EMA has published a Questions and Answers document (EMA/129980/2025) on how third party audit(s) should be reflected in part C of the QP Declaration with two new questions (Questions 3 and 9 under EU GMP guide part II: Basic requirements for active substances used as starting materials: GMP compliance for active substances).
- Is an audit performed by a third party acceptable?
- What are the expectations for the content of written final assessment of third-party audit reports?
The answers summarise quite clearly what is currently required and what a Qualified Person must be aware of, when accepting audit reports from external auditors, including the requirement of the written final assessment document and approval of third-party audit reports.
These Q&A’s were drafted and adopted by the GMDP Inspectors Working Group.
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