WHO: Excipients GMP Guideline published for Comments

In March 2023, the WHO published the first draft of the guideline "WHO good manufacturing practices for excipients used in pharmaceutical products" on its website for comments. The public comment period ends on 26 May 2023, so that notes and comments can still be submitted until then. The proposals will then be reviewed and the resulting draft is expected to be discussed by a consultation group in July 2023.

The current draft is based on "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. This annex was the starting point for the guideline which can now be commented on.

The current proposal of the new guideline is divided into 18 chapters, partly with subchapters. The individual chapters are listed below:

                   1. Introduction and scope
                   2. Glossary
                   3. Quality management
                      - Quality Risk Management
                      - 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
                      - Standard operating procedures and records
                      - Specifications
                      - Batch documentation
                      - Labels
                 11. Premises
                 12. Equipment and utilities
                 13. Materials
                 14. Production
                     - Rework
                     - Reprocessing
                 15. Qualification and validation
                 16. Quality control
                 17. Product life cycle and continuous improvement
                 18. Storage and distribution
                      - Storage
                      - Distribution

You can view and comment on the draft guideline "WHO good manufacturing practices for excipients used in pharmaceutical products" on the WHO website.