Complete guide to WHO Technical Report Series (TRS) and annexes, covering pharmaceutical standards, GMP, regulatory guidance, and quality control updates.
Table of Contents
Introduction
The WHO Technical Report Series (TRS) is a globally recognized collection of expert guidance documents, annexes, and recommendations issued by the World Health Organization (WHO) Expert Committee on Specifications for Pharmaceutical Preparations.
Each TRS volume includes multiple Annexes, which cover specific technical topics such as good manufacturing practices (GMP) for APIs, excipients, sterile products, and herbal medicines; biowaiver lists; stability testing; data integrity; nitrosamine control; collaborative registration procedures; and quality control standards.
Each annex provides detailed, evidence-based recommendations that help national regulatory authorities (NRAs), pharmaceutical manufacturers, quality control laboratories, and procurementagencies to ensure the safety, quality, and efficacy of medicines and medical products worldwide.
The TRS documents are continuously updated to align with ICH guidelines, modern GMP principles, WHO Model List of Essential Medicines, and the global regulatory landscape.
List of WHO Technical Report Series (TRS) and Annexes
Below is a complete list of all WHO Technical Report Series (TRS) volumes and their annexes, detailing updates, guidelines, and technical recommendations on pharmaceutical quality, safety, and regulatory practices.
Technical Report Series, No. TRS 1060 – Annex 9
Technical Report Series, No. TRS 1060 – Annex 8
Technical Report Series, No. TRS 1060 – Annex 7
Technical Report Series, No. TRS 1060 – Annex 6
TRS 1060 – Annex 6: Guideline on bioanalytical method validation and study sample analysis
Technical Report Series, No. TRS 1060 – Annex 5
Technical Report Series, No. TRS 1060 – Annex 4
TRS 1060 – Annex 4: Good practices for blood establishments
WHO Technical Report Series, No. TRS 1060 – Annex 3
TRS 1060 – Annex 3: WHO good manufacturing practices for excipients used in pharmaceutical products
Technical Report Series, No. TRS 1060 – Annex 2
List of international Comparator Products
WHO List of International Comparator Products
Technical Report Series, No. TRS 1052 – Annex 8
Technical Report Series, No. TRS 1052 – Annex 7
TRS 1052 – Annex 7: WHO guideline on Biopharmaceutics ClassificationSystem-based biowaivers
Technical Report Series, No. TRS 1052 – Annex 6
Technical Report Series, No. TRS 1052 – Annex 5
TRS 1052 – Annex 5: WHO/UNFPA female condom generic specification
WHO Technical Report Series, No. TRS 1052 – Annex 4
TRS 1052 – Annex 4: WHO good practices for pharmaceutical quality control laboratories
WHO Technical Report Series, No. TRS 1052 – Annex 3
WHO Technical Report Series, No. TRS 1052 – Annex 2
TRS 1052 – Annex 2: WHO good manufacturing practices for excipients used in pharmaceutical products
WHO Technical Report Series, No. TRS 1044 – Annex 10
TRS 1044 – Annex 10: WHO/UNFPA technical specification for TCu380A intrauterine device
WHO Technical Report Series, No. TRS 1044 – Annex 9
TRS 1044 – Annex 9: WHO/UNFPA guidance on natural rubber latex male condom stability studies
WHO Technical Report Series, No. TRS 1044 – Annex 8
Technical Report Series, No. TRS 1044 – Annex 7
TRS 1044 – Annex 7: WHO good manufacturing practices for investigational products
Technical Report Series, No. TRS 1044 – Annex 6
WHO Technical Report Series, No. TRS 1044 – Annex 5
TRS 1044 – Annex 5: WHO good manufacturing practices for medicinal gases
Technical Report Series, No. TRS 1044 – Annex 4
Updated: 30 April 2022
TRS 1044 – Annex 4: WHO guidelines on technology transfer in pharmaceutical manufacturing
WHO Technical Report Series, No. TRS 1044 – Annex 3
TRS 1044 – Annex 3: IAEA/WHO guideline on good manufacturing practices for investigational
WHO Technical Report Series, No. TRS 1044 – Annex 2
TRS 1044 – Annex 2: WHO good manufacturing practices for sterile pharmaceutical products
WHO Technical Report Series, No. TRS 1043 – Annex 4
Updated: 22 April 2022
Replacement of Annex 3 of WHO Technical Report Series, No. 822
WHO Technical Report Series, No. TRS 1043 – Annex 3
Updated: 22 April 2022
TRS 1043 – Annex 3: Guidelines on evaluation of biosimilars
Replacement of Annex 2 of WHO Technical Report Series, No. 977
WHO Technical Report Series, No. TRS 1043 – Annex 2
Updated: 11 May 2022
WHO Technical Report Series, No. TRS 1033 – Annex 11
TRS 1033 – Annex 11: Good regulatory practices in the regulation of medical products
WHO Technical Report Series, No. TRS 1033 – Annex 10
WHO Technical Report Series, No. TRS 1033 – Annex 9
WHO Technical Report Series, No. TRS 1033 – Annex 8
Updated: October 2021
WHO Technical Report Series, No. TRS 1033 – Annex 7
WHO Technical Report Series, No. TRS 1033 – Annex 6
WHO Technical Report Series, No. TRS 1033 – Annex 5
WHO Technical Report Series, No. TRS 1033 – Annex 4
TRS 1033 – Annex 4: WHO Guideline on data integrity
WHO Technical Report Series, No. TRS 1033 – Annex 3
TRS 1033 – Annex 3: Good manufacturing practices: water for pharmaceutical use
WHO Technical Report Series, No. TRS 1033 – Annex 2
WHO Technical Report Series, No. TRS 1025 – Annex 13
WHO Technical Report Series, No. TRS 1025 – Annex 12
Updated: April 2020
WHO Technical Report Series, No. TRS 1025 – Annex 11
TRS 1025 – Annex 11: UNFPA-WHO specifications for plain lubricants
WHO Technical Report Series, No. TRS 1025 – Annex 10
TRS 1025 – Annex 10: UNFPA-WHO technical specifications for male latex condoms
WHO Technical Report Series, No. TRS 1025 – Annex 9
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WHO Technical Report Series, No. TRS 1025 – Annex 8
Updated: April 2020
WHO Technical Report Series, No. TRS 1025 – Annex 7
Updated: 17 June 2020
TRS 1025 – Annex 7: Good storage and distribution practices for medical products
WHO Technical Report Series, No. TRS 1025 – Annex 6
WHO Technical Report Series, No. TRS 1025 – Annex 5
TRS 1025 – Annex 5: Quality management system requirements for national inspectorates
WHO Technical Report Series, No. TRS 1025 – Annex 4
TRS 1025 – Annex 4: WHO good chromatography practices
WHO Technical Report Series, No. TRS 1025 – Annex 3
TRS 1025 – Annex 3: Production of water for injection by means other than distillation
WHO Technical Report Series, No. TRS 1025 – Annex 2
TRS 1025 – Annex 2: IAEA – WHO good manufacturing practices for radiopharmaceutical products
WHO Technical Report Series, No. TRS 1025 – Annex 1
WHO Technical Report Series, No. TRS 1019 – Annex 6
WHO Technical Report Series, No. TRS 1019 – Annex 5
TRS 1019 – Annex 5: Guidelines on import procedures for medical products
WHO Technical Report Series, No. TRS 1019 – Annex 4
WHO Technical Report Series, No. TRS 1019 – Annex 3
TRS 1019 – Annex 3: Good manufacturing practices: guidelines on validation
WHO Technical Report Series, No. TRS 1019 – Annex 2
WHO Technical Report Series, No. TRS 1010 – Annex 11
WHO Technical Report Series, No. TRS 1010 – Annex 10
WHO Technical Report Series, No. TRS 1010 – Annex 9
WHO Technical Report Series, No. TRS 1010 – Annex 8
WHO Technical Report Series, No. TRS 1010 – Annex 7
TRS 1010 – Annex 7: WHO good pharmacopoeial practices: Chapter on herbal medicines
WHO Technical Report Series, No. TRS 1010 – Annex 6
TRS 1010 – Annex 6: WHO good pharmacopoeial practices: Chapter on compounding
WHO Technical Report Series, No. TRS 1010 – Annex 5
TRS 1010 – Annex 5: WHO guidance on testing of “suspect” falsified medicines
WHO Technical Report Series, No. TRS 1010 – Annex 4
TRS 1010 – Annex 4: WHO model certificate of analysis
WHO Technical Report Series, No. TRS 1010 – Annex 3
TRS 1010 – Annex 3: WHO considerations for requesting analysis of medicines samples
WHO Technical Report Series, No. TRS 1010 – Annex 2
TRS 1010 – Annex 2: WHO good manufacturing practices for the manufacture of herbal medicines
WHO Technical Report Series, No. TRS 1010 – Annex 1
TRS 1010 – Annex 1: WHO good manufacturing practices for the manufacture of herbal medicines
WHO Technical Report Series, No. TRS 1003 – Annex 5
Updated: 10 October 2017
TRS 1003, Annex 5: General background notes on the list of international comparator pharmaceutical products
WHO Technical Report Series, No. TRS 1003 – Annex 4
WHO Technical Report Series, No. TRS 1003 – Annex 3
WHO Technical Report Series, No. TRS 1003 – Annex 2
TRS 1003 – Annex 2: The International Pharmacopoeia: Revised concepts and future perspectives
WHO Technical Report Series, No. TRS 1003 – Annex 1
WHO Technical Report Series, No. TRS 999 – Annex 5
Updated: 18 June 2016
WHO Technical Report Series, No. TRS 999 – Annex 4
Updated: 25 May 2016
Technical Report Series, No. TRS 999 – Annex 3
Updated: 14 January 2016
TRS 999 – Annex 3: Regulatory assessment of approved rDNA-derived biotherapeutics
Addendum to Annex 4 of WHO Technical Report Series, No. 987
Technical Report Series, No. TRS 999 – Annex 2
Updated: 19 August 2016
TRS 999 – Annex 2: WHO good manufacturing practices for biological products
Technical Report Series, No. TRS 996 – Annex 8
WHO Technical Report Series, No. TRS 996 – Annex 7
Updated: 2016
TRS 996 – Annex 7: Guidelines on the conduct of surveys of the quality of medicines
Technical Report Series, No. TRS 996 – Annex 6
TRS 996 – Annex 6: WHO good trade and distribution practices for pharmaceutical starting materials
Technical Report Series, No. TRS 996 – Annex 5
Updated: 2016
TRS 996 – Annex 5: Guidance on good data and record management practices
Technical Report Series, No. TRS 996 – Annex 4. Appendix 2
Technical Report Series, No. TRS 996 – Annex 4. Appendix 1
TRS 996 – Annex 4, Appendix 1: WHO guidance on good manufacturing practices: Model inspection report
Technical Report Series, No. TRS 996 – Annex 3
Technical Report Series, No. TRS 996 – Annex 1
TRS 996 – Annex 1: WHO good pharmacopoeial practices
WHO Technical Report Series, No. TRS 992 – Annex 9
WHO Technical Report Series, No. TRS 992 – Annex 8
Technical Report Series, No. TRS 992 – Annex 6
Technical Report Series, No. TRS 992 – Annex 5
Updated: September 2015
Technical Report Series, No. TRS 992 – Annex 4
TRS 992 – Annex 4: General guidance on hold-time studies
Technical Report Series, No. TRS 992 – Annex 2
WHO Technical Report Series, No. TRS 986 – Annex 6
WHO Technical Report Series, No. TRS 986 – Annex 5
Technical Report Series, No. TRS 986 – Annex 4
Technical Report Series, No. TRS 986 – Annex 3
TRS 986 – Annex 3: WHO model quality assurance system for procurement agencies
Technical Report Series, No. TRS 986 – Annex 2
TRS 986 – Annex 2: WHO good manufacturing practices for pharmaceutical products: Main principles
Technical Report Series, No. TRS 981 – Annex 3
Updated: 10 October 2013
TRS 981 – Annex 3: WHO guidelines on variations to a prequalified product
Technical Report Series, No. TRS 981 – Annex 2
TRS 981 – Annex 2: WHO guidelines on quality risk management
Technical Report Series, No. TRS 981 – Annex 1
TRS 981 – Annex 1: Release procedure for International Chemical Reference Substances
Technical Report Series, No. TRS 970 – Annex 4
Technical Report Series, No. TRS 966 – Annex 10
TRS 966 – Annex 10: WHO general guidance on variations to multisource pharmaceutical products
Technical Report Series, No. TRS 966 – Annex 9
TRS 966 – Annex 9: Guidance for organizations performing in vivo bioequivalence studies
WHO Technical Report Series, No. TRS 966 – Annex 8
Updated: 17 November 2016
WHO Technical Report Series, No. TRS 966 – Annex 7
TRS 966 – Annex 7: Guidelines on the conduct of surveys of the quality of medicines
WHO Technical Report Series, No. TRS 966 – Annex 2
Updated: 10 October 2016
WHO Technical Report Series, No. TRS 961 – Annex 14
TRS 961 – Annex 14: WHO guidelines for drafting a site master file
WHO Technical Report Series, No. TRS 961 – Annex 13
TRS 961 – Annex 13: WHO guidelines for preparing a laboratory information file
WHO Technical Report Series, No. TRS 961 – Annex 10
TRS 961 – Annex 10: Procedure for prequalification of pharmaceutical products
WHO Technical Report Series, No. TRS 961 – Annex 9
Updated: 2 August 2011
WHO Technical Report Series, No. TRS 961 – Annex 8
WHO Technical Report Series, No. TRS 961 – Annex 7
Updated: 10 October 2011
TRS 961 – Annex 7: WHO guidelines on transfer of technology in pharmaceutical manufacturing
WHO Technical Report Series, No. TRS 961 – Annex 6
Updated: 10 October 2011
TRS 961 – Annex 6: WHO good manufacturing practices for sterile pharmaceutical products
WHO Technical Report Series, No. TRS 961 – Annex 4
WHO Technical Report Series, No. TRS 961 – Annex 2
TRS 961 – Annex 2: WHO good practices for pharmaceutical microbiology laboratories
WHO Technical Report Series, No. TRS 957 – Annex 7
WHO Technical Report Series, No. TRS 957 – Annex 6
TRS 957 – Annex 6: Guidelines on the requalification of prequalified dossiers
WHO Technical Report Series, No. TRS 957 – Annex 3
WHO Technical Report Series, No. TRS 957 – Annex 2
WHO Technical Report Series, No. TRS 953 – Annex 4
WHO Technical Report Series, No. TRS 953 – Annex 2. Appendix-1
WHO Technical Report Series, No. TRS 948 – Annex 5
WHO Technical Report Series, No. TRS 948 – Annex 4
TRS 948 – Annex 4: Guidelines on active pharmaceutical ingredient master file procedure
WHO Technical Report Series, No. TRS 943 – Annex 3
WHO Technical Report Series, No. TRS 943 – Annex 1
WHO Technical Report Series, No. TRS 929 – Annex 5
TRS 929 – Annex 5: Guidelines for registration of fixed-dose combination medicinal products
Technical Report Series, No. TRS 929 – Annex 4
TRS 929 – Annex 4: WHO guidelines for sampling of pharmaceutical products and related materials
Technical Report Series, No. TRS 917 – Annex 3
Technical Report Series, No. TRS 908 – Annex 1
Technical Report Series, No. TRS 902 – Annex 9
TRS 902 – Annex 9: Guidelines on packaging for pharmaceutical products
Technical Report Series, No. TRS 902 – Annex 7
TRS 902 – Annex 7: WHO guidelines on pre-approval inspections
WHO Technical Report Series
Basic tests for drugs: pharmaceutical substances, medicinal plant materials and dosage forms – 1998
Technical Report Series
Quality control methods for medicinal plant materials
WHO Technical Report Series, No. TRS 823 – Annex 2
TRS 823 – Annex 2: Inspection of pharmaceutical manufacturers
WHO QAS/15.630
Guidelines on the conduct of surveys of the quality of medicines – QAS/15.630
Table of WHO Technical Report Series – Complete List (TRS 823 – 1060)
| TRS No. | Annexes Included | Total Annexes |
| TRS 1060 (Apr 15, 2025) | Annex 2, 3, 4, 5, 6, 7, 8, 9 | 8 |
| TRS 1052 (Apr 26, 2024) | Annex 2, 3, 4, 5, 6, 7, 8 | 7 |
| TRS 1044 (2022) | Annex 2, 3, 4, 5, 6, 7, 8, 9, 10 | 9 |
| TRS 1043 (2022) | Annex 2, 3, 4 | 3 |
| TRS 1033 (2021) | Annex 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 | 10 |
| TRS 1025 (2020–2021) | Annex 1–13 (13 in total) | 13 |
| TRS 1019 (2019) | Annex 2, 3, 4, 5, 6 | 5 |
| TRS 1010 (2018) | Annex 2–11 | 10 |
| TRS 1003 (2017) | Annex 1, 2, 3, 4, 5 | 5 |
| TRS 999 (2016) | Annex 2,3 | 2 |
| TRS 996 (2016) | Annex 1, 3, 4 (Appendix 1 & 2), 5, 6, 7, 8 | 9 |
| TRS 992 (2015) | Annex 2, 4, 5, 6, 8, 9 | 6 |
| TRS 986 (2014) | Annex 2, 3, 4, 5, 6 | 5 |
| TRS 981 (2013) | Annex 1, 2, 3 | 3 |
| TRS 970 (2012) | Annex 4 | 1 |
| TRS 966 (2012) | Annex 2,7,8,9 | 4 |
| TRS 961 (2011) | Annex 2, 4, 6, 7, 8, 9, 10, 13, 14 | 9 |
| TRS 957 (2010) | Annex 2, 3, 6, 7 | 4 |
| TRS 953 (2009) | Annex 2 (App. 1), 4 | 2 |
| TRS 948 (2008) | Annex 4, 5 | 2 |
| TRS 943 (2007) | Annex 1, 3 | 2 |
| TRS 929 (2005) | Annex 4, 5 | 2 |
| TRS 917 (2003) | Annex 3 | 1 |
| TRS 908 (2002) | Annex 1 | 1 |
| TRS 902 (2002) | Annex 7, 9 | 2 |
| TRS (1998) | “Basic tests for pharmaceutical dosage forms” and “Quality control methods for medicinal plant materials” | 2 |
| TRS 823 (1992) | Annex 2 | 1 |
| WHO QAS/15.630 | – | 1 |
| WHO TRS | WHO List of international Comparator Products | 1 |
| WHO TRS (1998) | Basic tests for drugs | 1 |
| WHO TRS (1998) | Quality control methods for medicinal plant materials | 1 |
| Total Count: | 131 | |
Conclusion
The WHO Technical Report Series is an indispensable reference for anyone involved in drug development, quality assurance, regulatory affairs, or manufacturing. By following these annexes, stakeholders can harmonize their practices with global quality standards, facilitate faster product registration, and protect public health.
As regulatory requirements evolve and new challenges emerge—such as nitrosamine contamination, complex biologics, and global supply chain risks—the WHO TRS continues to serve as a living framework to guide countries and industry toward consistent, science-based regulatory decisions.
Abdus Sobhan Salim is professional experienced pharmacist in pharmaceuticals, author and founder of pharmabossbd.com, the Bangladeshi pharmaceutical blogger since 2019.
