WHO Guidelines: Norms and Standards for Pharmaceuticals

1. Guidelines: Production
2. Guidelines: Quality control
3. Guidelines: Prequalification
4. Guidelines: Regulatory standards
5. Guidelines: Development
6. Guidelines: Distribution
7. Guidelines: Inspections
8. Guidelines: Quality Assurance

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Area of Application Guidelines
No.

26 April 2024
TRS 1052 - Annex 3: IAEA/WHO good manufacturing practices for in house cold kits for radiopharmaceutical
preparations

26 April 2024
TRS 1052 - Annex 2: WHO good manufacturing practices for excipients used in pharmaceutical products

14 November 2022
Guidelines:
1 TRS 1044 - Annex 5: WHO good manufacturing practices for medicinal gases
Production
31 October 2022
TRS 1044 - Annex 2: WHO good manufacturing practices for sterile pharmaceutical products

30 September 2022
TRS 1044 - Annex 6: WHO good practices for research and development facilities of pharmaceutical products

31 August 2022
TRS 1044 - Annex 7: WHO good manufacturing practices for investigational products

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Area of Application Guidelines
No.

31 July 2022
TRS 1044 - Annex 3: IAEA/WHO guideline on good manufacturing practices for investigational

30 April 2022
TRS 1044 - Annex 4: WHO guidelines on technology transfer in pharmaceutical manufacturing

17 November 2021
TRS 1033 - Annex 3: Good manufacturing practices: water for pharmaceutical use

10 October 2021
TRS 1033 - Annex 4: WHO Guideline on data integrity

10 October 2021
TRS 1033 - Annex 2: Points to consider when including Health-Based Exposure Limits (HBELs) in cleaning
validation

30 September 2020
TRS 1025 - Annex 2: IAEA - WHO good manufacturing practices for radiopharmaceutical products

20 April 2020
TRS 1025 - Annex 6: Points to consider for manufacturers and inspectors: environmental aspects of manufacturing
for the prevention of antimicrobial resistance

20 April 2020
TRS 1025 - Annex 3: Production of water for injection by means other than distillation

30 September 2019
TRS 1019 - Annex 2: WHO good manufacturing practices for heating, ventilation and air-conditioning systems for
non-sterile pharmaceutical products (part 2): interpretation of guidelines

25 January 2019
TRS 1019 - Annex 3: Good manufacturing practices: guidelines on validation

10 October 2018

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Area of Application Guidelines
No.
TRS 1010 - Annex 8: Guidelines on heating, ventilation and air-conditioning systems for non-sterile
pharmaceutical products

30 September 2018
TRS 1010 - Annex 1: WHO good manufacturing practices for the manufacture of herbal medicines

30 September 2018
TRS 1010 - Annex 2: WHO good manufacturing practices for the manufacture of herbal medicines

14 April 2016
TRS 996 - Annex 3: WHO good manufacturing practices for biological products (jointly with the Expert Committee
on Biological Standardization)

31 October 2015
TRS 992 - Annex 4: General guidance on hold-time studies

1 October 2014
TRS 986 - Annex 2: WHO good manufacturing practices for pharmaceutical products: Main principles

25 January 2013
TRS 981 - Annex 2: WHO guidelines on quality risk management

30 September 2011
TRS 961 - Annex 4: WHO good manufacturing practices for blood establishments (jointly with the Expert
Committee on Biological Standardization)

1 October 2010
TRS 957 - Annex 2: WHO good manufacturing practices for active pharmaceutical ingredients (bulk drug
substances)

30 September 2010
TRS 957 - Annex 3: WHO good manufacturing practices for pharmaceutical products containing hazardous
substances

30 September 2010

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Area of Application Guidelines
No.
TRS 957 - Annex 7: WHO guidelines for the preparation of a contract research organization master file

10 October 2002
TRS 902 - Annex 9: Guidelines on packaging for pharmaceutical products

Frequently asked questions: WHO good manufacturing practices in pharmaceutical practice

26 April 2024
TRS 1052 - Annex 5: WHO/UNFPA female condom generic specification

26 April 2024
TRS 1052 - Annex 4: WHO good practices for pharmaceutical quality control laboratories

30 September 2022
TRS 1044 - Annex 9: WHO/UNFPA guidance on natural rubber latex male condom stability studies

30 June 2022
TRS 1044 - Annex 10: WHO/UNFPA technical specification for TCu380A intrauterine device

Guidelines: Quality 10 October 2021

2
control TRS 1033 - Annex 6: World Health Organization/United Nations Population Fund Guidance on testing of male latex
condoms

20 May 2021
TRS 1025 - Annex 4: WHO good chromatography practices

1 October 2020
TRS 1025 - Annex 1: The International Pharmacopoeia: Procedure for the development of monographs and other
texts

30 September 2020
TRS 1025 - Annex 11: UNFPA-WHO specifications for plain lubricants

30 September 2020

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Area of Application Guidelines
No.
TRS 1025 - Annex 10: UNFPA-WHO technical specifications for male latex condoms

1 October 2018
TRS 1010 - Annex 6: WHO good pharmacopoeial practices: Chapter on compounding

30 September 2018
TRS 1010 - Annex 5: WHO guidance on testing of “suspect” falsified medicines

30 September 2018
TRS 1010 - Annex 3: WHO considerations for requesting analysis of medicines samples

30 September 2018
TRS 1010 - Annex 4: WHO model certificate of analysis

30 September 2018
TRS 1010 - Annex 7: WHO good pharmacopoeial practices: Chapter on herbal medicines

30 September 2017
TRS 1003 - Annex 1: WHO guidelines for selecting marker substances of herbal origin for quality control of herbal
medicines

30 September 2017
TRS 1003 - Annex 2: The International Pharmacopoeia: Revised concepts and future perspectives

30 September 2016
TRS 996 - Annex 1: WHO good pharmacopoeial practices

30 September 2015
TRS 992 - Annex 2: The International Pharmacopoeia: Updating mechanism for the section on
radiopharmaceuticals

30 September 2015
TRS 992 - Annex 6: WHO recommendations for quality requirements when plant-derived artemisinin is used as a
starting material in the production of antimalarial active pharmaceutical ingredients

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Area of Application Guidelines
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1 October 2013
TRS 981 - Annex 1: Release procedure for International Chemical Reference Substances

30 September 2011
TRS 961 - Annex 2: WHO good practices for pharmaceutical microbiology laboratories

30 September 2011
TRS 961 - Annex 13: WHO guidelines for preparing a laboratory information file

30 September 2007
TRS 943 - Annex 3: WHO general guidelines for the establishment, maintenance and distribution of chemical
reference substances

30 September 2007
TRS 943 - Annex 1: The International Pharmacopoeia: Related substances tests - dosage form monographs
guidance notes

1 October 2002
TRS 908 - Annex 1: WHO recommendations on risk of transmitting animal spongiform encephalopathy agents via
medicinal products

12 August 1998
Basic tests for drugs: pharmaceutical substances, medicinal plant materials and dosage forms - 1998

1 May 1998
Quality control methods for medicinal plant materials

WHO International Chemical Reference Substances (availability, price, ordering)

The International Pharmacopoeia

Guidelines: 20 April 2020

3
Prequalification 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

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Area of Application Guidelines
No.

10 October 2017
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

17 November 2016
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...

9 October 2014
TRS 986 - Annex 5: Guidelines on submission of documentation for prequalification of finished pharmaceutical
products approved by stringent regulatory authorities

10 October 2013
TRS 981 - Annex 3: WHO guidelines on variations to a prequalified product

10 October 2012
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

10 October 2011
TRS 961 - Annex 10: Procedure for prequalification of pharmaceutical products

10 October 2010
TRS 957 - Annex 6: Guidelines on the requalification of prequalified dossiers

10 October 2009
TRS 953 - Annex 4: Procedure for assessing the acceptability, in principle, of active pharmaceutical ingredients for
use in pharmaceutical products

Guidelines:
26 April 2024
4 Regulatory
TRS 1052 - Annex 8: Multisource (generic) pharmaceutical products: guidelines on registration requirements to
standards
establish interchangeability

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Area of Application Guidelines
No.

26 April 2024
TRS 1052 - Annex 7: WHO guideline on Biopharmaceutics ClassificationSystem-based biowaivers

26 April 2024
TRS 1052 - Annex 6: WHO Biowaiver List: proposal to waive in vivobioequivalence requirements for WHO Model
Listof Essential Medicines immediate-release, solid...

26 April 2024
TRS 1052 - Annex 5: WHO/UNFPA female condom generic specification

30 September 2022
TRS 1044 - Annex 6: WHO good practices for research and development facilities of pharmaceutical products

30 September 2022
TRS 1044 - Annex 9: WHO/UNFPA guidance on natural rubber latex male condom stability studies

30 June 2022
TRS 1044 - Annex 10: WHO/UNFPA technical specification for TCu380A intrauterine device

10 October 2021
TRS 1033 - Annex 9: Guidelines on the implementation of the WHO Certification Scheme on the quality of
pharmaceutical products moving in international commerce

10 October 2021
TRS 1033 - Annex 7: World Health Organization/United Nations Population Fund guidance on conducting post-
market surveillance of condoms

10 October 2021
TRS 1033 - Annex 6: World Health Organization/United Nations Population Fund Guidance on testing of male latex
condoms

10 October 2021
TRS 1033 - Annex 5: World Health Organization/United Nations Population Fund Recommendations for condom
storage and shipping temperatures

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Area of Application Guidelines
No.

9 October 2021
TRS 1033 - Annex 11: Good regulatory practices in the regulation of medical products

9 October 2021
TRS 1033 - Annex 10: Good reliance practices in the regulation of medical products: high level principles and
considerations

9 March 2021
TRS 953 - Annex 2, Appendix 1: Stability testing of active pharmaceutical ingredients and finished pharmaceutical
products: Stability conditions for WHO Member States...

30 September 2020
TRS 1025 - Annex 10: UNFPA-WHO technical specifications for male latex condoms

30 September 2020
TRS 1025 - Annex 11: UNFPA-WHO specifications for plain lubricants

30 September 2020
TRS 1025 - Annex 2: IAEA - WHO good manufacturing practices for radiopharmaceutical products

20 April 2020
TRS 1025 - Annex 13: WHO guideline on the implementation of quality management systems for national
regulatory authorities

10 October 2019
TRS 1019 - Annex 5: Guidelines on import procedures for medical products

10 October 2019
TRS 1019 - Annex 6: Good practices of national regulatory authorities in implementing the collaborative
registration procedures for medical products

10 October 2019
TRS 1019 - Annex 4: Protocol to conduct equilibrium solubility experiments for the purpose of Biopharmaceutics
Classification System-based classification of active...

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Area of Application Guidelines
No.

10 October 2018
TRS 1010 - Annex 11: Collaborative procedure in the assessment and accelerated national registration of
pharmaceutical products and vaccines approved by...

30 September 2018
TRS 1010 - Annex 10: WHO guidelines on stability testing of active pharmaceutical ingredients and finished
pharmaceutical products

30 September 2018
TRS 1010 - Annex 9: WHO good practices for desk assessment of compliance with good manufacturing practices,
good laboratory practices and good clinical practices for...

10 October 2017
TRS 1003 - Annex 4: WHO Global Model Regulatory Framework for Medical Devices including in vitro diagnostic
medical devices

10 October 2017
TRS 1003, Annex 5: General background notes on the list of international comparator pharmaceutical products

10 October 2016
TRS 966 - Annex 9: Guidance for organizations performing in vivo bioequivalence studies

30 September 2016
TRS 966 - Annex 10: WHO general guidance on variations to multisource pharmaceutical products

10 October 2015
TRS 992, Annex 8 - Guidance on the selection of comparator pharmaceutical products for equivalence assessment
of interchangeable multisource (generic) products

10 October 2015
TRS 992 - Annex 9: Good review practices: guidelines for national and regional regulatory authorities

30 September 2015

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Area of Application Guidelines
No.
TRS 992 - Annex 6: WHO recommendations for quality requirements when plant-derived artemisinin is used as a
starting material in the production of...

10 October 2014
TRS 986 - Annex 6: Guidelines on submission of documentation for a multisource (generic) finished
pharmaceutical product: quality part

25 January 2013
TRS 981 - Annex 2: WHO guidelines on quality risk management

31 October 2011
TRS 961 - Annex 14: WHO guidelines for drafting a site master file

30 September 2010
TRS 957 - Annex 7: WHO guidelines for the preparation of a contract research organization master file

10 October 2008
TRS 948 - Annex 4: Guidelines on active pharmaceutical ingredient master file procedure

9 October 2008
TRS 948 - Annex 5: International Nonproprietary Names for biological and biotechnological substances: a review

10 October 2005
TRS 929 - Annex 4: WHO guidelines for sampling of pharmaceutical products and related materials

9 October 2005
TRS 929 - Annex 5: Guidelines for registration of fixed-dose combination medicinal products

10 October 2003
TRS 917 - Annex 3: WHO pharmaceutical starting materials certification scheme (SMACS): guidelines on
implementation

10 October 2002
TRS 902 - Annex 9: Guidelines on packaging for pharmaceutical products

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Area of Application Guidelines
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21 March 2024
List of International Comparator products

30 October 2012
TRS 970 - Annex 3: Pharmaceutical development of multisource (generic) finished pharmaceutical products:
Guidelines: points to consider
5
Development
31 December 2011
TRS 970 - Annex 5: Development of paediatric medicines: points to consider in formulation

20 April 2022
TRS 1044 - Annex 8: Points to consider for setting the remaining shelf-life of medical products upon delivery

10 October 2021
TRS 1033 - Annex 9: Guidelines on the implementation of the WHO Certification Scheme on the quality of
pharmaceutical products moving in international commerce

17 February 2021
TRS 986 - Appendix 6: Interagency finished pharmaceutical product questionnaire

Guidelines: 17 June 2020

6
Distribution TRS 1025 - Annex 7: Good storage and distribution practices for medical products

10 October 2019
TRS 1019 - Annex 5: Guidelines on import procedures for medical products

30 September 2018
TRS 1010 - Annex 5: WHO guidance on testing of “suspect” falsified medicines

10 October 2016
TRS 966 - Annex 7: Guidelines on the conduct of surveys of the quality of medicines

10 October 2016

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Area of Application Guidelines
No.
TRS 996 - Annex 6: WHO good trade and distribution practices for pharmaceutical starting materials

10 October 2016
TRS 966 - Annex 2: FIP–WHO technical guidelines: Points to consider in the provision by health-care professionals
of children-specific preparations that are not available as authorized products

10 October 2015
TRS 992 - Annex 5: Technical supplements to Model guidance for the storage and transport of time- and
temperature–sensitive pharmaceutical products

10 October 2014
TRS 986 - Annex 4: Assessment tool based on the model quality assurance system for procurement agencies: aide-
memoire for inspection

30 September 2014
TRS 986 - Annex 3: WHO model quality assurance system for procurement agencies

10 October 2011
TRS 961 - Annex 9, Supplement 4: Building security and fire protection

10 October 2011
TRS 961 - Annex 9, Supplement 13: Qualification of shipping containers

10 October 2011
TRS 961 - Annex 9, Supplement 2: Design and procurement of storage facilities

10 October 2011
TRS 961 - Annex 9, Supplement 7: Qualification of temperature-controlled storage areas

10 October 2011
TRS 961 - Annex 9, Supplement 8: Temperature mapping of storage areas

10 October 2011
TRS 961 - Annex 9: Introduction to the Technical Supplements

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Area of Application Guidelines
No.
10 October 2011
TRS 961 - Annex 9, Supplement 15: Temperature and humidity monitoring systems for transport operations

10 October 2011
TRS 961 - Annex 9, Supplement 9: Maintenance of refrigeration equipment

10 October 2011
TRS 961 - Annex 9, Supplement 5: Maintenance of storage facilities

10 October 2011
TRS 961 - Annex 9, Supplement 1: Selecting sites for storage facilities

10 October 2011
TRS 961 - Annex 9, Supplement 11: Qualification of refrigerated road vehicles

10 October 2011
TRS 961 - Annex 8: Joint FIP/WHO guidelines on good pharmacy practice: standards for quality of pharmacy
services

10 October 2011
TRS 961 - Annex 9, Supplement 3: Estimating the capacity of storage facilities

10 October 2011
TRS 961 - Annex 9, Supplement 14: Transport route profiling qualification

10 October 2011
TRS 961 - Annex 9, Supplement 10: Checking the accuracy of temperature control and monitoring devices

10 October 2011
TRS 961 - Annex 9, Supplement 16: Environmental management of refrigeration equipment

10 October 2011
TRS 961 - Annex 9, Supplement 6: Temperature and humidity monitoring systems for fixed storage areas

10 October 2011

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Area of Application Guidelines
No.
TRS 961 - Annex 9, Supplement 12: Temperature-controlled transport operations by road and by air

2 August 2011
TRS 961 - Annex 9: Model guidance for the storage and transport of time and temperature sensitive
pharmaceutical products

10 October 2005
TRS 929 - Annex 4: WHO guidelines for sampling of pharmaceutical products and related materials

10 October 2003
TRS 917 - Annex 3: WHO pharmaceutical starting materials certification scheme (SMACS): guidelines on
implementation

20 May 2021
TRS 1025 - Annex 4: WHO good chromatography practices

20 April 2020
TRS 1025 - Annex 6: Points to consider for manufacturers and inspectors: environmental aspects of manufacturing
for the prevention of antimicrobial resistance

20 April 2020
TRS 1025 - Annex 5: Quality management system requirements for national inspectorates
Guidelines:
7
Inspections 30 September 2018
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

30 September 2016
TRS 996 - Annex 4, Appendix 2: WHO good manufacturing practices inspection: Example of a risk category
assessment of the site depending on level of compliance and inspection frequency

30 September 2016
TRS 996 - Annex 4, Appendix 1: WHO guidance on good manufacturing practices: Model inspection report

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Area of Application Guidelines
No.
31 October 2015
TRS 992 - Annex 4: General guidance on hold-time studies

10 October 2014
TRS 986 - Annex 4: Assessment tool based on the model quality assurance system for procurement agencies: aide-
memoire for inspection

31 October 2011
TRS 961 - Annex 14: WHO guidelines for drafting a site master file

30 September 2011
TRS 961 - Annex 13: WHO guidelines for preparing a laboratory information file

30 September 2010
TRS 957 - Annex 7: WHO guidelines for the preparation of a contract research organization master file

30 September 2002
TRS 902 - Annex 7: WHO guidelines on pre-approval inspections

30 September 1992
TRS 823 - Annex 2: Inspection of pharmaceutical manufacturers

10 October 2021
TRS 1033 - Annex 4: WHO Guideline on data integrity

10 October 2021
TRS 1033 - Annex 2: Points to consider when including Health-Based Exposure Limits (HBELs) in cleaning
Guidelines: Quality
8 validation
Assurance
17 February 2021
TRS 986 - Appendix 6: Interagency finished pharmaceutical product questionnaire

25 January 2019
TRS 1019 - Annex 3: Good manufacturing practices: guidelines on validation

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Area of Application Guidelines
No.

10 October 2016
TRS 996 - Annex 6: WHO good trade and distribution practices for pharmaceutical starting materials

10 October 2016
TRS 966 - Annex 7: Guidelines on the conduct of surveys of the quality of medicines

30 June 2015
Guidelines on the conduct of surveys of the quality of medicines - QAS/15.630

10 October 2014
TRS 986 - Annex 4: Assessment tool based on the model quality assurance system for procurement agencies: aide-
memoire for inspection

30 September 2014
TRS 986 - Annex 3: WHO model quality assurance system for procurement agencies

Sachin Kumar Sharma

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