What the inspector wrote
The marketing authorisation holder's product file for Product Z contained the contract manufacturer's Product Quality Reviews for the last three periods. None bore any evidence of review, assessment or approval by the MAH. The most recent review recorded 'no marketing authorisation variations submitted' whereas the MAH had submitted and been granted two variations affecting the finished product specification in the period; the MAH had not supplied this information to the manufacturer. The quality agreement stated only that 'the Contract Acceptor shall perform Product Quality Reviews in accordance with EU GMP' and did not define the parties' responsibilities in producing the review or the MAH's role in evaluating it.
Why it was cited
Paragraph 1.11 names the MAH, where different from the manufacturer, as responsible for evaluating the results of the review and requires a technical agreement defining each party's responsibilities in producing it. Chapter 7 makes the contract giver ultimately responsible for outsourced activities and requires it to review and assess the acceptor's records and results.
The inaccurate variations section is the direct consequence: the manufacturer cannot report data it does not hold, and the MAH had not arranged to supply it. The review was therefore inaccurate, and 1.11 makes accuracy an MAH and QP responsibility.
What would have prevented it
- Write the PQR clause of the quality agreement to state who authors, who supplies each of the twelve items, the dates, and the MAH's documented evaluation.
- Implement an MAH evaluation form: read, agreed or disagreed with conclusions, adequacy of actions, MAH-held data not included, MAH actions arising, signature and date; route it to the certifying QP and into the MAH's management review.
- Send the MAH's data pack (complaints received directly, variations, commitments) to the manufacturer before the review cut-off, with a due date in the agreement.