Inspection Prep Checklist — Batch Release

"Who released this batch — and what is the record of that authorization decision?"

• The authorizing individual is identified by name and title — not just a signature or initials
• The date and time of authorization is documented and can be verified as occurring before release to distribution
• The authorizing individual's qualification to make the release determination is established in the record (role, training, SOP authority)
• The release decision is traceable to the specific batch number and lot being released — not a blanket approval

"What specific evidence did the authorizing individual review when making the release decision for this exception — and where is that documented?"

• A document exists — separate from the batch record signature — that captures what the reviewer actually reviewed in evaluating the exception
• The specific atypical or out-of-trend result is identified and the decision about that specific result is documented
• The historical process data or specification context that makes the result atypical is referenced in the record
• The regulatory standard governing the release decision is cited (not just the specification — the decision standard)
• Alternative conclusions considered (e.g., reject, investigate further) are documented along with the reason they were not selected

"What was the basis for concluding this batch met all release criteria — specifically, what did the authorizing individual evaluate to reach that conclusion?"

• The release rationale is documented as a decision — not as a checkbox or signature on a form that confirms review occurred
• All required testing is confirmed complete prior to the release authorization date — or, if pending, the basis for releasing before completion is documented
• Any open deviations or investigations related to the batch are referenced and their status (closed, ongoing) is documented in the release record
• The release authorization record can be produced in under five minutes — not reconstructed from multiple systems

"Does your written procedure require this type of authorization documentation — and is your practice consistent with the procedure?"

• Your batch release SOP explicitly requires a separate authorization record (not just a batch record review) for batches containing exceptions
• The SOP defines what the authorization record must contain — not just that one is required
• A sample of recent exception batches has been reviewed against this checklist — not just the batches most likely to be reviewed during inspection
• The QA team can explain, in two sentences, the difference between a batch record review signature and a batch release authorization record