This is a ready-to-use checklist that forces every step of a Certificate of Analysis (CoA) review so nothing is silently skipped. Use it alongside SOP: Certificate of Analysis Review and Incoming Material Disposition. Replace every <<FILL: ...>> placeholder, mark each item Pass, Fail, or N/A, and route the completed checklist through your normal review and approval. A filled specimen follows. This is general guidance to adapt and verify, not legal or regulatory advice.
How to use
Complete one checklist per incoming lot. Any Fail routes the lot to quarantine and a deviation, not to release. The checklist is retained with the CoA and the in-house test data as part of the release package.
Header
| Field | Entry |
|---|---|
| Material name and grade | <<FILL>> |
| Internal material code | <<FILL>> |
| Supplier / manufacturer | <<FILL>> |
| Lot number | <<FILL>> |
| Specification number and version | <<FILL>> |
| Reviewer | <<FILL>> |
| Date | <<FILL>> |
1. Identity and lot match
| # | Item | Reference | Pass / Fail / NA |
|---|---|---|---|
| 1.1 | CoA lot number matches the physical container labels | 21 CFR 211.84 | |
| 1.2 | CoA material name and grade match the purchase order and packing slip | 211.84 | |
| 1.3 | One CoA covers only this lot (not multiple lots on one certificate) | 211.84 | |
| 1.4 | CoA is not a certificate copied forward from a prior lot | ICH Q7 11.4 |
2. Source qualification
| # | Item | Reference | Pass / Fail / NA |
|---|---|---|---|
| 2.1 | CoA issuer is a qualified manufacturer on the approved supplier list | 211.84(d) | |
| 2.2 | Supply chain (including any distributor or repackager) is qualified end to end | 211.84(d) | |
| 2.3 | A quality agreement covering CoA content is in place with the supplier | ICH Q7 |
3. Specification linkage
| # | Item | Reference | Pass / Fail / NA |
|---|---|---|---|
| 3.1 | Current internal specification pulled; number and version recorded | 211.160 | |
| 3.2 | Every test in the current specification is present on the CoA | 211.84 | |
| 3.3 | Each CoA acceptance limit meets or is tighter than your specification limit | 211.84 | |
| 3.4 | Each test lists the method or compendial reference used | ICH Q7 11.4 |
4. Result-by-result review
| # | Item | Reference | Pass / Fail / NA |
|---|---|---|---|
| 4.1 | Every result meets YOUR acceptance criterion (not the supplier’s looser limit) | 211.84 | |
| 4.2 | Units checked on every numeric result | 211.194 | |
| 4.3 | Limit direction checked (not-more-than vs not-less-than; range boundaries) | 211.160 | |
| 4.4 | Descriptive tests (appearance, identification) match the required outcome | 211.84 | |
| 4.5 | No unresolved out-of-specification result underlies a “conforms” conclusion | 211.192 |
5. Per-lot in-house check
| # | Item | Reference | Pass / Fail / NA |
|---|---|---|---|
| 5.1 | Required per-lot check performed (identity for components; visual for containers/closures) | 211.84(d)(2), (d)(3) | |
| 5.2 | Material sampled per the applicable sampling plan | 211.84(b) | |
| 5.3 | In-house result matches the CoA identity claim | 211.84(d) |
6. Lifecycle and dates
| # | Item | Reference | Pass / Fail / NA |
|---|---|---|---|
| 6.1 | Date of analysis follows the manufacture date | ICH Q7 11.4 | |
| 6.2 | Expiry or retest date assigned from the CoA | 211.137 |
7. Disposition
| # | Item | Reference | Pass / Fail / NA |
|---|---|---|---|
| 7.1 | Disposition recorded (release / reject / hold), signed and dated | 211.84, 211.87 | |
| 7.2 | Deviation opened for any Fail above | <<FILL: SOP-ID for deviations>> | |
| 7.3 | CoA, in-house data, spec version, and disposition retained together | 211.180 |
Signoff
| Role | Name | Signature | Date |
|---|---|---|---|
| Reviewer | <<FILL>> | ||
| QA approver | <<FILL>> |
Filled specimen
The following shows a completed checklist for an example API lot. The numbers and names are illustrative.
Header: Material “Example API, in-house spec grade”; code API-0031; supplier ASL-014; lot API-2605-118; spec SPEC-API-0031 v6.0; reviewer J. Mensah; date 18 June 2026.
| # | Item | Pass / Fail / NA |
|---|---|---|
| 1.1 | Lot matches container | Pass |
| 1.2 | Name/grade match PO and packing slip | Pass |
| 2.1 | Issuer qualified on ASL | Pass |
| 3.1 | Spec v6.0 pulled and recorded | Pass |
| 3.2 | All spec tests present on CoA | Fail (residual solvents test absent) |
| 4.1 | Results meet internal criteria | Pass for tests present |
| 5.1 | Identity by IR performed | Pass (conforms) |
| 7.1 | Disposition | Hold |
| 7.2 | Deviation opened | DEV-2026-0211 |
Outcome: item 3.2 failed because SPEC-API-0031 v6.0 requires a residual-solvents test (added when the synthesis route changed) that the supplier CoA did not cover. The reviewer held the lot, opened a deviation, and referred the gap to supplier quality to update the CoA template, rather than releasing on the tests that were present. This is the classic missing-test escape the checklist is designed to catch.
Common inspection findings this checklist prevents
- The silent-skip failure mode: a reviewer checks that present rows pass but never confirms every required test is on the certificate.
- Comparing to the supplier’s limit instead of the internal specification.
- No documented per-lot identity or visual check.
- Specification version not captured, so a later tightening is never applied at incoming.
- A “conforms” CoA accepted over an unresolved out-of-specification result on the same lot.
How to adapt this checklist
- Replace the generic reference cites with your own procedure numbers where you point to internal SOPs.
- Add material-type-specific rows (for example cold-chain condition checks for temperature-sensitive materials).
- If you use reduced or skip-lot testing, add a row confirming the lot’s testing level and that identity still ran.
- For electronic or structured CoAs, add a row confirming certificate authenticity and source.
- Confirm every regulation cited against the current published version before issue.