Batch release and stability

A completed production run still needs a quality decision about its batch. Each batch release review connects that decision to lots and a quality reviewer in the person record, with certificate number, expiry date and status visible on the review. The Batch Release Reviews screen presents a queue, status distribution, certificate and expiry evidence, and the selected record’s review history. The team can examine the recorded batch context before deciding which evidence needs attention. Industry Reviewer bases the release decision on the recorded quality evidence.

• Review ownership. The reviewer record carries the reviewer identity through its user reference. Agree who may be selected as quality reviewer and how that person receives the Industry Reviewer responsibility. A displayed name must resolve to the correct account before any decision route is enabled.
• Decision progress. Pending and Testing identify work still under review; Approved and Rejected retain the outcome. Move the review from Pending through Testing to Approved after the relevant evidence is checked. Agree how the quality owner records an adverse decision and rehearse that route.
• Stability evidence. Each stability study links the batch to storage condition, pull date, result and disposition. Pending, Accept and Investigate distinguish a pull awaiting evaluation from an accepted result or an investigation. The pull date describes the evidence event and should survive a later correction.

Agree which certificate evidence is sufficient for your review and how certificate number is checked against certificates where applicable. Match the certificate number to the supporting certificate and selected lot during review. Resolve a changed number or inconsistent expiry with the quality owner before release. Decide how storage conditions are described consistently and who follows an Investigate disposition. External laboratory results and controlled documents need agreed import and access rules.

Take a batch whose production output has been accepted but whose review is still Testing. Industry Reviewer checks the linked lot record, the attributed quality reviewer and the certificate evidence shown on the screen. An acceptable production quantity cannot substitute for the batch decision. If certificate evidence refers to another lot, retain the discrepancy for investigation and do not record an unsupported approval.

Next, record a stability pull for the same batch and correct the reported result after review. The correction rehearsal must retain the original evidence and attribution through the configured successor-evidence route. Replaying the original capture must fail as a duplicate. Specialty review must not create another stock movement or financial posting. Rehearse these actions with the actual reviewer account. Require the named quality decision and confirm that ordinary capture cannot approve the batch.

• Batch review queue — Follow Pending and Testing work with its batch, reviewer, certificate number and expiry.
• Pending batch release reviews — Review records awaiting the configured decision route.
• Stability pull schedule — Follow dated pulls and Investigate evidence alongside the recorded result.

Review batch and stability evidence and rehearse quality holds. Agree the account mapping through roles.