Glossary · Batch and process operations
Batch record
Also known as: Batch production record, Electronic batch record (EBR)
German: Chargenprotokoll
In batch manufacturing, a batch record is the collection of information about the production of one batch, such as the recipe used, materials and quantities, process values, events, operator actions, deviations and approvals. ISA-88 Part 4 (IEC 61512-4) defines a reference model for batch production records.
- Batch control
- Process industry
In one sentence
A batch record collects the recipe, materials, process data, events, deviations and approvals for the production of one batch.
Example
The electronic batch record for a vaccine lot shows the weighed quantities, the temperature profile of the reactor and the electronic signature of the release.
How it applies
- Engineering: The batch system collects data per Unit (ISA-88) and procedural element and links it to the batch identifier, so that records can be generated automatically.
- Operation: Operators confirm manual steps and document deviations within the record, instead of on separate paper forms.
- Compliance: In pharmaceutical manufacturing, batch records are GMP records; electronic versions must meet data integrity requirements such as ALCOA+ and, for the US market, 21 CFR Part 11 (electronic records and signatures). A batch system alone does not make records compliant; validation and procedures are needed.
- Documentation: The documentation team describes how records are created, reviewed, corrected and released, and what the report fields mean. Terminology in the batch record, HMI and SOPs should match.
Batch record vs. event log
A general Event log captures system events regardless of product. A batch record is organized around one batch and serves as evidence of how that batch was made.