Batch recordBatch (production) record

A batch record (also called a batch manufacturing record, BMR, or batch production record, BPR) is the executed record for one specific batch: which materials, equipment, people and checks were used, what was measured, and what went wrong. It is copied from a master record that defines how the product should be made.

The regulatory detail on this page is US drug CGMP (21 CFR Part 211). Food, supplement, device and EU medicines rules use similar ideas with different required content, so treat this as one jurisdiction's model, not a universal list.

Section 211.188 requires complete information on the production and control of each batch, including:

1. an accurate, checked, dated and signed reproduction of the master record;
2. dates;
3. identity of individual major equipment and lines used;
4. specific identification of each batch of component or in-process material used;
5. weights and measures of components used;
6. in-process and laboratory control results;
7. inspection of the packaging and labeling area before and after use;
8. actual yield and percentage of theoretical yield at appropriate phases;
9. complete labeling control records, including specimens or copies of labeling used;
10. description of containers and closures;
11. any sampling performed;
12. identification of the people performing and directly supervising or checking each significant step (or, for steps done by automated equipment under 211.68, the person checking that step);
13. any investigation made under 211.192;
14. results of examinations made under 211.134.

All production and control records, including packaging and labeling, must be reviewed and approved by the quality control unit to determine compliance with established, approved written procedures before a batch is released or distributed.

Any unexplained discrepancy, including a yield outside the limits in the master record, or any failure to meet specifications must be thoroughly investigated whether or not the batch has been distributed, extended to other batches and products that may be associated, and written up with conclusions and follow-up.

V5 produces regulated reports including the BMR and MMR, records lot traceability during dispense and production, and supports 21 CFR Part 11 e-signatures and an audit trail. Batch disposition stays a human decision through the QA release queue; V5 does not release batches on its own, and whether your records meet 211.188 depends on your configuration, procedures and validation.