This is a ready-to-use screening checklist for a Certificate of Analysis that shows a pattern worth a second look before you release material on its basis. It supplements, and does not replace, the standard incoming review in the CoA incoming review checklist. Replace every <<FILL: ...>> placeholder, mark each item Pass, Fail, or N/A, and route the completed screening through your normal review and approval. A filled specimen follows. This is general guidance to adapt and verify, not legal or regulatory advice.
When to run this screening
Run it on a defined periodic sample of an established supplier’s certificates, on the early lots of any new supplier, and any time a routine CoA review turns up something that does not sit right: a result that looks too clean, a certificate that looks slightly different from the last one, or a supplier that hesitates when asked a direct question about a result. A Fail on any single item below is not proof of fraud. It is a reason to verify before the lot is released on the certificate alone.
Header
| Field | Entry |
|---|---|
| Material and grade | <<FILL>> |
| Supplier / manufacturer | <<FILL>> |
| Lot number | <<FILL>> |
| CoA reference | <<FILL>> |
| Trigger for this screening | Routine periodic sample / New supplier / Result pattern / Other: <<FILL>> |
| Reviewer | <<FILL>> |
| Date | <<FILL>> |
1. Result pattern
| # | Item | Pass / Fail / NA |
|---|---|---|
| 1.1 | Results across the last <<FILL: e.g. 10>> lots show ordinary analytical scatter rather than suspiciously uniform values | |
| 1.2 | No repeated clustering of results near the mid-point of the acceptance range across multiple lots | |
| 1.3 | Result precision (decimal places, rounding behavior) is consistent with what the cited method can actually produce |
2. Document integrity
| # | Item | Pass / Fail / NA |
|---|---|---|
| 2.1 | Method reference and specification version present for every test on the certificate | |
| 2.2 | Letterhead, logo, layout, and signature are consistent with prior certificates received from this source | |
| 2.3 | Analysis date is consistent with the manufacture date and with the cited method’s known run time | |
| 2.4 | Certificate is not a reissue of a prior lot’s certificate with only the lot number changed |
3. Source and chain verification
| # | Item | Pass / Fail / NA |
|---|---|---|
| 3.1 | Certificate origin confirmed through a contact already on file in the supplier qualification record, not through contact information printed on the certificate | |
| 3.2 | Any distributor or repackager in the chain is confirmed against the named manufacturer’s own records | |
| 3.3 | Underlying raw data was made available within a reasonable time when requested |
4. Escalation
| # | Item | Pass / Fail / NA |
|---|---|---|
| 4.1 | Any Fail above documented with the specific observation, not a general impression | |
| 4.2 | Required per-lot in-house identity or visual check performed and reconciled against the CoA claim, regardless of the outcome above | |
| 4.3 | Lot held pending resolution; not released on the certificate alone while a Fail is open | |
| 4.4 | Supplier quality notified of any Fail | |
| 4.5 | CoA discrepancy investigation opened for any confirmed or unresolved Fail, per <<FILL: SOP-ID>> |
Signoff
| Role | Name | Signature | Date |
|---|---|---|---|
| Reviewer | <<FILL>> | ||
| QA approver | <<FILL>> |
References
ICH Q7, Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients, Section 11.4 (a certificate must present the genuine results actually obtained on that batch). 21 CFR 211.84(d)(2) and (d)(3) (the per-lot in-house check applies regardless of supplier reliability and is never waived on the strength of a certificate alone). FDA Guidance for Industry, Testing of Glycerin, Propylene Glycol, Maltitol Solution, Hydrogenated Starch Hydrolysate, Sorbitol Solution, and Other High-Risk Drug Components for Diethylene Glycol and Ethylene Glycol (2023, superseding the 2007 glycerin-specific guidance), illustrating why a specific identity and limit test catches an adulterated raw material that a certificate’s conformance statement alone does not.
Confirm the current version and clause numbers of each reference before issue.
Filled specimen
The following shows the screening completed for an example excipient supplier whose recent certificates prompted a second look. Names and numbers are illustrative.
Header: Material “Example excipient, USP grade”; supplier ASL-071; lot EXC-2609-014; CoA reference CoA-EXC-2609-014; trigger: result pattern, the assay result read identical to two decimal places on the last four certificates; reviewer T. Alaba; date 22 September 2026.
| # | Item | Pass / Fail / NA |
|---|---|---|
| 1.1 | Ordinary scatter across last 10 lots | Fail (assay 99.40% identical on 4 of the last 5 certificates) |
| 2.1 | Method and spec version present | Pass |
| 2.2 | Letterhead/format consistent | Pass |
| 3.1 | Origin confirmed through supplier qualification contact | Fail (call placed; the manufacturer’s quality contact had no record of this lot’s certificate being issued from their system) |
| 4.3 | Lot held | Pass, held |
| 4.5 | Investigation opened | DEV-2026-0388 |
Outcome: the manufacturer’s own quality department could not locate the certificate in its issuing system, and the repeating assay value confirmed the concern was warranted rather than coincidental. The lot was held, the distributor who supplied the certificate was queried, and the finding was escalated to a full supplier audit rather than accepted on the strength of a document that looked complete on its face.
Common inspection findings this checklist prevents
- A run of suspiciously identical or mid-range results accepted lot after lot with no one asking why.
- Certificate authenticity “confirmed” by calling a number printed on the certificate itself, which a fabricated certificate can fabricate just as easily.
- A supplier’s inability or refusal to produce underlying raw data treated as a minor inconvenience rather than a signal.
- No screening performed on a new supplier’s early lots, when the relationship is least proven.
How to adapt this checklist
- Set your own periodic sampling frequency for established suppliers based on material risk.
- Add material-specific red flags where a known adulteration history exists for that material class, for example a DEG/EG limit test line for glycerin and glycerin-based components.
- Point the escalation reference in item 4.5 to your own CoA discrepancy investigation procedure.
- Confirm every regulation and guidance cited against the current published version before issue.