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Question of the Week

What is a Batch Record Review?

The Batch Record Review (BRR) is an examination of the batch records that is independent of their creation and takes place at the end of the production process. It is usually conducted by the Quality Unit. The obligation to perform such a review is anchored both in the CFR and in the EU GMP Guide. The BRR is used to determine whether the batch records comply with both regulatory and the internal business requirements. The Batch Record Review is thus an important prerequisite for the batch certification and for the release of the finished drug product by the Qualified Person.

[GMP MANUAL, Chapter 19.F]

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