Supplier Certificates of Conformity: Are They Sufficient?

Q: Is it acceptable to use supplier Certificates of Conformity sent with their products as evidence they were manufactured per specifications? I’m getting questions about products supplied by our OEMs and contract manufacturers. This has been our approach in the past, but I’d like to get your thoughts on this.

A: Your acceptance of a supplier Certificate of Conformity or Certificate of Analysis should be based on how much you trust that certification.

For pharmaceuticals, FDA expects manufacturers to test products received — initially and periodically — to assure and demonstrate the truthfulness of the Certificate.

For medical devices, this expectation has not always been applied, except for some in-vitro diagnostics.

If you accept a Certificate of Conformity, my recommendation is — at the very least — you audit the OEM or contract manufacturer to verify the firm has a well documented and controlled quality system. In addition, your audit should determine if the firm has the capability to test product at the in-coming, in-process and finished product stages, and if it uses validated or well characterized manufacturing processes.

Basically, a Certificate of Conformity offers you very little data to evaluate. The Certificate usually just says the product or material meets your specifications or the specs of a known standard. On the other hand, a Certificate of Analysis provides more useful data, including the actual specifications of the product or at least confirmation that the specs fall within a defined range. A Certificate of Analysis also normally provides information about known levels of deviations or contaminants. This information is especially helpful when you’re comparing similar products from different suppliers.

Generally, FDA prefers to see Certificates of Analysis rather than Certificates of Conformity.

Generally, FDA prefers to see Certificates of Analysis rather than Certificates of Conformity. If you rely only on a Certificate of Conformity, be prepared to demonstrate to FDA that you’ve adequately qualified the supplier to provide accurate representations of its products or materials, and that you know the supplier adequately tests the product or material.

Personally, I recommend you use a Certificate of Conformity only for products or materials that are not essential outputs — or for which you can adequately determine the veracity of the product and material at in-coming, in-process or finished product acceptance.

For example, materials such as raw metal stock, bars or coiled wire may be accepted with Certificates of Conformity if you believe your manufacturing process will detect any deficiency in the chemical composition or the proper making of the metal or wire. If not, then a minimum requirement should be a Certificate of Analysis rather than one of conformance.

But to reiterate: FDA is OK with your acceptance of either a Certificate of Conformity or a Certificate of Analysis, as long as your supplier quality management process is sufficient to ensure the veracity of the Certificate.

Answered by Denise Dion, EduQuest VP of Regulatory and Quality Services (18 years as an FDA investigator and co-editor of FDA’s Investigations Operations Manual) and instructor of EduQuest’s The CAPA Clinic: Effective CAPA Systems, Failure Investigations and Complaint Management.

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