Usage Examples
- The executed batch record showed a 15-minute hold-time excursion, so QA opened an investigation before release.
- We cannot ship until the quality control unit approves the batch record; actual yield fell outside the range stated in the master.
- Their EBR produces a batch record, but the audit trail is not reviewable, which fails the first Annex 11 question of the audit.
What is Batch Record (BR)?
A batch record is the controlled document that both instructs and evidences the manufacture of a single batch of drug product, capturing actual materials, equipment, parameters, yields, deviations, and operator signatures step by step.
The batch record exists because a released drug batch cannot be re-inspected into compliance after it ships. A batch record is the only contemporaneous evidence that the approved process was followed on that day, with those materials, on that equipment. Without it a manufacturer cannot prove the batch was made correctly, and an investigator arriving two years later has nothing to reconstruct.
A batch record covers one batch end to end: an accurate reproduction of the master production and control record, plus the actual dates, equipment used, component lot identities, weights and measures, in-process and laboratory results, yields, sampling, deviations and signatures. The batch record is not the master record it reproduces, not the analytical raw data behind a test result, and not the distribution record that tracks the batch after release.
A batch record is issued in practice from a controlled master, executed step by step as the operation happens, then routed to the quality control unit, which must review and approve it before the batch is released or distributed. Batch records increasingly live in electronic systems, which must still be able to show whether any batch-release data has changed since original entry.
Not to be confused with
- Master Production and Control Record
- the master is the approved blank template, prepared and signed by one person and independently checked and signed by a second. The batch record is the executed reproduction of that master carrying real data for one batch. One is the instruction; the other is the evidence.
- Certificate of Analysis
- a CoA is the outward-facing summary of test results that travels with the shipment. The batch record is the full internal manufacturing history that stays with the manufacturer and supports the CoA.
- Distribution record
- 21 CFR 211.180(a) treats production, control, and distribution records as separate categories. The batch record ends at release; the distribution record answers where the batch went afterwards, which is what drives a recall.
- Deviation report
- a deviation report documents one departure from the approved process. The batch record must reference the investigation, but filing a deviation does not substitute for the record entry that captured the excursion in the first place.
The obligations below are the anchors a batch record is inspected against.
What you must do
- 1Prepare, date and sign the master production and control record with a full handwritten signature by one person, and have a second person independently check, date and sign it21 CFR 211.186
- 2Reproduce that master accurately into each batch record, and have the reproduction checked for accuracy, dated and signed21 CFR 211.188
- 3Document each significant manufacturing step as performed: dates, major equipment and lines, component lot identities, weights and measures, in-process and laboratory control results, actual and percentage yield, sampling, and the identity of the person performing and the person checking21 CFR 211.188
- 4Have the quality control unit review and approve the record for compliance with approved written procedures before the batch is released or distributed, and investigate any unexplained discrepancy or specification failure21 CFR 211.192
- 5Retain the record for at least 1 year after the batch expiration date, or 3 years after distribution for exempt OTC products, and keep it readily available for authorized inspection at the establishment where the work occurred21 CFR 211.180(a), (c)
- 6Where the record is held electronically, be able to print out batch-release data showing whether it has changed since original entry, and restrict batch certification to Qualified PersonsEU GMP Annex 11, clauses 8.2 and 15
Common mistakes
Back-filling entries after the operation
211.188 requires the record to document each significant step, and a value written from memory hours later is not that documentation. Once an investigator can show entries were recorded retrospectively, the reliability of every batch produced under that practice is open to challenge, not just the one on the desk.
Treating quality control review as a signature sweep
211.192 requires review against approved written procedures and a thorough investigation of any unexplained discrepancy or specification failure. Approving a record that carries an unresolved yield excursion converts a process problem into a records violation, and the investigation then has to extend to other batches and products.
Assuming an electronic batch record is compliant because it is electronic
Annex 11 expects records supporting batch release to yield printouts showing whether data changed since original entry, and expects only Qualified Persons to certify release. An EBR whose audit trail cannot be reviewed and rendered intelligible offers less traceability than the paper form it replaced.
When This Matters
- The executed batch record showed a 15-minute hold-time excursion, so QA opened an investigation before release.
- We cannot ship until the quality control unit approves the batch record; actual yield fell outside the range stated in the master.
- Their EBR produces a batch record, but the audit trail is not reviewable, which fails the first Annex 11 question of the audit.
Frequently Asked Questions
The master batch record is the approved blank template; the executed batch record is the filled-in copy for one specific batch. 21 CFR 211.186 requires the master to be prepared, dated and signed by one person and independently checked by a second. 21 CFR 211.188(a) requires each batch record to be an accurate reproduction of it.
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