This is a ready-to-use Certificate of Analysis (CoA) you issue when your site tests and ships material (API, drug substance, finished product, or as a contract lab). It carries every field a receiving reviewer expects. Replace every <<FILL: ...>> placeholder, generate the values from your source system rather than retyping them, and route the certificate through independent QA review before release. A filled specimen follows. This is general guidance to adapt and verify, not legal or regulatory advice.
When to use this versus a Certificate of Compliance
Issue a Certificate of Analysis when the receiving party needs the actual numeric results to make its own conformance decision (the normal case for tested materials). Issue a Certificate of Compliance / Conformance only when the attribute is a statement rather than a measured value (for example a grade or origin claim). A CoC does not support release of an attribute that requires a numeric result.
Certificate header
| Field | Entry |
|---|---|
| Issuing party name and address | <<FILL: legal manufacturer / lab name and address>> |
| Certificate number | <<FILL: unique CoA number>> |
| Certificate version / issue date | <<FILL: version and date of issue>> |
| Material name and grade | <<FILL: e.g. Sodium chloride, USP>> |
| Manufacturer item / part number | <<FILL>> |
| Lot / batch number | <<FILL>> |
| Batch size / quantity | <<FILL>> |
| Manufacture date | <<FILL>> |
| Retest / expiry date | <<FILL>> |
| Specification reference and version | <<FILL: spec ID and version tested against>> |
| Date(s) of analysis | <<FILL>> |
Results table
Every row ties to a controlled analytical record. Report the value that appears in the source data, applying only the documented rounding convention.
| Test | Method / reference | Acceptance criterion | Result | Units | Pass / Fail |
|---|---|---|---|---|---|
<<FILL: Identification>> | <<FILL: e.g. IR per USP <197>>> | <<FILL: Conforms to reference>> | <<FILL>> | <<FILL>> | <<FILL>> |
<<FILL: Assay>> | <<FILL: method>> | <<FILL: e.g. 98.0-102.0 %>> | <<FILL>> | <<FILL: %>> | <<FILL>> |
<<FILL: Water / loss on drying>> | <<FILL: e.g. USP <921> or <731>>> | <<FILL: NMT X %>> | <<FILL>> | <<FILL>> | <<FILL>> |
<<FILL: Residue on ignition>> | <<FILL: USP <281>>> | <<FILL: NMT X %>> | <<FILL>> | <<FILL>> | <<FILL>> |
<<FILL: Elemental impurities>> | <<FILL: USP <232>/<233>>> | <<FILL: NMT X ppm>> | <<FILL>> | <<FILL>> | <<FILL>> |
<<FILL: Microbial limits (TAMC/TYMC)>> | <<FILL: USP <61>>> | <<FILL: NMT X CFU/g>> | <<FILL>> | <<FILL>> | <<FILL>> |
<<FILL: add rows as the specification requires>> |
Overall conclusion
| Field | Entry |
|---|---|
| Overall disposition | <<FILL: Conforms / Does not conform to specification>> |
| Storage conditions | <<FILL>> |
| Any out-of-specification result investigated and resolved | Yes / No / N/A |
Approval
| Role | Name | Signature | Date |
|---|---|---|---|
| Analyst / data generated by | <<FILL>> | ||
| QC reviewer (calculations, integrations, method compliance) | <<FILL>> | ||
| QA / authorized release of certificate | <<FILL>> |
Issuance rules (the controls behind a genuine CoA)
- Complete all testing per validated or compendial methods with full laboratory records meeting 21 CFR 211.194 (raw data, calculations, instrument output, analyst identity, review).
- Any out-of-specification result goes through the OOS investigation and is resolved before a conforming certificate can issue. Never issue a “conforms” CoA over an unresolved OOS.
- Transfer results electronically from the source system (LIMS, chromatography data system) rather than transcribing them by hand. Manual transcription is the leading CoA data integrity risk.
- Populate every header and results field, including the method reference and the specification version in force at the time of test.
- Reconcile the certificate against the source records: every reported value must trace to a specific analytical record and match it exactly.
- Independent QA review and approval before release: a second qualified person, not the analyst who generated the data, checks the certificate against the underlying records.
- Tie the released certificate to the released lot and retain it for the required retention period.
References
21 CFR 211.194 (laboratory records) and 211.165 (testing and release for distribution). 21 CFR 211.192 (production record review) for OOS handling before issuance. ICH Q7, Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients, Section 11.4 (certificates of analysis). ISO/IEC 17025 test-report content requirements where the issuer is an accredited contract laboratory.
Confirm the current version and clause numbers of each reference before issue.
Filled specimen
The following shows a completed certificate for an example purified excipient lot. Company, lot, and numbers are illustrative.
Header: Issuer “Example Manufacturer, City, Country”; certificate CoA-MNT-2606-041 v1.0, issued 12 June 2026; material Mannitol USP/EP; item MFG-MNT-01; lot MNT-2606-041; batch size 500 kg; manufactured 08 June 2026; retest 08 June 2029; specification SPEC-MFG-MNT-01 v3.0; analyzed 10-11 June 2026.
| Test | Method / reference | Acceptance criterion | Result | Units | Pass / Fail |
|---|---|---|---|---|---|
| Identification | IR per USP <197> | Conforms to reference | Conforms | - | Pass |
| Assay | Titration | 98.0-102.0 % | 99.6 | % | Pass |
| Loss on drying | USP <731> | NMT 0.30 % | 0.12 | % | Pass |
| Residue on ignition | USP <281> | NMT 0.10 % | 0.03 | % | Pass |
| Elemental impurities | ICP per USP <232>/<233> | NMT 10 ppm | 3 | ppm | Pass |
| Microbial limits (TAMC) | USP <61> | NMT 1000 CFU/g | < 10 | CFU/g | Pass |
Overall: Conforms to specification. Stored at controlled room temperature. No OOS. Analyst A. Silva; QC reviewer M. Roy; QA release R. Gomez, 12 June 2026.
Note how each result carries its units and each test names the compendial method. The receiving site will judge these results against its own specification, which may be tighter than the issuer’s; issuing against a genuine, current specification with correct method references is what makes the certificate defensible on both ends.
Common inspection findings this template prevents
- A certificate missing method references or the specification version, so the receiver cannot confirm what was tested against what.
- Values that cannot be traced to a specific analytical record, or that differ from the raw data.
- A “conforms” certificate issued while an OOS result on the lot was never investigated.
- Manual transcription errors from the chromatography data system onto the certificate.
- The same person generating and releasing the certificate, with no independent review.
How to adapt this template
- Replace the illustrative test rows with your material’s actual specification tests, in specification order.
- Wire the results table to your LIMS or chromatography data system output so values are transferred, not retyped.
- Add any product-specific fields (for example potency for a biologic, endotoxin for a sterile material).
- If you issue electronic certificates, place the system under 21 CFR Part 11 / EU Annex 11 controls and preserve the audit trail.
- Confirm every regulation and compendial chapter against the current published version before issue.