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Glossary

Certificate of analysis (CoA)

A document issued for a specific batch of material that lists the tests performed, the acceptance limits and the results obtained, authorised by the issuer's quality unit. It is the evidence of testing that travels with the batch.

Why it matters on a certificate

For most buyers the certificate is the only quality evidence that arrives with a shipment. Decisions about release, purchase and customs rest on it. That weight is exactly why it deserves a line-by-line check: identity, dates, limits, results and signatures all have to hold together before the document can support any decision at all.

A worked example

A drum of an excipient arrives with a certificate naming the material, the batch, twelve tests with limits and results, and a dated signature from the issuing laboratory's quality unit. A reviewer ties the batch number on the certificate to the drum label before reading any result.

Examples are synthetic and illustrative; any limits shown are not the requirements for any particular material.

The COA Validator checks the element this term describes on every certificate it reads, and reports what is present, what is missing and what does not add up.

See what the validator checks

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