CMC & Manufacturing

Batch Record(BR)

A comprehensive document containing all information and instructions for manufacturing a specific batch of drug product.

Usage Examples

The batch record documented a 15-minute process deviation.
QA reviewed the executed batch record before release.
Electronic batch records improved data integrity.

What is BR?

A Batch Record (also Master Batch Record when blank, Executed Batch Record when completed) documents all materials, equipment, and procedures used in manufacturing a specific batch. It provides a complete history enabling traceability and investigation if needed.

Batch records include: formulation, equipment identification, processing parameters, in-process controls, yields, deviations, sampling points, and signatures of personnel performing and verifying each step. Electronic batch records (EBR) are increasingly common.

21 CFR 211.188 requires batch production records to document each significant step. Records must be reviewed and approved before batch release.

Regulatory Context

This term appears most often in cmc & manufacturing workflows where submission quality, regulatory evidence, and audit readiness depend on consistent language. It is commonly referenced alongside 21 CFR 211 188, EU GMP ANNEX 11.

FDAICHHealth Canada

When This Matters

The batch record documented a 15-minute process deviation.
QA reviewed the executed batch record before release.
Electronic batch records improved data integrity.

Common Mistakes

Failing to align CMC change narratives with current CFR/ICH expectations.
Submitting incomplete control strategy documentation.
Separating manufacturing and regulatory review cycles too late in execution.

Related Regulations

21 CFR 211 188EU GMP ANNEX 11

Frequently Asked Questions

The Master Batch Record is the approved blank template. The Executed Batch Record is the completed document for a specific batch with all actual data, times, signatures, and any deviations recorded.

FDA requires retention for at least 1 year after batch expiration or 3 years after distribution, whichever is longer. Many companies retain longer for litigation protection.