Batch record: the document that decides whether the batch can be released

A batch record is the complete manufacturing history of one batch: what was used, what was done, by whom, when, with what equipment, and what the checks showed. It exists so that a qualified person can decide whether the batch may be released — and so that, years later, a regulator can reconstruct exactly how that batch was made.

Two documents share the name and should not be confused. The master batch record is the approved template: the instructions, specifications and limits for making the product. The executed batch record is the completed copy for one specific batch, filled in during manufacture. Only the second one is evidence of anything.

What a batch record has to capture

• Product, batch number, batch size and the master record version used.
• Materials issued: identity, quantity, lot numbers, and the release status of each.
• Equipment used, with identification and cleaning or line-clearance status.
• Each processing step with actual parameters recorded — not the target, the actual.
• In-process checks and their results, against defined limits.
• Yields at defined stages, with reconciliation and an explanation of any deviation from expected.
• Signatures: who performed each step and who verified the critical ones.
• Deviations raised, and their reference numbers.
• Packaging and labelling records, including reconciliation of printed materials.

The yield reconciliation is a step people underestimate. It is the arithmetic check that what came out is consistent with what went in, and an unexplained discrepancy is one of the few findings that cannot be argued away — the material went somewhere.

Contemporaneous, or it is not a record

Entries must be made when the activity happens. Writing up a shift from memory at the end of it, or transcribing from a scrap of paper, breaks the record even where every number turns out to be right — because the record now attests to something other than what happened.

The same principle governs corrections: strike through with a single line, initial and date, and state the reason. Never obliterate, never write over, never use correction fluid. The old value has to remain readable, because the correction is itself part of the history.

Blank spaces are findings. Every field either has a value, or an explicit N/A with an initial. A batch record with unfilled boxes cannot be distinguished from one where the step was skipped, and the reviewer is obliged to treat it as the second. Where a deviation reveals a systemic cause, it feeds the corrective action process rather than ending with the batch.

Review and release

1. Production reviews the record for completeness as the batch closes, not weeks later.
2. Quality reviews it against the master record, checking limits, signatures, deviations and reconciliation.
3. Every deviation is closed, or its impact on this batch is assessed and documented.
4. The qualified person or authorised releaser makes the release decision on the record as a whole.
5. The record is retained for the required period with everything referenced in it retrievable.

Because a batch record is worthless unless its attachments, deviations and corrections stay with it, it belongs in a system that keeps them together rather than in a folder of scans. Ettex Records holds the executed record with its linked deviations, its review trail and its version of the master, so the release decision and the evidence behind it are one object. What Ettex does not do is decide release — that judgement stays with the qualified person, and no document system substitutes for it.