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List of guidelines and guidance for pharmaceuticals
Category Guideline TRS Annex Year Available
languages
All guidelines Procedure for the development of World Health 1019 Annex 1 2019
Organization medicines quality assurance guidelines
Development Development of paediatric medicines: points to consider 970 Annex 5 2012  
in formulation
Development Pharmaceutical development of multisource (generic) 970 Annex 3 2012  
finished pharmaceutical products: points to consider
Distribution Pharmacy services
Distribution Joint FIP/WHO guidelines on good pharmacy practice: 961 Annex 8 2011  
standards for quality of pharmacy services
Distribution Compounding
Distribution FIP-WHO technical guidelines: Points to consider in the 996 Annex 2 2016  
provision by health-care professionals of children-specific
preparations that are not available as authorized products
Distribution Monitoring
Distribution/ Guidelines on the conduct of surveys of the quality of 996 Annex 7 2016  
quality control medicines
Distribution Import & Export Controls
Distribution Good trade and distribution practices for pharmaceutical 996 Annex 6 2016  
starting materials
 Category Guideline TRS Annex Year Available
languages
Distribution Import & Export Controls (continued)
Distribution/ Guidelines on import procedures for medical products 1019 Annex 5 2019  
regulatory standards
Distribution/ WHO pharmaceutical starting materials certification 917 Annex 3 2003  
regulatory standards scheme (SMACS): guidelines on implementation
Distribution/ Guidelines on the implementation of the WHO 1033 Annex 9 2021  
regulatory standards certification scheme on the quality of pharmaceutical
products moving in international commerce
Distribution Procurement
Distribution Procedure for assessing the acceptability, in principle, of 917 Annex 6 2003
procurement agencies for use by United Nations agencies
Distribution Model quality assurance system for procurement agencies 986 Annex 3 2014 EN
Distribution Système modèle d’assurance de la qualité pour les 986 Annex 3 2014 FR
agences d’approvisionnement
Distribution Примерная система обеспечения качества для 986 Приложение 3 2014 RU
закупочных агентств
Distribution Interagency finished pharmaceutical product 986 Appendix 6 2014  
questionnaire based on the model quality assurance to Module VI,
system for procurement agencies Annex 3
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Category Guideline TRS Annex Year Available
languages
Distribution Procurement (continued)
Distribution Assessment tool based on the model quality assurance 986 Annex 4 2014 EN
system for procurement agencies: aide‑memoire for
inspection
Distribution Système modèle d’assurance de la qualité pour les 986 Annex 4 2014 FR
agences d’approvisionnement: aide-mémoire pour les
inspections
Distribution Инструмент оценки на основе примерной системы 986 Приложение 4 2014 RU
обеспечения качества для закупочных агентств:
памятка для инспекции
Distribution Storage
Distribution Good storage and distribution practices for medical 1025 Annex 7 2020  
products
Distribution Points to consider for setting the remaining shelf-life of 1025 Annex 8 2020  
medical products upon delivery
Distribution Model guidance for the storage and transport of time- 961 Annex 9 2011  
and temperature-sensitive pharmaceutical products
Distribution Technical supplements to Model guidance for the 992 Annex 5 2015  
storage and transport of time- and temperature-sensitive
pharmaceutical products
Distribution Technical supplements to WHO Technical Report Series 992 Annex 5 2015  
No. 961, 2011: introduction to the technical supplements
 Category Guideline TRS Annex Year Available
languages
Distribution Storage (continued)
Distribution Supplement 1: Selecting sites for storage facilities 992 Annex 5 2015  
Distribution Supplement 2: Design and procurement of storage facilities 992 Annex 5 2015  
Distribution Supplement 3: Estimating the capacity of storage facilities 992 Annex 5 2015  
Distribution Supplement 4: Building security and fire protection 992 Annex 5 2015  
Distribution Supplement 5: Maintenance of storage facilities 992 Annex 5 2015  
Distribution Supplement 6: Temperature and humidity monitoring 992 Annex 5 2015  
systems for fixed storage areas
Distribution Supplement 7: Qualification of temperature-controlled 992 Annex 5 2015  
storage areas
Distribution Supplement 8: Temperature mapping of storage areas 992 Annex 5 2015  
Distribution Supplement 9: Maintenance of refrigeration equipment 992 Annex 5 2015  
Distribution Supplement 10: Checking the accuracy of temperature 992 Annex 5 2015  
control and monitoring devices
Distribution Supplement 11: Qualification of refrigerated road vehicles 992 Annex 5 2015  
Distribution Supplement 12: Temperature-controlled transport 992 Annex 5 2015  
operations by road and by air
Distribution Supplement 13: Qualification of shipping containers 992 Annex 5 2015  
Distribution Supplement 14: Transport route profiling qualification 992 Annex 5 2015  
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Category Guideline TRS Annex Year Available
languages
Distribution Storage (continued)
Distribution Supplement 15: Temperature and humidity monitoring 992 Annex 5 2015  
systems for transport operations
Distribution Supplement 16: Environmental management of 992 Annex 5 2015  
refrigeration equipment
Inspection
Inspection Guidance on good manufacturing practices: inspection 996 Annex 4 2016  
report.
Inspection Quality management system requirements for national 1025 Annex 5 2020  
inspectorates
Inspection Guidelines on pre-approval inspections 902 Annex 7 2002  
Inspection Provisional guidelines on the inspection of 823 Annex 2 1992  
pharmaceutical manufacturers
Inspection Guidance on good practices for desk assessment of 1010 Annex 9 2018  
compliance with good manufacturing practices, good
laboratory practices and good clinical practices for
medical products regulatory decisions
Production WHO good manufacturing practices
Production General guidance on hold-time studies 992 Annex 4 2015  
Production WHO guidelines for drafting a site master file 961 Annex 14 2011  
 Category Guideline TRS Annex Year Available
languages
Production WHO good manufacturing practices (continued)
Production WHO good manufacturing practices for pharmaceutical 986 Annex 2 2014 EN
products: main principles
Production Bonnes pratiques de fabrication de l’OMS des produits 986 Annex 2 2014 FR
pharmaceutiques: Grands principes
Production WHO good manufacturing practices for active 957 Annex 2 2010 EN
pharmaceutical ingredients
Production Bonnes pratiques de fabrication de l’OMS pour les 957 Annex 2 2010 FR
substances actives pharmaceutiques
Production Good manufacturing practices: supplementary guidelines 885 Annex 5 1999  
for the manufacture of pharmaceutical excipients
Production WHO good manufacturing practices for sterile 961 Annex 6 2011  
pharmaceutical products
Production WHO good manufacturing practices for biological 996 Annex 3 2016  
products [jointly with the Expert Committee on Biological
Standardization]
Production WHO guidelines on good manufacturing practices for 961 Annex 4 2011  
blood establishments [jointly with the Expert Committee
on Biological Standardization]
Production WHO good manufacturing practices for pharmaceutical 957 Annex 3 2010 EN
products containing hazardous substances
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Category Guideline TRS Annex Year Available
languages
Production WHO good manufacturing practices (continued)
Production Bonnes pratiques de fabrication de l’OMS pour les 957 Annex 3 2010 FR
produits pharmaceutiques contenant des substances
dangereuses
Production Good manufacturing practices: supplementary 863 Annex 7 1996  
guidelines for the manufacture of investigational
pharmaceutical products for clinical trials in humans
Production Guidelines on good manufacturing practices for the 1010 Annex 2 2018  
manufacture of herbal medicines
Production WHO guidelines on good herbal processing practices 1010 Annex 1 2018  
for herbal medicines
Production/ International Atomic Energy Agency and World Health 1025 Annex 2 2020  
regulatory standards Organization guideline on good manufacturing
practices for radiopharmaceutical products
Production Good manufacturing practices: water for 1033 Annex 3 2021  
pharmaceutical use
Production Production of water for injection by means other than 1025 Annex 3 2020  
distillation
Production Guidelines on heating, ventilation and air-conditioning 1010 Annex 8 2018  
systems for non-sterile pharmaceutical products
[Part 1]
 Category Guideline TRS Annex Year Available
languages
Production WHO good manufacturing practices (continued)
Production Guidelines on heating, ventilation and air-conditioning 1019 Annex 2 2019  
systems for non-sterile pharmaceutical products.
Part 2: Interpretation of guidelines
Production Good manufacturing practices: guidelines on validation 1019 Annex 3 2019  
Production Points to consider when including health-based 1033 Annex 2 2021  
exposure limits (HBELs) in cleaning validation
Production Risk analysis
Production/ WHO guidelines on quality risk management 981 Annex 2 2013  
regulatory standards
Production/ Points to consider for manufacturers and inspectors: 1025 Annex 6 2020  
inspection environmental aspects of manufacturing for the
prevention of antimicrobial resistance
Production Technology transfer
Production WHO guidelines on transfer of technology in 961 Annex 7 2011  
pharmaceutical manufacturing
Production Data management
Production/ Guideline on data integrity 1033 Annex 4 2021  
distribution
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Category Guideline TRS Annex Year Available
languages
Quality control Laboratory guidelines
Quality control WHO good practices for pharmaceutical quality control 957 Annex 1 2010  
laboratories
Quality control WHO good practices for pharmaceutical microbiology 961 Annex 2 2011  
laboratories
Quality control Good chromatography practices 1025 Annex 4 2020  
Quality control WHO guidelines for preparing a laboratory information 961 Annex 13 2011  
file
Quality control Screening tests
Quality control Basic tests for drugs: pharmaceutical substances, https://apps.who.int/iris/bitstream/handle/​
medicinal plant materials and dosage forms 10665/42020/9241545135.pdf?sequence=1
Quality control Analysis of samples
Quality control WHO guidelines for sampling of pharmaceutical products 929 Annex 4 2005  
and related materials
Quality control Considerations for requesting analysis of medicines 1010 Annex 3 2018  
samples
Quality control Model certificate of analysis 1010 Annex 4 2018  
Quality control WHO guidance on testing of “suspect” falsified medicines 1010 Annex 5 2018  
 Category Guideline TRS Annex Year Available
languages
Quality control Plant materials
Quality control Quality control methods for medicinal plant materials https://apps.who.int/iris/bitstream/handle/​
10665/41986/9241545100.pdf?sequence=1
Quality control WHO guidelines for selecting marker substances of herbal 1003 Annex 1 2017  
origin for quality control of herbal medicines
Quality control Recommendations for quality requirements when 992 Annex 6 2015  
plantderived artemisinin is used as a starting material
in the production of antimalarial active pharmaceutical
ingredients
Quality control Pharmacopoeias
Quality control Good pharmacopoeial practices 996 Annex 1 2016  
Quality control Good pharmacopoeial practices: Chapter on monographs 1010 Annex 6 2018  
for compounded preparations
Quality control Good pharmacopoeial practices: Chapter on monographs 1010 Annex 7 2018  
on herbal medicines
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Category Guideline TRS Annex Year Available
languages
Quality control The International Pharmacopoeia and International Reference Standards
Quality control The International Pharmacopoeia https://www.who.int/teams/health-product-
policy-and-standards/standards-and-
specifications/norms-and-standards-for-
pharmaceuticals/pharmacopoeia
Quality control Procedure for the elaboration, revision and omission 1025 Annex 1 2020  
of monographs and other texts for The International
Pharmacopoeia
Quality control The International Pharmacopoeia: revised concepts and 1003 Annex 2 2017  
future perspectives
Quality control Updating mechanism for the section on 992 Annex 2 2015  
radiopharmaceuticals in The International Pharmacopoeia
Quality control The International Pharmacopoeia – related substances 943 Annex 1 2007  
tests: dosage form monographs guidance notes
Quality control WHO International Chemical Reference Substances (ICRS): https://www.edqm.eu/en/WHO-ICRS-
purposes and use Reference-Substances-1393.html
Quality control Release procedure for International Chemical Reference 981 Annex 1 2013  
Substances
Quality control General guidelines for the establishment, maintenance 943 Annex 3 2007  
and distribution of chemical reference substances
Quality control Recommendations on risk of transmitting animal 908 Annex 1 2003  
spongiform encephalopathy agents via medicinal products
 Category Guideline TRS Annex Year Available
languages
Regulatory standards Stability
Regulatory standards Stability testing of active pharmaceutical ingredients and 1010 Annex 10 2018  
finished pharmaceutical products
Regulatory standards Stability testing of active pharmaceutical ingredients and https://cdn.who.int/media/docs/default-source/
finished pharmaceutical products: Stability conditions for medicines/norms-and-standards/guidelines/
WHO Member States by region: (update of March 2021) regulatory-standards/trs953-annex2-
appendix1-stability-conditions-table-2018.pdf?
sfvrsn=74032aec_12&download=true
Regulatory standards Clinical trials
Regulatory standards Guidelines for good clinical practice (GCP) for trials on 850 Annex 3 1995
pharmaceutical products
Regulatory standards Interchangeability
Regulatory standards Multisource (generic) pharmaceutical products: guidelines 1003 Annex 6 2017  
on registration requirements to establish interchangeability
Regulatory standards WHO “Biowaiver List”: proposal to waive in vivo 1025 Annex 12 2020  
bioequivalence requirements for WHO Model List of
Essential Medicines immediate-release, solid oral dosage
forms
Regulatory standards WHO “Biowaiver List”: proposal to waive in vivo 1033 Annex 8 2021  
bioequivalence requirements for WHO Model List of
Essential Medicines immediate-release, solid oral dosage
forms
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Category Guideline TRS Annex Year Available
languages
Regulatory standards Interchangeability (continued)
Regulatory standards Protocol to conduct equilibrium solubility experiments for 1019 Annex 4 2019  
the purpose of Biopharmaceutics Classification System-
based classification of active pharmaceutical ingredients
for biowaiver
Regulatory standards Guidance for organizations performing in vivo 996 Annex 9 2016  
bioequivalence studies
Regulatory standards General background notes on the list of international 1003 Annex 5 2017  
comparator pharmaceutical products
Regulatory standards Guidance on the selection of comparator pharmaceutical 992 Annex 8 2015  
products for equivalence assessment of interchangeable
multisource (generic) products
Regulatory standards List of international comparator products (September https://cdn.who.int/media/docs/default-source/
2016) medicines/norms-and-standards/guidelines/
regulatory-standards/list-int-comparator-prods-
after-public-consult30-9.xlsx?sfvrsn=3c9ec04b_2
Regulatory standards Medical devices
Regulatory standards WHO Global Model Regulatory Framework for Medical 1003 Annex 4 2017  
Devices including in vitro diagnostic medical devices
Regulatory standards World Health Organization/United Nations Population 1033 Annex 7 2021  
Fund guidance on conducting post-market surveillance
of condoms
 Category Guideline TRS Annex Year Available
languages
Regulatory standards Medical devices (continued)
Regulatory standards World Health Organization/United Nations Population 1025 Annex 10 2020  
Fund technical specifications for male latex condoms
Regulatory standards World Health Organization/United Nations Population 1025 Annex 11 2020  
Fund specifications for plain lubricants
Regulatory standards World Health Organization/United Nations Population 1033 Annex 6 2021  
Fund guidance on testing of male latex condoms
Regulatory standards World Health Organization/United Nations Population 1033 Annex 5 2021  
Fund recommendations for condom storage and shipping
temperatures
Regulatory standards Collaborative procedure
Regulatory standards/ Collaborative procedure between the World Health 996 Annex 8 2016  
prequalification Organization (WHO) Prequalification Team and national
regulatory authorities in the assessment and accelerated
national registration of WHO-prequalified pharmaceutical
products and vaccines
Regulatory standards Collaborative procedure in the assessment and accelerated 1010 Annex 11 2018  
national registration of pharmaceutical products and
vaccines approved by stringent regulatory authorities
Regulatory standards Good practices of national regulatory authorities in 1019 Annex 6 2019  
implementing the collaborative registration procedures
for medical products
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Category Guideline TRS Annex Year Available
languages
Regulatory standards Others
Regulatory standards WHO general guidance on variations to multisource 996 Annex 10 2016  
pharmaceutical products
Regulatory standards Good review practices: guidelines for national and 992 Annex 9 2015  
regional regulatory authorities
Regulatory standards Guidelines on submission of documentation for a 986 Annex 6 2014  
multisource (generic) finished product: quality part
Regulatory standards/ WHO guidelines for drafting a site master file 961 Annex 14 2011  
inspection
Regulatory standards Guidelines for the preparation of a contract research 957 Annex 7 2010  
organization master file
Regulatory standards Guidelines on active pharmaceutical ingredient master 948 Annex 4 2008  
file procedure
Regulatory standards International nonproprietary names for biological and 948 Annex 5 2008  
biotechnological substances: a review
Regulatory standards Guidelines for registration of fixed-dose combination 929 Annex 5 2005 EN
medicinal products
Regulatory standards Corrected Chinese version 929 Annex 5 2005 CH
固定剂量复方制剂注册指导原
Guidelines for registration of fixed-dose combination
medicinal products
 Category Guideline TRS Annex Year Available
languages
Regulatory standards Others (continued)
Regulatory standards/ Guidelines on packaging for pharmaceutical products 902 Annex 9 2002  
production
Regulatory standards WHO guideline on the implementation of quality 1025 Annex 13 2020  
management systems for national regulatory authorities
Regulatory standards Good reliance practices in the regulation of medical 1033 Annex 10 2021  
products: high level principles and considerations
Regulatory standards Good regulatory practices in the regulation of medical 1033 Annex 11 2021  
products
Prequalification
Prequalification Procedure for prequalification of pharmaceutical products 961 Annex 10 2011  
Prequalification Guidelines on submission of documentation for a 961 Annex 15 2011
multisource (generic) finished product. General format:
preparation of product dossiers in common technical
document format
Prequalification Guidelines on submission of documentation for a 970 Annex 4 2012  
multisource (generic) finished pharmaceutical product
for the WHO Prequalification of Medicines Programme:
quality part
Prequalification Procedure for assessing the acceptability, in principle, 953 Annex 4 2009  
of active pharmaceutical ingredients for use in
pharmaceutical products
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Category Guideline TRS Annex Year Available
languages
Prequalification (continued)
Prequalification Guidelines on submission of documentation for 986 Annex 5 2014  
prequalification of finished pharmaceutical products
approved by stringent regulatory authorities
Prequalification WHO guidelines on variations to a prequalified product 981 Annex 3 2013  
Prequalification Guidelines on the requalification of prequalified dossiers 957 Annex 6 2010  
Prequalification Prequalification of quality control laboratories: procedure 1003 Annex 3 2017  
for assessing the acceptability, in principle, of quality
control laboratories for use by United Nations agencies
Prequalification World Health Organization/United Nations Population 1025 Annex 9 2020  
Fund Prequalification Programme guidance for
contraceptive devices: male latex condoms, female
condoms and intrauterine devices