Release decisions

A release decision records the judgment on a batch. Each decision has a code, review stage, decision, date, reviewer, rationale and possible conditions. The stage can identify QC Data Review, QA Review, Qualified Person Release or Final Batch Release. The decision can be Release, Reject, Release With Conditions, Hold or Reprocess. The batch reference makes the judgment traceable to one manufacturing lot; the product reference can add product context.

The batch release workflow posts every Approved batch to Released and records a matching operation receipt. A receipt identifies the operation, performed date, performer, outcome, detail, evidence link and source workflow. It gives the team evidence that the release operation was attempted or completed. A human decision and an operation outcome should both be inspected before the team treats a lot as released.

• Quality review. QA Manager checks the test, deviation, CAPA, change and calibration context for the lot.
• Independent decision. Qualified Person records the release judgment and rationale at the relevant review stage.
• Posting evidence. The release workflow changes an approved batch to Released and writes a receipt for the operation.

Settle who may record each review stage and how the organization handles a Hold, Reprocess or Release With Conditions decision. Decide which evidence link format the team will use on operation receipts. Check that the reviewer identity and rationale are recorded consistently. Record the independent release decision before setting the batch to Approved. That status triggers posting, so a Hold, Reprocess or Reject decision must leave the batch outside the Approved path.

Teams should agree how to reconcile a failed or pending receipt. The receipt’s outcome describes the operation; it is not a substitute for checking the batch status and human decision. QA Manager and Qualified Person should rehearse that comparison on a pilot lot.

A batch finishes testing with passing results and no unresolved deviation. QA Manager checks the product specification, test outcomes, calibration attention and any relevant change controls. Qualified Person records a Release decision at the Qualified Person Release stage with a decision date and rationale. QA Manager then marks the batch Approved. The workflow posts that status to Released and writes a Batch Released receipt. QA Manager checks the receipt outcome and link against the same batch.

Repeat the review with a batch whose decision is Hold. The decision record should preserve the reason, while the batch should remain out of the approved release path. This rehearsal exposes any gap between the human decision, batch state and actual posting behavior.

• Release decisions on hold — Decisions requiring a further action or a different disposition.
• Approved batches for release — Lots with the status that enters the posting path.
• Release operation receipts — Evidence and outcomes for performed release operations.

See release review for the decision and posting sequence and batch quality to release for the complete lot path.