Sub-Part J - Records & Reports

9.1 - Records and Reports - Production Records

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To assure uniformity from batch to batch, master production and control records for each drug product and batch size, shall be prepared, dated, and signed; often referred to as the MMR. A completed batch production and control record shall be prepared for each batch of drug product produced from an accurate reproduction of the MMR.

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Batch production record being completed on a blue clipboard with yellow pen