.

https://www.who.int/publications/m/item/trs1044-annex7

 

  1. IAEA/WHO guidelines on good manufacturing practices for investigational radiopharmaceutical products. WHO Expert Committee on Specifications for Pharmaceutical Preparations. Fifty-sixth Report Geneva, World Health Organization, 2022 (WHO Technical Report Series, No. 1044), Annex 3.

https://www.who.int/publications/m/item/trs1044-annex3

 

  1. WHO guidelines on technology transfer in pharmaceutical manufacturing. WHO Expert Committee on Specifications for Pharmaceutical Preparations. Fifty-sixth Report Geneva, World Health Organization, 2022 (WHO Technical Report Series, No. 1044), Annex 4.

https://www.who.int/publications/m/item/trs1044-annex4

 

  1. WHO good manufacturing practices: water for pharmaceutical use. WHO Expert Committee on Specifications for Pharmaceutical Preparations. Fifty-fifth Report Geneva, World Health Organization, 2021 (WHO Technical Report Series, No. 1033), Annex 3.

https://www.who.int/publications/m/item/annex-3-trs-1033

 

  1. WHO Guidance on good data and record management practices. WHO Expert Committee on Specifications for Pharmaceutical Preparations. Fifty-fifth Report Geneva, World Health Organization, 2021 (WHO Technical Report Series, No. 1033), Annex 3.

https://www.who.int/publications/m/item/annex-4-trs-1033

 

  1. Points to consider when including Health Based Exposure Limits (HBELs) in cleaning validation. WHO Expert Committee on Specifications for Pharmaceutical Preparations. Fifty-fifth Report Geneva, World Health Organization, 2021 (WHO Technical Report Series, No. 1033), Annex 2.

https://www.who.int/publications/m/item/annex-2-trs-1033

 

  1. IAEA-WHO good manufacturing practices for radiopharmaceutical products. WHO Expert Committee on Specifications for Pharmaceutical Preparations. Fifty-fourth Report Geneva, World Health Organization, 2020 (WHO Technical Report Series, No. 1025), Annex 2.

https://www.who.int/publications/m/item/trs1025-annex2

 

  1. Points to consider for manufacturers and inspectors: environmental aspects of manufacturing for the prevention of antimicrobial resistance. WHO Expert Committee on Specifications for Pharmaceutical Preparations. Fifty-fourth ReportGeneva, World Health Organization, 2020 (WHO Technical Report Series, No. 1025), Annex 6.

https://www.who.int/publications/m/item/trs-1025-annex-6

 

  1. WHO production of water for injection by means other than distillation. WHO Expert Committee on Specifications for Pharmaceutical Preparations. Fifty-fourth Report Geneva, World Health Organization, 2020 (WHO Technical Report Series, No. 1025), Annex 2.

https://www.who.int/publications/m/item/trs-1025-annex-3-water-for-injection 

 

  1. WHO good manufacturing practices for heating, ventilation and air-conditioning systems for non-sterile pharmaceutical products (part 2): interpretation of guidelines. WHO Expert Committee on Specifications for Pharmaceutical Preparations. Fifty-third Report Geneva, World Health Organization, 2019 (WHO Technical Report Series, No. 1019), Annex 2.

https://www.who.int/publications/m/item/trs1019-annex2

 

  1. WHO good manufacturing practices guidelines on validation. WHO Expert Committee on Specifications for Pharmaceutical Preparations. Fifty-third Report Geneva, World Health Organization, 2019 (WHO Technical Report Series, No. 1019), Annex 3.

https://www.who.int/publications/m/item/trs1019-annex3

 

  1. WHO Guidelines on heating, ventilation and air-conditioning system for non-sterile pharmaceutical products. WHO Expert Committee on Specifications for Pharmaceutical Preparations. Fifty-second Report Geneva, World Health Organization, 2018 (WHO Technical Report Series, No. 1010), Annex 8 https://www.who.int/publications/m/item/Annex-8-trs-1010

 

  1. WHO good manufacturing practices for the manufacture of herbal medicines. WHO Expert Committee on Specifications for Pharmaceutical Preparations. Fifty-second Report Geneva, World Health Organization, 2018 (WHO Technical Report Series, No. 1010), Annex 2

https://www.who.int/publications/m/item/trs1010-annex2

 

  1. WHO good manufacturing practices for the manufacture of herbal medicines. WHO Expert Committee on Specifications for Pharmaceutical Preparations. Fifty-second Report Geneva, World Health Organization, 2018 (WHO Technical Report Series, No. 1010), Annex 1

https://www.who.int/publications/m/item/trs1010-annex1

 

  1. WHO good manufacturing practices for biological products (jointly with expert committee on Biological Standardization). WHO Expert Committee on Specifications for Pharmaceutical Preparations. Fiftieth Report Geneva, World Health Organization, 2016 (WHO Technical Report Series, No. 996), Annex 3

https://www.who.int/publications/m/item/trs996-annex3

 

  1. WHO General guidance on hold-time studies. WHO Expert Committee on Specifications for Pharmaceutical Preparations. Forty-Ninth Report Geneva, World Health Organization, 2015 (WHO Technical Report Series, No. 992), Annex 4

https://www.who.int/publications/m/item/trs992-annex4

 

  1. WHO good manufacturing practices for pharmaceutical products: Main principles. WHO Expert Committee on Specifications for Pharmaceutical Preparations. Forty-eight Report Geneva, World Health Organization, 2014 (WHO Technical Report Series, No. 986), Annex 2

https://www.who.int/publications/m/item/trs986-annex2

 

  1. WHO guidelines on quality risk management. WHO Expert Committee on Specifications for Pharmaceutical Preparations. Forty-Seventh Report Geneva, World Health Organization, 2013 (WHO Technical Report Series, No. 981), Annex 2

https://www.who.int/publications/m/item/trs981-annex2

 

  1. WHO good manufacturing practices for blood establishments (jointly with the Expert Committee on Biological Standardization). WHO Expert Committee on Specifications for Pharmaceutical Preparations. Forty-Seventh ReportGeneva, World Health Organization, 2011 (WHO Technical Report Series, No. 961), Annex 4

https://www.who.int/publications/m/item/trs961-annex4

 

  1. WHO good manufacturing practices for active pharmaceutical ingredients (bulk drug products). WHO Expert Committee on Specifications for Pharmaceutical Preparations. Forty-fourth Report. Geneva, World Health Organization, 2010 (WHO Technical Report Series, No. 957), Annex 2.

https://www.who.int/publications/m/item/annex-2-trs-957

 

  1. WHO Good Practices for Pharmaceutical Products Containing Hazardous Substances.WHO Expert Committee on Specifications for Pharmaceutical Preparations. Forty-fourth Report. Geneva, World Health Organization, 2010 (WHO Technical Report Series, No. 957), Annex 3.

https://www.who.int/publications/m/item/trs957-annex3

 

  1. WHO Guidelines on packaging for pharmaceutical products.WHO Expert Committee on Specifications for Pharmaceutical Preparations. Forty-fourth Report. Geneva, World Health Organization, 2002 (WHO Technical Report Series, No. 902), Annex 9

https://www.who.int/publications/m/item/annex-9-trs-902

 

  1. WHO Good manufacturing practices: supplementary guidelines for the manufacture of pharmaceutical excipients.WHO Expert Committee on Specifications for Pharmaceutical Preparations. Thirty-second Report. Geneva, World Health Organization, 1999 (WHO Technical Report Series, No. 885), Annex 5

https://www.who.int/publications/m/item/trs885-annex5

 

  1. WHO Good chromatography practices. WHO Expert Committee on Specifications for Pharmaceutical Preparations. Fifty-fourth report Geneva, World Health Organization, 2020 (WHO Technical Report Series, No. 1025), Annex 4

https://www.who.int/publications/m/item/trs1025-annex4

 

  1. WHO good practices for pharmaceutical quality control laboratories. WHO Expert Committee on Specifications for Pharmaceutical Preparations. Forty-eight Report Geneva, World Health Organization, 2010 (WHO Technical Report Series, No. 957), Annex 1

https://www.who.int/publications/m/item/trs957-annex1

 

  1. WHO Good practices for pharmaceutical microbiology laboratories. WHO Expert Committee on Specifications for Pharmaceutical Preparations. Fourth-six Report. Geneva, World Health Organization, 2011 (WHO Technical Report Series, No. 961), Annex 2

https://www.who.int/publications/m/item/trs961-annex2