This is a ready-to-use checklist for the intake gate that runs before the formal, timed batch record review begins. Its purpose is narrow and specific: catch a record that cannot be meaningfully reviewed in its current state and return it for correction before the review clock starts, rather than discovering the same defects partway through a substantive review. Replace every <<FILL: ...>> placeholder. A filled specimen follows.
How to use this checklist
- Complete this checklist first, before any substantive line-by-line review of the record’s content.
- Any single Fail means the record is not reviewable as submitted: stop, return it for correction, and log the return.
- This checklist does not replace the substantive review; passing it only means the record is ready to be reviewed, not that it is acceptable for disposition.
- The person completing this checklist may be the assigned QA reviewer or a dedicated intake function, depending on site procedure.
Section A: Record identity
Section B: Attribution and second checks
Section C: Corrections
Section D: Deviations and discrepancies referenced in the record
Section E: Required fields
Signoff
Acceptance criteria
A record is reviewable and may proceed to the substantive batch record review only when every item in Sections A through E is marked Pass. A single Fail returns the record for correction before the review clock starts; log the return with the batch record return-for-correction log so repeat sources of unreviewable records are visible in the trend.
The following shows a completed extract for an illustrative biologics fill-finish batch that failed the screen. The batch and numbers are illustrative.
Screening result: Returned for correction. Two failures: a missing second-check signature on a designated critical step (step 22, final container closure integrity check), and a deviation reference on step 31 with no corresponding deviation record on file. Both were routed back to manufacturing the same day; the record was resubmitted with the second signature obtained (with the verifier confirming the check itself was actually performed contemporaneously, not signed after the fact) and the deviation formally opened and referenced correctly. The record passed the screen on resubmission and proceeded to substantive review.
Common inspection findings this checklist prevents
- A batch record accepted into the review queue with a missing critical-step signature that only surfaces late in the review, or not at all.
- A deviation mentioned in passing in the record with no formal deviation record, discovered only if a reviewer happens to read the comment closely.
- Time spent on a substantive review of a record that ultimately has to be returned anyway, inflating cycle time and obscuring where the delay actually originated.
- No record of why a batch record was returned, so a site cannot see that the same line or product keeps failing the same screen.
How to adapt this checklist
- Add or remove items to match your record format (a fully electronic record may not need the paper-correction rows in Section C, but should keep an equivalent electronic-correction check).
- Decide who performs this screen at your site, a dedicated intake role or the assigned reviewer, and state it in the parent SOP.
- Set your own escalation rule for a record returned more than once for the same defect.
- Pair this checklist with the batch record review SOP so the screen and the substantive review are governed by one consistent procedure.
