Batch Record

Master / Executed Batch Record (MBR / EBR)

The Master Batch Record (MBR), also called the master production and control record, is the QA-approved “recipe and method” for a product: the formula, the equipment, the process steps, the in-process controls, and the specifications. It is written and approved before manufacturing and is not changed without change control. In the US it is required by 21 CFR 211.186.

For every batch made, the MBR is issued as a Batch Production Record (BPR) — the executed batch record, or EBR when electronic — which the operators complete in real time as contemporaneous evidence of what actually happened: quantities, times, equipment IDs, signatures, and any deviations. Before the batch can be released, a qualified person independent of production reviews the executed record for completeness, correctness, and the disposition of every deviation (21 CFR 211.192). A blank field, a late entry, or an unexplained discrepancy is a classic data-integrity and GMP finding.

• —MBR / Master Production and Control Record — the approved instruction, one per product/strength (21 CFR 211.186).
• —BPR / Executed (or Electronic) Batch Record — the completed record for a specific batch (21 CFR 211.188).
• —Contemporaneous completion — entries made at the time of the activity, attributable and legible (ALCOA+).
• —Independent batch-record review and reconciliation before release (21 CFR 211.192).

US: 21 CFR 211.186 (master production & control records), 211.188 (batch production & control records), 211.192 (production record review); EU GMP Chapter 4.