EMA: New Q&A on Third Party Audits in the QP Declaration
EMA has published a Q&A on how to reflect third party audit(s) in part C of the QP declaration.
In part C of the QP declaration, information on audits as basis of QP Declaration of GMP Compliance should be given. Audit(s) of the active substance manufactured at the site(s) listed in PART A should be reported.
The Q&A includes a table where the manufacturing/import authorisation holder (MIAH) site (contract giver) and the audit body (contract acceptor) must be listed.
If the audit is undertaken by the MIAH, the auditing body column should be left empty. If the audit is performed by a third-party body (i.e. contract acceptor on behalf of the MIAH contract giver), this should be detailed as reflected in the contract.
In case the audit is performed on behalf of the MIAH by different entity/entities belonging to the same overall company, this should also be detailed in the auditing body column.
It is emphasised that in case the MIAH site does not perform the audit itself, the MIAH should be the contract giver. Consequently, the contract giver should always correspond to the MIAH site and the contract acceptor is expected to be the auditing body that actually performed the audit.
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