Batch Record: who needs to review?

Recommendation

7/8 May 2024

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The Qualified Person (QP) often reviews the batch documentation personally prior to certification of the batch. But is the QP obliged to do so? No, it is not a requirement. Chapter 4 of the EU-GMP Guide states that "all records should be available to the Qualified Person" (4.27). It doesn't say that the QP must review them in any case. According 4.20i a batch processing record must be approved "by the person responsible for the processing operations". The head of the Production Department needs "to ensure that the production records are evaluated and signed by an authorised person before they are sent to the Quality Control Department" (Chapter 2.5iii). The head of the Quality Control Department then has the responsibility "to evaluate batch records" (2.6ii) as well. This means that before a batch record gets to the QP, it has been evaluated at least twice. The first review is done by production personnel, the second one by quality control or in some companies by a quality function who has the competence and is authorised to do so. However, a "system should be in place to indicate special observations and any changes to critical data" (4.27). So the QP should easily see if there have been any non-conformances or changes in the manufacturing process before releasing a batch. The QP should also be able to rely on the systems and know what is going on in production. A short review of batch related documentation by assistants to the QP based on a checklist could be an option for critical issues.

The U.S. Food and Drug Administration FDA sees the Quality Control Unit (QCU) as being responsible to "review records to assure that no errors have occurred" (CFR 211.22). The QCU also has the "responsibility for approving or rejecting all procedures or specifications." CFR 211.192 requires that all drug product production and control records are reviewed and approved by the QCU to determine compliance with written procedures before a batch is released or distributed.

For active pharmaceutical ingredients (APIs), ICH Q7 states that the "quality unit(s) should review and approve all appropriate quality-related documents" (2.21) including "reviewing completed batch production and laboratory control records of critical process steps before release of the API for distribution" (2.22(2)).

By the way, according to Chapter 4, batch documentation must be kept at least five years after certification of the batch by the Qualified Person (or for one year after expiry of the batch, whichever is longer).