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
- regulation21 CFR 111.605-111.610 batch record requirements
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