EMA: QPs must provide a written final Assessment and Approval of Third-Party Audit Reports

The European Medicines Agency (EMA) has published updated GMP Q&A's on the Agency web site. Two new questions are dealing with third party audits.

• "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?"

(Please refer to Questions 3 and 9 under EU GMP guide part II: Basic requirements for active substances used as starting materials: GMP compliance for active substances.) These Q&A's were drafted and adopted by the GMDP Inspectors Working Group.

The answers summarise very well what is currently required. And they also summarise what a QP (Qualified Person) needs be aware of, when accepting audit reports from external auditors, including a written final assessment and approval of third-party audit reports:

"Manufacturers may contract with third parties to undertake relevant audits. If a third party is involved, the arrangements should be subject to chapter 7 of the GMP guideline. There should be evidence that the contract-giver has evaluated the contract-acceptor accordingly and the MIA holder should ensure that there are arrangements in place to assure that any conflicts of interests are declared.

The QP has the ultimate responsibility to ensure that audit reports are properly evaluated when the audit is performed by a third party. The written final assessment document should provide a comprehensible summary of this evaluation and should be readily available and shared with authorities, if requested.

The assessment should include all expected elements of the auditing process and audit report(s) identified before, during and after the audit. In particular, this includes verification of contractual arrangements, scope and appropriate duration of audit, adequate competence of auditors considering the scope of the audit, planned audit frequency, and CAPAs whether adequate and how these are to be followed up. Any conflicts of interest identified should be discussed.

QPs should ensure that the written final assessment and approval of third-party audit reports includes an evaluation of a declaration or absence of any conflicts of interest made by auditors and/or the contracting parties. Conflicts of interest may come to light after the QP has relied upon a third-party audit report and it may be necessary for the QP to undertake a retrospective assessment."