Batch release, or batch disposition, is the decision to release a batch for sale or supply — or to reject it. It follows a review of all the evidence: the executed batch record, yields and reconciliations, in-process and finished product test results, the certificate of analysis, deviations and investigations, environmental monitoring and, for sterile products, sterilisation and media fill status. In the EU and UK, a Qualified Person certifies the batch; elsewhere the decision rests with the quality unit.
Why it matters in GMP
Release is the last line of defence before a product reaches patients. 21 CFR 211.22 gives the quality control unit the authority to approve or reject drug products, and 21 CFR 211.192 requires production and control records to be reviewed before a batch is released. Inspectors look for releases made while investigations were still open, missing evidence, and releases signed by people involved in making the batch.
- Use a defined checklist that adapts to the product type, such as sterile or non-sterile.
- Block release automatically while critical evidence is missing or failing.
- Document any risk-based exception, approved by someone independent.
- Move released stock out of quarantine only through the release decision.
How Swat iQua Suite handles it
Swat iQua Suite builds one release dossier per batch from a versioned checklist — BMR complete and signed, yield reconciled, QC complete and in specification, CoA approved, deviations, OOS and CAPA closed, genealogy traced, packaging reconciled and sterile results satisfactory where relevant. Critical items cannot be marked not applicable, and items linked to open records cannot be attested. The release decision is e-signed, and the batch executor can never be the QA releaser. Release moves finished-goods lots from quarantine to released and produces a Certificate of Batch Release PDF.