Glossary
Certificate of Analysis (CoA)
A document issued, dated, and signed by the quality unit for each batch, setting out which tests were performed, against what criteria, and what the results were.
Details
Under ICH Q7 §§11.41–11.43 a certificate of analysis states the material name, grade, batch number, and release date (including the expiry or retest date), lists each test performed under the compendial or customer requirement together with the acceptance criteria and the numerical result, is dated and signed by an authorised person of the quality unit, and carries the name, address, and telephone number of the original manufacturer; where a repacker or reprocessor did the testing, that fact and the original manufacturer are both shown (§11.43), and a certificate newly issued by an agent must also preserve the original manufacturer's information (§11.44). If a specification says what must be tested and what it must meet, the certificate of analysis is the per batch document saying that this batch actually met it. 21 CFR 211.84(d)(2) allows a supplier's certificate to be accepted in place of full in-house testing only where the manufacturer performs at least one specific identity test on each component itself and establishes the reliability of the supplier's results by validating them at appropriate intervals. Inspections cite components released on a certificate alone with no identity test, missing records validating supplier certificates (periodic full testing), and, as in the Canadian finding of no authentic certificate of analysis, having only an agent's certificate rather than the original manufacturer's.
Related sections
Related terms
Real inspection findings
Findings from regulators' inspection documents in which this term appears.
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You relied on your supplier’s certificate of analysis (COA) in lieu of testing…
FDA · FDA Warning Letter · 2023-02-28 -
Failure to test the identity of each batch of incoming production material and appropriately qualify suppliers to rely upon their Certificate of Analysis.
FDA · FDA Warning Letter · 2026-03-17 -
The company applied for a GMP certificate with the scope of non-sterile medicinal products, including capsules, hard shell; tablets (coated and uncoated); sachets and pellets.
EMA · EU GMP NCR (EudraGMDP) · 2023-01-17
