Certificate of analysis: the documents that come with a packaging batch
A batch of bottles arrives at the laboratory. Before the cartons are even opened, the quality department reads one document: the certificate of analysis. It says what was checked, on which batch, with which results, and it often decides what happens next.
By Tecmom editorial team · 2 min read
What a certificate of analysis says
A certificate of analysis (CoA) is a document issued by the manufacturer's quality department. It attests that a specific batch meets its specification, by giving the actual results of the checks carried out on that batch.
For a batch of packaging, it usually shows the reference and batch number, the production date, the material batch used, then the checks: appearance, dimensions, weight, functional tests such as leak tightness, each with its expected value and the value obtained. The document is dated and signed.
Certificate of analysis or certificate of conformity
The two terms are often confused, but they do not say the same thing. A certificate of conformity declares that the batch meets the specification, without giving details. A certificate of analysis shows the results.
The latter lets the customer track values from batch to batch and spot a drift before it becomes a deviation. The specification states which one is expected.
What the laboratory does with it
A certificate does not remove the need for all checks. US good manufacturing practice, at § 211.84, accepts one for containers and closures on two conditions: the laboratory carries out at least a visual identification of each batch, and it checks the reliability of the supplier's results at appropriate intervals. European GMP likewise relies on supplier qualification.
In practice, the laboratory compares the certificate with its specification, carries out its own incoming checks, often by sampling according to AQL, and periodically repeats the full tests to confirm the supplier's figures.
Trust is built upstream
A certificate is worth what the system behind it is worth: test methods, calibrated instruments, batch traceability. This is what the supplier audit checks, and what ISO 15378 governs for primary packaging.
The certificate is also one of the documents the laboratory adds to its dossier; see what AMMPS expects of packaging.
A certificate of analysis is a single page. Behind that page lies a whole system that a customer always ends up checking.
Glossary
- Certificate of analysis
- A document giving a batch's test results against its specification.
- Certificate of conformity
- A declaration that a batch complies, without the detailed results.
- Specification
- The list of expected characteristics and their acceptance limits.
- Traceability
- The ability to trace a batch's origin, material and history.