WHO Publishes 51st Technical Report Series on Pharmaceutical Preparations (TRS No. 1003)
The World Health Organization (WHO) Expert Committee on Specifications for Pharmaceutical Preparations has published its 51st report, Technical Report Series No. 1003. This 252-page report summarizes the outcomes of the Expert Committee meeting held in October 2016 in Geneva and includes all adopted and draft guidances as appendices.
Key highlights from TRS No. 1003:
- Chapter 7 – Quality Assurance & Good Manufacturing Practices (GMP): Focuses on updates to validation guidance.
- Appendix 1: Validation of HVAC systems will reference the revised WHO GMP guidelines for HVAC (June 2017). Detailed design examples will be published separately in a Q&A document.
- Appendix 2: Validation of water systems for pharmaceutical use now references WHO Guidelines on water for pharmaceutical use.
- Appendix 3: Cleaning validation retained and will be republished.
- Appendices 4–6: Revisions on analytical method validation, computerized systems validation, and qualification of systems/equipment are adopted; publication is pending.
- Appendix 7: Non-sterile process validation updated; previously published as Annex 3, TRS No. 992 (2015), and will be republished.
A complete guidance package on validation, including all appendices and cross-references, is expected by the end of the year.
Additionally, the Committee is developing a new guidance on good practices for desk review, aiming to optimize the use of available resources by relying on inspectional data from trusted sources instead of on-site inspections—a practice already used by PQT–Inspections and the Australian Therapeutic Goods Administration.
Source: WHO Technical Report Series No. 1003, July 2017
