Working document QAS/23.

931
August 2023

1
2
3 DRAFT DISCUSSION DOCUMENT FOR COMMENTS
4

5 WHO GOOD MANUFACTURING PRACTICES AND INSPECTION

6 GUIDELINES COMPENDIUM: GAP ANALYSIS FOR
7 REVISIONS/NEW TEXT
8
Please submit your comments through the specific word template for this document [Table for comments-qas23.931]
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For any technical questions, you may contact Dr Luther Gwaza, Team Lead, Norms and Standards for Pharmaceuticals,
Technical Standards and Specifications (gwazal@who.int), with a copy to Ms Bezawit Kibret (kibretb@who.int,
nsp@who.int).

Comments should be submitted through the online platform on or by 06 October 2023. Please note that only
comments received by this deadline will be considered for the preparation of this document.

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9
10
11 © World Health Organization 2023
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13 All rights reserved.
14
15 This is a draft. The content of this document is not final, and the text may be subject to revisions before
16 publication. The document may not be reviewed, abstracted, quoted, reproduced, transmitted, distributed,
17 translated or adapted, in part or in whole, in any form or by any means without the permission of the World
18 Health Organization
19
20 Please send any request for permission to: Ms Sinéad Jones, Norms and Standards for Pharmaceuticals, Technical
21 Standards and Specifications, Department of Health Products Policy and Standards, World Health Organization,
22 CH-1211 Geneva 27, Switzerland, email: jonessi@who.int.
23
24 The designations employed and the presentation of the material in this draft do not imply the expression of any
25 opinion whatsoever on the part of the World Health Organization concerning the legal status of any country,
26 territory, city or area or of its authorities, or concerning the delimitation of its frontiers or boundaries. Dotted
27 lines on maps represent approximate border lines for which there may not yet be full agreement.
28
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29 The mention of specific companies or of certain manufacturers' products does not imply that they are endorsed
30 or recommended by the World Health Organization in preference to others of a similar nature that are not
31 mentioned. Errors and omissions excepted, the names of proprietary products are distinguished by initial capital
32 letters.
33
34 All reasonable precautions have been taken by the World Health Organization to verify the information
35 contained in this draft.
36
37 However, the printed material is being distributed without warranty of any kind, either expressed or implied.
38 The responsibility for the interpretation and use of the material lies with the reader. In no event shall the World
39 Health Organization be liable for damages arising from its use. This draft does not necessarily represent the
40 decisions or the stated policy of the World Health Organization.
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41
42 DRAFT DISCUSSION DOCUMENT QAS/23.931:
43 WHO GOOD MANUFACTURING PRACTICES AND INSPECTION
44 GUIDELINES COMPENDIUM: GAP ANALYSIS FOR
45 REVISIONS/NEW TEXT
46
Description of activity Date
Gap analysis of the WHO GMP compendium by consultant May 2023
Discussion of the gap analysis at the Consultation on Good Practices 27 - 29 June 2023
for Health Products Manufacture and Inspection
Preparation of the draft discussion document August 2023
Mailing the working document to the Expert Advisory Panel on the 28 August - 6 October
International Pharmacopoeia and Pharmaceutical Preparations (EAP), 2023
inviting comments and posting the working document on the WHO
website for public consultation.
Presentation to the Fifty-seventh meeting of the ECSPP 9 – 13 October 2023
Any other follow-up action as required
47

48
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49 WHO GOOD MANUFACTURING PRACTICES AND INSPECTION

50 GUIDELINES COMPENDIUM: GAP ANALYSIS FOR
51 REVISIONS/NEW TEXT
52
53 Contents
54 1. Introduction
55 2. Scope
56 3. Shortlist of GMP or related guidelines/guidance for stakeholder feedback
57 4. Proposed new topics for stakeholder feedback
58
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59 1. Introduction
60 The World Health Organization (WHO) is committed to providing high-quality, evidence-based
61 guidelines for pharmaceuticals to ensure that medicines are of good quality, safe, and effective. The
62 completed and updated list of WHO norms and standards for medicines, quality assurance (QA) and
63 regulatory guidance texts adopted by the Expert Committee and published in the WHO Technical
64 Report Series (TRS) is published as Annex 1 in TRS 1044, 2022 (1). These guidelines are accessible as
65 annexes to various WHO Technical Reports available online. In addition, the annexes are gathered into
66 a compendium (Quality assurance of pharmaceuticals: a compendium of guidelines and related
67 materials) to make it easier for users to access and use the materials. In 2019, WHO published version
68 9 of the consolidated compendium. Version 10 will consist of two volumes: volume 1 on regulatory
69 guidance and related texts and volume 2 on Good Manufacturing Practices (GMP) and inspection. A
70 gap analysis was conducted to ensure that the GMP compendium is up to date and meets the needs
71 of WHO Member States and stakeholders.

72 2. Scope
73 GMP and inspection guidelines must be updated to reflect the constant technical progress in
74 pharmaceutical production, regulatory science, and quality control. WHO is soliciting stakeholder
75 feedback in line with WHO procedures for adequate consultation as described in the procedure for
76 developing WHO medicines QA guidelines (2). The discussion document aims to solicit feedback on
77 which WHO GMP guidelines, inspection guidelines or related guidelines for pharmaceuticals should
78 be reviewed or updated and new topics to develop guidelines or guidance to address gaps in the
79 existing WHO GMP compendium.
80
81 A short list below reflects guidelines identified through the gap analysis and informal consultation, or
82 over seven years old or for which significant changes in the field necessitate a review or update. The
83 feedback can cover any aspect, including the relevance of the guidelines to current needs, the
84 accuracy and up-to-dateness of the guidelines, the most important topics that the guidelines should
85 cover, the most important gaps in the existing guidelines, or if other current guidelines supersede the
86 guideline, therefore, should be withdrawn. Additional feedback for review or updates of guidelines
87 adopted by the Expert Committee not included in the shortlist but published in the TRS is welcomed.
88 Recommendations for developing new guidelines or guidance based on current needs are also
89 welcomed.
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91 3. Shortlist of GMP or related guidelines/guidance for stakeholder feedback

Title Annex/TRS No/year Change History Weblink

1. Provisional guidelines on inspection of pharmaceutical Annex 2, TRS, No.823, 1992 https://www.who.int/publications/

manufacturers m/item/trs823-annex2
2. Inspections of drug distribution channels Annex 6, TRS, No.885, 1999 https://www.who.int/publications-
detail-redirect/WHO_TRS_885
3. Guidelines on pre-approval inspections Annex 7, TRS, No.902, 2002 https://www.who.int/publications/
m/item/trs902-annex7
4. Guidelines on packaging for pharmaceutical products Annex 9, TRS, No.902, 2002 https://www.who.int/publications/
m/item/annex-9-trs-902
5. Model certificate of good manufacturing practices Annex 5, TRS, No.908, 2003 Link to the guideline
6. WHO guidelines for sampling of pharmaceutical products Annex 4, TRS, No.929, 2005 https://www.who.int/publications/
and related materials m/item/annex-4-trs-929
7. WHO guidelines for the preparation of a contract research Annex 7, TRS, No.957, 2010 https://www.who.int/publications/
organization master file m/item/trs-957-annex-7
8. WHO good manufacturing practices for pharmaceutical Annex 3, TRS, No.957, 2010 https://www.who.int/publications/
products containing hazardous substances m/item/trs957-annex3
9. WHO good manufacturing practices for active Annex 2, TRS, No.957, 2010 Supersedes https://www.who.int/publications/
pharmaceutical ingredients Part three, m/item/annex-2-trs-957
Section 18 of
Annex , TRS
823, 1992

10. WHO good practices for pharmaceutical microbiology Annex 2, TRS, No.961, 2011 https://www.who.int/publications/
laboratories m/item/trs961-annex2
11. WHO guidelines for drafting a site master file Annex 14, TRS, No.961, 2011 https://www.who.int/publications/
m/item/trs961-annex14
12. WHO guidelines for preparing a laboratory information file Annex 13, TRS, No.961, 2011 https://www.who.int/publications/
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Title Annex/TRS No/year Change History Weblink

m/item/trs961-annex13
13. WHO guidelines on quality risk management Annex 2, TRS, No. 981, 2013 https://www.who.int/publications/
m/item/trs981-annex2
14. WHO model quality assurance system for procurement Annex 4, TRS, No.986, 2014 https://www.who.int/publications/
agencies: aide-memoire for inspection m/item/annex4-trs986-eng
15. WHO good manufacturing practices for pharmaceutical Annex 2, TRS, No.986, 2014 Supersedes https://www.who.int/publications/
products: main principles Annex 3, TRS m/item/trs986-annex2
961, 2011
16. WHO general guidance on hold-time studies Annex 4, TRS, No.992, 2015 https://www.who.int/publications/
m/item/trs992-annex4
17. Guidance on good manufacturing practices: inspection Annex 4, TRS, No. 996, 2016 Supersedes https://cdn.who.int/media/docs/d
report. Annex 6, TRS efault-source/2021-dha-
908, 2003 docs/trs996_annex4.pdf?sfvrsn=c4
4d141a_1&download=true
18. WHO good practices for desk assessment of compliance Annex 9, TRS, No.1010, 2018 https://www.who.int/publications/
with good manufacturing practices, good laboratory m/item/trs1010-annex9
practices and good clinical practices for medical products
regulatory decisions
19. Guidelines on heating, ventilation and air-conditioning Annex 8, TRS, No.1010, 2018 Supersedes https://www.who.int/publications/
systems for non-sterile pharmaceutical products Annex 5, TRS m/item/Annex-8-trs-1010
961, 2011
20. WHO good manufacturing practices for heating, ventilation Annex 2, TRS, No.1019, 2019 Link to the guideline
and air-conditioning systems for non-sterile pharmaceutical
products (part 2): interpretation of guidelines
21. WHO good manufacturing practices: guidelines on Annex 3, TRS, No.1019, 2019 https://www.who.int/publications/
validation m/item/trs1019-annex3
22. WHO good chromatography practices Annex 4, TRS, No.1025, https://www.who.int/publications/
2020 m/item/trs1025-annex4

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94 3. Proposed new topics for stakeholder feedback

Title Comments/Notes

1. Advanced manufacturing technologies: Guideline on continuous

manufacturing
2. Reflection paper/points to consider on artificial intelligence in pharmaceutical A guideline at this stage is premature, and a Points to Consider
manufacturing / reflection paper is appropriate.
3. Guidelines for cannabis Growers and manufacturers
4. Computerized systems
5. GMP main principles for veterinary products (potential collaboration with
World Organisation for Animal Health (WOAH))
6. Advanced manufacturing technologies: other topical areas

95
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96 References
97
98 1. WHO Expert Committee on Specifications for Pharmaceutical Preparations. Annex 1:
99 Guidelines and guidance texts adopted by the Expert Committee on Specifications for
100 Pharmaceutical Preparations. In: WHO Expert Committee on Specifications for
101 Pharmaceutical Preparations: fifty-sixth report. Geneva: World Health Organization; 2022:69
102 - 86 (WHO Technical Report Series, No., 1044;
103 https://apps.who.int/iris/rest/bitstreams/1486295/retrieve, accessed 25 August 2023).
104 2. WHO Expert Committee on Specifications for Pharmaceutical Preparations. Annex 1:
105 Procedure for the development of World Health Organization medicines quality assurance
106 guidelines. In: WHO Expert Committee on Specifications for Pharmaceutical Preparations:
107 fifty-third report. Geneva: World Health Organization; 2019:87 - 91 (WHO Technical Report
108 Series, No., 1019; https://apps.who.int/iris/rest/bitstreams/1217390/retrieve, accessed 25
109 August 2023).
110
111