WHO Finalizes GMP Guidelines for Pharmaceutical Excipients in TRS 1060

In April 2025, the World Health Organization (WHO) published its new Technical Report Series (TRS) 1060 guideline package, including the finalized Annex 3: WHO Good Manufacturing Practices for Excipients Used in Pharmaceutical Products. Initially released for public consultation in 2023, the updated guideline builds on the 1999 document (Annex 5, TRS 885), and now includes several formal revisions and two new appendices.

The guideline outlines comprehensive GMP standards for excipients, covering quality management, documentation, sanitation, equipment, production practices, and more. Notable changes include a revised Chapter 17 title on life cycle and continuous improvement, and the addition of:

• Appendix 1: Risk management in excipient production and control
• Appendix 2: Examples of high-risk excipients and potential contaminants

This guidance supports improved safety and consistency in excipient manufacturing. The complete guideline and its table of contents are available on the WHO website under TRS 1060.

23-07-2025