WHO: TRS 1060 Excipients GMP Guideline published

In April 2025, the WHO published the new TRS 1060 guideline package on its website - see also an overview of the main topics of the associated Annexes 2 to 9 in the news "New WHO Guideline Package: TRS 1060 published". This includes, for example, "TRS 1060 - Annex 3: WHO good manufacturing practices for excipients used in pharmaceutical products", which addresses the requirements for excipients in the pharmaceutical industry. This guideline was already published in 2023 as part of the public consultation process and now contains the chapters and subchapters listed here in its final version. In addition to formal adjustments, the title of Chapter 17 has been slightly modified and two annexes have been added.

The initial document for the now final guideline was the annex "The WHO guideline Good Manufacturing Practices: supplementary guidelines for the manufacture of pharmaceutical excipients," which was published in 1999 as Annex 5 in the WHO Technical Report Series No. 885.

You can find the table of contents of the guideline here:

1. Introduction and scope
2. Glossary
3. Quality management
   3.1 Quality risk management
   3.2 Management review
4. Complaints
5. Recalls
6. Returns
7. Self-inspection, quality audits and supplier's audits and approvals
8. Personnel
9. Sanitation and hygiene
10. Documentation
   10.1 Standard operating procedures and records
   10.2 Specifications
   10.3 Batch documentation
   10.4 Labels
11. Premises
12. Equipment and utilities
13. Materials
14. Production
   14.1 Rework
   14.2 Reprocessing
15. Qualification and validation
16. Quality control
17. Life cycle and continuous improvement principles
18. Storage and distribution
   18.1 Storage
   18.2 Distribution
References
Appendix 1 Risk management in the production and control of excipients used in pharmaceutical products
Appendix 2 List of examples of high-risk excipients and contaminants

The guideline "TRS 1060 - Annex 3: WHO good manufacturing practices for excipients used in pharmaceutical products" can be reviewed on the website of the WHO.