Batch Record
ProductionAlso known as: Batch production record, Manufacturing record, Master batch record
A complete documented history of the manufacturing of a specific product batch.
What It Means
A batch record documents every step of manufacturing a specific lot: ingredients used (with lot numbers), equipment, personnel, environmental conditions, in-process testing, deviations, and final disposition. 21 CFR Part 111 Subpart P requires batch records for all dietary supplement production. Master batch records define the process; individual batch records document each execution.
What It Is Not
A batch record is NOT a COA. The batch record documents HOW the product was made; the COA documents WHAT the finished product contains. Batch records are internal documents. Manufacturers are not required to share them with customers, though quality agreements may require access.
Evidence and References
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