A certificate of analysis, or COA, reports test results for a material, batch or product against stated characteristics. The issuer, methods and data determine how much confidence the buyer can place in it.
How should a business apply Certificate of Analysis (COA)?
Specify required tests, limits, methods, units and batch linkage. Decide when supplier results need independent confirmation.
What records support Certificate of Analysis (COA)?
Retain the original COA, batch or lot, manufacture date where relevant, test methods, results, specification and authorized issuer.
Certificate of Analysis (COA): control and evidence
| Area | What the record should show |
|---|---|
| Control | Specify required tests, limits, methods, units and batch linkage. Decide when supplier results need independent confirmation. |
| Evidence | Retain the original COA, batch or lot, manufacture date where relevant, test methods, results, specification and authorized issuer. |
| Tradeoff | A generic certificate or copied result without lot traceability does not establish that the delivered material was tested. |
What should buyers verify about Certificate of Analysis (COA)?
A generic certificate or copied result without lot traceability does not establish that the delivered material was tested.
