One dossier, built from the records
Each batch gets one release dossier, created from a versioned checklist template that is itself approved with segregation of duties and an e-signature. The checklist is filtered by batch category and sterility, so a sterile injectable sees sterility, endotoxin and media-fill items and a tablet batch does not. Typical items include:
- Batch manufacturing record complete and signed
- Yield reconciled
- QC testing complete and within specification
- Certificate of Analysis approved
- Deviations, OOS investigations and CAPAs closed
- Material genealogy traced
- Packaging reconciliation complete
- Sterility, endotoxin and media fill satisfactory (sterile batches)
- QA final review
Review by exception — with rules the system enforces
Critical items cannot be marked not applicable. The “QC complete” and “deviations closed” items cannot be attested while linked QC, deviation, OOS or CAPA records are still open — the status is derived from system data, not typed in. An unsatisfactory critical item raises a release blocker, and sterile failures (BI/CI, filter integrity, CCIT, visual inspection, media fill) raise blockers automatically. QA’s attention goes to the exceptions instead of re-checking every page.
Overrides are documented exceptions
Where a blocker must be overridden, it becomes a documented risk-acceptance exception: requested, then approved independently with segregation of duties and an e-signature. Evidence exceptions approved under QA authority expire, and once expired the item is blocked again automatically. Even an administrator cannot bypass a critical evidence gap.
The decision
The reviewer cannot be the dossier creator, and completing the review freezes the checklist. The release decision is e-signed by QA, and the person who executed the batch cannot be the releaser. Release automatically moves the batch’s finished-goods lots from quarantine to released; reject, hold, lift hold and close are recorded the same way. A Certificate of Batch Release PDF is generated on release.
QP release: where an EU or UK Qualified Person certifies batches, certification remains the QP’s own responsibility. Swat iQua Suite gives the QP or QA head the assembled evidence and an e-signed release record — it does not replace QP certification.
