Certificate of Analysis


Q. As a manufacturer can I rely on a Certificate of Analysis (CofA) from my supplier?

A. Yes – But… as noted by USFDA in a recent warning letter:

You can rely on vendor CoA for quality attributes, provided you conduct at least one test to verify the identity of each component lot before use in the drug product manufacturing. Additionally, you should have established reliability of supplier’s analyses through adequate initial validation and subsequent verification of supplier’s test results at appropriate intervals.

Thus the ability to rely on a CofA is dependent on the firms independent verification of ID testing (21 CFR 211.84 (c)(6)(d)(1), and through qualification, both initial and periodic requalification, of the supplier.

Blindly accepting the CofA with no independent verification and qualification of the vendor is not permissible.