qas26.998_qas26.998---points-to-consider-on-integration-of-environmental-sustainability-strategies-and-metrics-into-pharmaceutical-manufacturing

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Working document QAS/26.998

June 2026

DRAFT WORKING DOCUMENT FOR COMMENTS:

Points to consider on integration of

environmental sustainability strategies and

metrics into pharmaceutical manufacturing

Please submit your comments through the online platform, PleaseReview™:

https://who.pleasereview.net/Main/Default.aspx?action=loaddocument&reviewid=388

For any technical questions, please contact Dr Luther Gwaza, Team Lead, Norms and Standards for Pharmaceuticals,

Product Standards, Specifications and Nomenclature (gwazal@who.int), with a copy to Ms Maryann Akpama

(akpamam@who.int, nsp@who.int).

Your comments should be submitted through the online PleaseReview™ platform by 5 Aug 2026. Please note that only

comments received by this deadline will be considered for the preparation of this document.

If you wish to receive all our draft guidelines, please send your full name, organization/affiliation, and email address to

nsp@who.int and your name will be added to our electronic mailing list and review platform.

This is a draft. The content of this document is not final, and the text may be subject to revisions before publication. The

document may not be reviewed, abstracted, quoted, reproduced, transmitted, distributed, translated or adapted, in part or in

whole, in any form or by any means without the permission of the World Health Organization

Please send any request for permission to: Norms and Standards for Pharmaceuticals, Product Standards, Specifications and

Nomenclature, Department of Medicines and Health Products Policies and Standards, World Health Organization, CH-1211

Geneva 27, Switzerland, email: nsp@who.int.

The designations employed and the presentation of the material in this draft do not imply the expression of any opinion

whatsoever on the part of the World Health Organization concerning the legal status of any country, territory, city or area or

of its authorities, or concerning the delimitation of its frontiers or boundaries. Dotted lines on maps represent approximate

border lines for which there may not yet be full agreement.

The mention of specific companies or of certain manufacturers’ products does not imply that they are endorsed or

recommended by the World Health Organization in preference to others of a similar nature that are not mentioned. Errors

and omissions excepted, the names of proprietary products are distinguished by initial capital letters.

All reasonable precautions have been taken by the World Health Organization to verify the information contained in this

draft. However, the printed material is being distributed without warranty of any kind, either expressed or implied. The

responsibility for the interpretation and use of the material lies with the reader. In no event shall the World Health

Organization be liable for damages arising from its use. This draft does not necessarily represent the decisions or the stated

policy of the World Health Organization.

Working document QAS/26.998

Page 2

SCHEDULE FOR DRAFT WORKING DOCUMENT QAS/26.998

POINTS TO CONSIDER ON INTEGRATION OF

ENVIRONMENTAL SUSTAINABILITY

STRATEGIES AND METRICS INTO

PHARMACEUTICAL MANUFACTURING

Description of activity Date

Preparation of a working document. Jan – Mar 2026

Review of the document by the working group. April– May 2026

Mailing of the working document to the Expert Advisory Panel on

the International Pharmacopoeia and Pharmaceutical Preparations

(EAP) inviting comments and posting of the working document on

the WHO website for public consultation.

Jun - Jul 2026

Consolidation of comments received and review of feedback.

Preparation of working document for discussion.

Aug 2026

Review of the document by the working group. Aug – Sep 2026

Preparation of a working document for discussion and possible

adoption by the Expert Committee on Specifications for

Pharmaceutical Preparations (ECSPP).

Sep 2026

Presentation to the fifty-ninth meeting of the ECSPP. 12 – 16 Oct 2026

Any other follow-up action as required. TBC

Working document QAS/26.998

Page 3

POINTS TO CONSIDER ON INTEGRATION OF

ENVIRONMENTAL SUSTAINABILITY

STRATEGIES AND METRICS INTO

PHARMACEUTICAL MANUFACTURING

For any further information or requests, please send an email to the Norms and

Standards for Pharmaceuticals (NSP) Team at WHO at email nsp@who.int.

Contents

1. Introduction ............................................................................................................. 5

2. Glossary ................................................................................................................... 8

3. Organization and management .............................................................................. 13

4. Sustainable research and development .................................................................. 15

5. Sustainable facilities, utilities and equipment management .................................. 17

6. Production and process control ............................................................................. 20

7. Quality control laboratories ................................................................................... 21

8. Cleaning and waste management .......................................................................... 23

9. Packaging and distribution .................................................................................... 25

10. Documentation and reporting ............................................................................ 27

11. Raw materials, excipients and solvents ............................................................. 28

12. Digital technologies .......................................................................................... 31

13. Use of environmental sustainability strategies and metrics .............................. 33

14. Training and organizational culture................................................................... 37

15. Considerations for regulators and manufacturers .............................................. 38

16. Illustrative Examples of Environmental Sustainability Metrics, Scope 1–3

Emissions Accounting and Life Cycle Assessment ........................................................ 41

References ...................................................................................................................... 60

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