QP Declaration: New Q&As published

As reported, the European Medicines Agency (EMA) has published updated GMP Q&As with two new questions are dealing with third party audits. The answers summarise very well what is currently required and 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

Now, 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.

Part C of the QP Declaration should contain information on audits in the context of active substance manufacturing. This concerns the manufacturing sites of active substances listed in Part A of the QP Declaration.
According to GMP Part I, 5.29, the MIA holder (MIAH) must ensure compliance with the GMP rules either himself or through a third party acting on his behalf. If the audit is performed by the MIAH itself, the 'Auditing body' column must be left blank.
If the audit is carried out by a third party, this must be clearly stated in a contract. It is emphasised that the MIAH should be the contract giver, consequently, the contract giver should always be the MIAH site. The contract acceptor is the one who actually carried out the audit.

These Q&As may have significant impact on the current approaches followed by QPs and their (global) organisations on audits and auditing under the responsibility of a MIAH.