Batch Record Review and Release Procedure

Purpose. Describes how completed batch records at every site are reviewed, how deviations are assessed and how a batch is released, held or rejected.

1.Scope

This procedure applies to every food, beverage and pharmaceutical batch. At the food sites the batch record includes the production record, the critical control point monitoring records, the changeover record, the label check and the laboratory results. At the pharmaceutical site the batch manufacturing record, the packaging record, the in process and finished product test results and the environmental monitoring records are reviewed together.

2.Review by production

The line leader or the production supervisor must review the batch record at the end of the batch for completeness, legibility and correct entries, confirm that every step was signed and, where required, verified by a second person, and sign the production review. Any missing entry must be resolved with the operator on the same shift and recorded as a deviation if the record cannot be completed.

3.Review by quality

The quality assurance officer must review the batch record against the specification and the HACCP plan or the batch manufacturing record, confirm every critical control point and in process check was within limit or that any deviation has been investigated and closed with a documented decision, confirm the laboratory results meet specification and reconcile yield and packaging counts.

• Every critical control point within limit or deviation closed
• Laboratory results meet specification
• Yield and packaging reconciliation within limits
• Label and artwork check recorded
• Deviations investigated and dispositioned

4.Release decision

Only the quality manager, or at the pharmaceutical site the authorised person, will release a batch. The release will be recorded in the batch record system with the date and the name of the releasing person. A batch with an open deviation, a failed result or an unresolved reconciliation will remain on hold.

5.Hold and reject

A held batch will be labelled and stored in the quarantine area and its status set to On hold in the batch record system. A batch that cannot be released will be rejected, the disposition recorded and the customer notified where the contract requires it. Rejected product will be destroyed or reworked only under a documented decision.

6.Timeframes and records

Food batches will be reviewed and released within two working days of completion and pharmaceutical batches within the time set in the customer agreement. Batch records will be retained for the period in the records schedule and never altered after release.