WHO has formulated international regulatory standards, which include stability, packaging, storage, and bioequivalence. Care must be taken to ensure that active pharmaceutical compounds remain stable and unaffected by packaging materials or storage conditions.
WHO Guidelines for Pharmaceuticals
Stability
WHO guidelines on stability testing of active pharmaceutical ingredients and finished pharmaceutical products
Annex 10: WHO Technical Report Series 1010, 2018
Stability testing of active pharmaceutical ingredients and finished pharmaceutical products: Stability conditions for WHO Member States by Region
Appendix 1 - Annex 2: WHO Technical Report Series 953, 2018
Others
WHO general guidance on variations to multi source pharmaceutical products
Annex 10: WHO Technical Report Series 966, 2016
WHO good review practices for national and regional regulatory authorities
Annex 9: WHO Technical Report Series 992, 2015
WHO guidelines on submission of documentation for a multi source (generic) finished product: Quality part
Annex 6: WHO Technical Report Series 986, 2014
WHO recommendations for quality requirements when plant‑derived artemisinin is used as a starting material in the production of antimalarial active pharmaceutical ingredients
Annex 6: WHO Technical Report Series 992, 2015
WHO guidelines for drafting a site master file
Annex 14: WHO Technical Report Series 961, 2011
WHO guidelines for the preparation of a contract research organization master file
Annex 7: WHO Technical Report Series 957, 2010
WHO guidelines on active pharmaceutical ingredient master file procedure
Annex 4: WHO Technical Report Series 948, 2008
WHO guidelines for the registration of fixed-dose combination medicinal products
Annex 5: WHO Technical Report Series 948, 2008
UNFPA-WHO technical specifications for male latex condoms
Annex 10: WHO Technical Report Series 1025, 2020
UNFPA-WHO specifications for plain lubricants
Annex 11: WHO Technical Report Series 1025, 2020
WHO guidelines for sampling of pharmaceutical products and related materials
Annex 5: WHO Technical Report Series 929, 2005
WHO guidelines on packaging for pharmaceutical products
Annex 9: WHO Technical Report Series 902, 2002
WHO certification scheme on the quality of pharmaceutical products moving in international commerce
WHO pharmaceutical starting materials certification scheme (SMACS): guidelines on implementation
Annex 3: WHO Technical Report Series 917, 2003
WHO guidelines on import procedures for medical products
Annex 5: WHO Technical Report Series 1019, 2019
WHO good practices for desk assessment of compliance with good manufacturing practices, good laboratory practices and good clinical practices for medical products regulatory decisions
Annex 9: WHO Technical Report Series 1010, 2018
IAEA - WHO good manufacturing practices for radiopharmaceutical products
Annex 2: WHO Technical Report Series 1025, 2020
Read also: List of ICH Guidelines for Pharmaceutical Industry
