Master production records are essentially written instructions for a specific manufacturing process, and the FDA requires a different master production record for each unique formulation and batch size. Master production software can help maintain master production records that meet FDA 21 CFR Part 211 requirements.
Batch production records are copies of the master production record. They are used to document information for each individual batch. According to the FDA, batch production records must be prepared for each batch of drug product.
Before a batch is released or distributed, all drug production and control records must be approved by quality control. This includes records for packaging, labeling and compliance. Unexplained discrepancies must be investigated.
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