batchrecord

A batch record, sometimes written as batch record or batch production record (BPR), is a contemporaneous, product-specific document that documents the complete production history of a single batch of a manufactured product. In pharmaceutical and related industries, a master batch record (MBR) provides the template from which batch production records are created, and the executed document for a given batch is the batch record.

A batch record typically includes batch identification (name, batch number, production date), materials and components with supplier lot numbers and quantities, equipment used (identifiers and calibration status), and all steps of the manufacturing process with critical parameters, times, temperatures, pressures, and environmental conditions. It also records in-process inspections and test results, any deviations or investigations, changes and approvals, packaging and labeling instructions, and final product disposition. The record may also link to finished-product testing results and release status.

Purpose and regulatory context: Batch records enable traceability and accountability, support quality assurance, and provide the information needed to release a batch or conduct recalls and investigations. They are required under current good manufacturing practices (GMP) and applicable regulations such as 21 CFR Part 211 in the United States and EU GMP guidelines. Data integrity principles, such as being attributable, legible, contemporaneous, original, and accurate (ALCOA), apply to batch records.

Digital batch records: Many facilities maintain electronic batch records within manufacturing execution systems, ERP, or specialized electronic batch record systems. Electronic records require validation, audit trails, access controls, and proper archiving to ensure compliance throughout the product life cycle.