Guidance to review a Batch Record

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The Qualified Person (QP) often reviews the batch documentation personally prior to certification of a batch. But is the QP obliged to do so? No, because this is not a requirement.

Chapter 2 of the EU-GMP Guide (Personnel) states that a QP “must ensure that each batch has been manufactured and checked in compliance with the laws and in accordance with the requirements of the marketing authorization.” (2.6)

Chapter 4 of the EU-GMP Guide (Documentation) adds 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 to 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 authorized person” (2.7iii). So, the first review has to be done by production personnel, a second one might be done by a quality function that has the competence and is authorized to do so. A short review by assistants to the QP based on a checklist could be an option.

Annex 16 to the EU-GMP Guidelines states that the QP is responsible for ensuring that “all records are complete and endorsed by appropriate personnel” (1.7.11). 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 certifying a batch. The QP should also be able to rely on the systems and know what is going on in production and quality control.

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.

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).


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