The Batch Record: The Document That Answers Every Later Question

A batch record is the complete, contemporaneous account of how one batch was made: the materials and their lot numbers, the equipment, the process steps, the in-process values, the operators, the times and the release decision. It is written as the batch is made, not reconstructed afterwards.

1. The header

The header identifies the product, the batch number, the date, the quantity planned and the quantity produced. The batch number is the key that links the record to the samples, the stability pulls, the retained units and any complaint. A batch number that is not unique is not a batch number.

2. Materials and lots

Every material is recorded with its lot number and its weighed quantity. The lot numbers are what allow a recall to be narrow rather than total. A record that lists materials without lots cannot support a recall and cannot support a customer enquiry.

3. The process steps

Each step records the temperature, the time, the equipment and the operator. A step that says “mixed until uniform” without a time and a speed is a step that cannot be repeated. Repeatability is the whole point of a batch record.

4. In-process values

pH, viscosity, appearance and fill weight are recorded at the defined points, with the value and the action taken. A value outside the limit with no documented action is a finding in any audit.

5. Signatures

Each critical step is initialled by the operator and countersigned by a second person. A record signed by one person for every step is a record that nobody verified. The second signature is the control, not the ceremony.

6. Deviations

Any departure from the process is recorded as a deviation with its own reference, its investigation and its conclusion. An unrecorded deviation is invisible until the batch fails, and then it is not recoverable. Recording a deviation is not an admission; it is the evidence that the process is controlled.

7. The release decision

The record ends with the release or rejection decision, the tests that support it and the name of the person who made it. A batch that is released without a documented decision is a batch that is released by default.

8. Retention

Keep the record for the period required by the market, typically the shelf life plus one year and often longer. A digital record must be backed up, versioned and readable in ten years. A record stored on one laptop is not retained.

9. The audit value

An auditor reads the batch record to see whether the process is controlled, not whether the numbers are pretty. Gaps, corrections without initials and identical values across three batches are the three things an auditor notices first.

10. Templates

A template should be short enough to complete honestly and detailed enough to be useful. A twenty-page record is filled in retrospectively; a two-page record with the right fields is filled in as the batch runs. Design for honesty rather than for completeness.

11. Where it fits

Batch documentation runs across the capsule serum range; the in-process detail continues in the in-process entry.