This is a ready-to-use checklist for the review that precedes a batch disposition decision. It turns the acceptance criteria for a good disposition into line items so nothing is checked from memory. Mark each item Pass, Fail, or NA, record the evidence reference, and route any Fail per your deviation procedure before the disposition authority signs. Replace every <<FILL: ...>> placeholder. A filled specimen follows.
How to use this checklist
- Complete one checklist per batch, tied to the batch disposition record.
- Every item marked NA needs a one-line reason (for example, “no shared equipment, dedicated line”).
- Any Fail blocks release until resolved through the deviation or investigation process.
- The reviewer completing this checklist is not the disposition authority who signs the final decision, and neither is the person who manufactured the batch.
Header
| Field | Entry |
|---|---|
| Product / strength | <<FILL>> |
| Batch / lot number | <<FILL>> |
| Reviewer | <<FILL>> |
| Review date | <<FILL>> |
| Linked disposition record | <<FILL: disposition record ID>> |
Section A: Manufacturing and packaging records
| # | Item | Pass / Fail / NA | Evidence reference | Basis |
|---|---|---|---|---|
| A1 | Executed batch production record complete, every step in sequence, no unexplained gap | <<FILL>> | 21 CFR 211.192 | |
| A2 | All in-process control results present and within limits | <<FILL>> | 21 CFR 211.110 | |
| A3 | Line clearance recorded before and between operations | <<FILL>> | GMP | |
| A4 | Yield reconciled at each major step; any out-of-limit yield explained | <<FILL>> | 21 CFR 211.103 | |
| A5 | Executed packaging and labeling records complete; label reconciliation balanced | <<FILL>> | 21 CFR 211.125 | |
| A6 | Every signature and independent verification present and contemporaneous | <<FILL>> | Good documentation practices |
Section B: Materials
| # | Item | Pass / Fail / NA | Evidence reference | Basis |
|---|---|---|---|---|
| B1 | All components, active ingredient, and excipients released before use | <<FILL>> | 21 CFR 211.84 | |
| B2 | All materials within retest or expiry at time of use | <<FILL>> | 21 CFR 211.87 | |
| B3 | Primary packaging and printed components released and correct | <<FILL>> | 21 CFR 211.122 | |
| B4 | Certificates of analysis for incoming materials on file | <<FILL>> | GMP |
Section C: Testing and analytical
| # | Item | Pass / Fail / NA | Evidence reference | Basis |
|---|---|---|---|---|
| C1 | Every required release test performed on the correct sample | <<FILL>> | 21 CFR 211.165 | |
| C2 | All results pass against the current approved specification and method | <<FILL>> | 21 CFR 211.165 | |
| C3 | Every OOS investigated and closed; no testing into compliance | <<FILL>> | 21 CFR 211.192 | |
| C4 | Every OOT assessed and closed | <<FILL>> | Trend procedure | |
| C5 | Finished-batch certificate of analysis issued | <<FILL>> | GMP | |
| C6 | Stability samples placed if required by protocol | <<FILL>> | 21 CFR 211.166 |
Section D: Quality events
| # | Item | Pass / Fail / NA | Evidence reference | Basis |
|---|---|---|---|---|
| D1 | Full list of deviations linked to the batch obtained | <<FILL>> | Deviation procedure | |
| D2 | Each deviation closed, or open with a signed batch-impact assessment | <<FILL>> | 21 CFR 211.192, Annex 16 | |
| D3 | Each batch-impact assessment concludes acceptability on evidence, not assertion | <<FILL>> | 21 CFR 211.192 | |
| D4 | Change controls in effect during manufacture identified and approved | <<FILL>> | Change control procedure | |
| D5 | Any CAPA triggered is tracked; no CAPA closure required before release | <<FILL>> | CAPA procedure |
Section E: Environment and equipment
| # | Item | Pass / Fail / NA | Evidence reference | Basis |
|---|---|---|---|---|
| E1 | Equipment used was qualified and within calibration during the batch | <<FILL>> | 21 CFR 211.68, 211.160 | |
| E2 | Cleaning records and cleaning validation status current for shared equipment | <<FILL>> | 21 CFR 211.67 | |
| E3 | Environmental monitoring data for the relevant windows reviewed (sterile product) | <<FILL>> | Annex 1 | |
| E4 | Utility data (water, gases, compressed air) within limits for the windows | <<FILL>> | GMP | |
| E5 | No facility-level event (utility failure, recall of shared component) touches the batch | <<FILL>> | GMP |
Section F: Regulatory conformance
| # | Item | Pass / Fail / NA | Evidence reference | Basis |
|---|---|---|---|---|
| F1 | Batch made and tested per the registered or authorised process and specifications | <<FILL>> | Marketing authorisation / IND / IMPD | |
| F2 | Any process change was approved and, where required, notified before commercial use | <<FILL>> | Variation / change procedure | |
| F3 | For imported product, supply chain and QP-to-QP confirmation chain in place | <<FILL>> | Annex 16 | |
| F4 | Parametric or real-time release, where used, is registered and its parameters in range | <<FILL>> | Annex 17 |
Signoff
| Field | Entry |
|---|---|
| All items Pass or NA (with reason), or Fails routed and resolved | Yes / No |
| Open items blocking release | <<FILL: none, or list>> |
| Reviewer (name, signature, date) | <<FILL>> |
| Forwarded to disposition authority on | <<FILL: date>> |
Acceptance criteria
The package is ready for a disposition decision when every item is Pass or a justified NA, or any Fail has been resolved through the deviation or investigation process, and the reviewer has signed and forwarded the checklist to the disposition authority.
Filled specimen (extract)
The following shows a completed extract for an illustrative solid oral dose batch. The batch and numbers are illustrative.
| # | Item | Pass / Fail / NA | Evidence reference |
|---|---|---|---|
| A1 | Executed batch record complete, no gap | Pass | BR-7781 pages 1-46 |
| A4 | Yield reconciled; compression yield 97.4 percent within 95 to 101 | Pass | BR-7781 p.31 |
| C2 | All results pass vs current spec | Pass | CoA-7781 (assay 99.8, dissolution Q+12) |
| C3 | One OOS on content uniformity investigated and closed, assignable cause | Pass | OOS-2026-0091 closed |
| D2 | Two deviations: DEV-0201 closed; DEV-0209 open with signed batch-impact assessment | Pass | DEV-0201, DEV-0209 |
| E2 | Shared blender cleaning validated; cleaning record signed | Pass | CLN-7781 |
| F1 | Conforms to registered process; no unapproved change | Pass | MA ref, change log reviewed |
The reviewer here caught that DEV-0209 was still open, confirmed its batch-impact assessment was signed and concluded no adverse effect, and only then forwarded the package. If DEV-0209 had lacked a batch-impact conclusion, item D2 would read Fail and release would be blocked.
Common inspection findings this checklist prevents
- Release with a linked deviation whose batch impact was never assessed.
- An OOS left open, or retested into compliance, at the point of release.
- Equipment used out of calibration or a lapsed cleaning validation not caught before release.
- A process change in effect during manufacture that was never approved.
- A checklist signed with items left blank rather than marked Pass, Fail, or NA with a reason.
How to adapt this checklist
- Add or remove rows to match your product type (delete sterile-only rows for a non-sterile oral product; keep Annex 1 rows for aseptic fill).
- Replace the generic Basis cites with your own SOP numbers alongside the regulation.
- Set your rule for who may complete the checklist versus who signs the disposition, preserving segregation of duties.
- Confirm each regulation reference against the current published version before issue.