Guidelines: Norms and Standards for Pharmaceuticals
The norms and standards for pharmaceuticals developed by WHO are prepared through a vast global consultative process involving WHO Member States, national regulatory authorities and international agencies; in consultation with the WHO Expert Advisory Panel on the International Pharmacopoeia and Pharmaceutical Preparations, specialists from industry, national institutions, nongovernmental organizations, and so on. These draft guidelines are evaluated during the meetings of the WHO Expert Committee on Specifications for Pharmaceutical Preparations and, if found suitable, are thereafter adopted as international standards.
This web page links to all current WHO norms and standards for pharmaceuticals guidelines which are grouped into (1) development, (2) production, (3) distribution, (4) inspection, (5) quality control, (6) regulatory standards and (7) specific texts for prequalification of medicines.
The guidelines under development/for comment are under working documents in public consultation.
Quality assurance of pharmaceuticals: a compendium of guidelines and related materials

Quality assurance of pharmaceuticals: a compendium of guidelines and related materials: volume 1: Good...
This publication represents a significant achievement in our ongoing effort to ensure that everyone can reach the highest possible level of health. Over...

Quality assurance of pharmaceuticals: a compendium of guidelines and related materials: volume 2: Good...
This publication guides the manufacturing and quality control of pharmaceuticals, vaccines and other biologicals, and other medical products...
Guidelines
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TRS 1025 - Annex 6: Points to consider for manufacturers and inspectors: environmental aspects of manufacturing for the prevention of antimicrobial resistance
TRS 1010 - Annex 9: WHO good practices for desk assessment of compliance with good manufacturing practices, good laboratory practices and good clinical practices for medical products regulatory decisions
TRS 1025 - Annex 9: World Health Organization/United Nations Population Fund Prequalification Programme guidance for contraceptive devices: male latex condoms, female condoms and intrauterine devices
TRS 966 - Annex 8: WHO collaborative procedure between the WHO prequalification team and national regulatory authorities in the assessment and accelerated national registration of WHO-prequalified pharmaceutical products and vaccines
TRS 1003 - Annex 3: Prequalification of quality control laboratories: procedure for assessing the acceptability, in principle, of quality control laboratories for use by United Nations agencies
TRS 970 - Annex 4: Guidelines on submission of documentation for a multisource (generic) finished pharmaceutical product for the WHO Prequalification of Medicines Programme: quality part