A certificate of analysis (CoA) is a document from a supplier or lab that reports test results for a specific lot of material against its specification. In GMP manufacturing, a CoA supports your decision to release a material but never replaces it: you still verify identity, confirm the results meet your own specification, and document a qualified disposition.
What a CoA should include
- Supplier or manufacturer name and address
- Material name and code
- Lot or batch number
- Manufacture and expiration or retest dates
- Each test performed, with its method
- The specification limit for each test
- The actual result, with units
- Date and signature of the authorized quality person
When the regulations let you rely on a CoA
For drugs, 211.84(d)(2) allows reliance on a supplier's CoA if you run at least one specific identity test on each component lot and periodically validate the supplier's results. For dietary supplements, 111.75(a)(2) allows reliance for specifications other than dietary ingredient identity once you qualify the supplier and periodically reconfirm. See the Part 211 and Part 111 guides.
How to review a CoA, step by step
- Confirm it matches the shipment: material, supplier, lot, and quantity
- Check that it is current, dated, and signed
- Pull your active specification, not the supplier's
- Compare every parameter, limit, unit, and method
- Flag missing tests and out-of-specification results
- Confirm the supplier's qualification is current
- Run the identity testing your regulation requires
- Document the review and route it for disposition: release, quarantine, or reject
Red flags on a CoA
- Results identical across different lots
- Tests on your specification missing from the CoA
- Methods or units that differ from your specification
- "Conforms" with no numeric result
- Lot numbers that do not match the container labels
- No date or signature
From CoA review to material disposition
Reviewing the CoA is one input. Disposition also weighs supplier status, identity results, open findings, and your procedures. Ovada's incoming material disposition skill does the comparison and evidence gathering, and a qualified person makes the call.
Questions
Can we release material based on a CoA alone?
No. Both Part 211 and Part 111 require identity testing you perform or control, plus a qualified supplier, before you can rely on a CoA for other attributes. Release is a documented decision by your quality unit.
What is the difference between a CoA and a certificate of conformance?
A CoA reports actual test results for a specific lot. A certificate of conformance only states that the product meets its specification, without reporting results.
Who should sign a certificate of analysis?
An authorized quality control or quality assurance person at the supplier or testing lab that issued it, with the date of signing.