WHO Draft Working Document on Good Practices for Quality Control Laboratories published for Comments

Recommendation

12-14 December 2023

Stability by Design - Live Online Training
- Stability Testing in Product Design and Method Development- Focus mainly on small-molecule APIs and drug products

End of August 2023, the World Health Organization (WHO) has published a draft working document entitled "WHO good practices for pharmaceutical quality control laboratories (QAS/21.882)".

The WHO invites all experts who may be interested in the subject to review the document, which was posted on the WHO Medicines website under "Working documents in public consultation". The WHO asks that comments should be submitted through the online platform PleaseReview™ by 06 October 2023. It is mentioned that only comments received by this deadline will be considered. Further information on the commenting process can be found on the first page of the new document.

The PDF file is quite extensive, with a total of 83 pages.

Document History

Already in 1999, the WHO Expert Committee on Specifications for Pharmaceutical Products (ECSPP) adopted the WHO good practices for national pharmaceutical control laboratories guidelines. These were published as Annex 3 of the WHO Technical Report Series, No. 902, 2002.

These guidelines were subsequently revised, renamed as "WHO good practices for pharmaceutical quality control laboratories" and finally published as Annex 1 of the WHO Technical Report Series, No 957, 2010.

The draft now published states: "Since the last revision of the guidelines, the experience from inspections of pharmaceutical quality control laboratories has enabled WHO to identify sections requiring clarification and the necessity to add new sections. Also, the COVID-19 pandemic has made clear that risk management, crisis management and business continuity are subjects which should be addressed to ensure that laboratories are prepared to face similar situations."

The purpose of the document is described as follows: "The present document provides advice on the quality management system (QMS) within which the analysis of pharmaceutical products by quality control laboratories (QCL) should be performed to ensure that accurate and reliable results are obtained. Compliance with the commendations provided in these guidelines will help promote international harmonization of good laboratory practices for pharmaceutical quality control laboratories and facilitate mutual recognition of test results."

Main Chapters of the new Document

The document is divided into the following main chapters:

• 1 General considerations
• 2 Glossary
• 3 Organization and management system
• 4 Planning and strategic management
• 5 Resources
• 6 Technical activities
• 7 Safety rules
• Appendix 1: Equipment for a first-stage and medium-sized pharmaceutical quality control laboratory
• Appendix 2: Recommendations for the target uncertainty and the maximum admissible uncertainty for normal analytical practice
• Appendix 3: Examples of the uncertainty estimation on compliance with normal analytical practice (the "worst case") for assay of pharmaceutical substances by chromatography

Updates

Compared to the version published as Annex 1 of the WHO Technical Report Series, No 957, 2010, some of the contents have been renumbered . The new draft also contains a number of extensions.

For example, the definition of the following terms have been added:

• acceptance criterion for an analytical result
• crisis management
• data integrity
• expanded uncertainty
• level of confidence
• risk
• target uncertainty

These topics are addressed accordingly in the newly added or enlarged subchapters, for example:

• 3.6 Control of data
• 4.4 Quality Risk management
• 4.5 Crisis management
• 6.7 Measurement uncertainty