According to the Code of Federal Regulations (CFR) section 21 CFR 820.50, each manufacturer shall establish and maintain procedures to ensure that all purchased or otherwise received product and services conform to specified requirements. The manufacturer should establish and maintain requirements that these suppliers must meet. The suppliers must be evaluated against your supplier approval program and the evaluation should be documented. The manufacturer should maintain records for approved suppliers. These records should include supplier agreement to notify the manufacturer of changes in the product or service so that manufacturers may determine whether the changes may affect the quality of a finished device.
A company recently received the following observation:
…. Requirements that must be met by suppliers have not been adequately established.
Specifically, your firm’s procedure, SOP …, “Purchasing”, specifies the record of Approved Vendors will take the form of an Approved Suppliers List (ASL). Vendor approval must be reviewed at least … and will be based on …. The results of the review will be recorded and addressed at Management Review. The scope of the … performance review was not defined, and there was no documentation of the results of the … performance reviews over the last 3 years. In addition, there was no documentation other than evidence of registration for the initial vendor approval for two (2) out of three (3) vendors reviewed, to include an industrial parts and services supplier and the vendor for the critical component of the … device.
For additional information pertaining to supplier approval, purchasing controls, refer to FDA presentations: Purchasing Controls, presented by the FDA Small Business Regulatory Education for Industry (REdI) Conference. As well as Purchasing Controls, presented by CDRH and Purchasing Controls Presented to ORA Annual Conference 2022.
To view more observations pertaining to purchasing and supplier evaluation, refer to the following GMP Trends® Issues: 1111, 1106, 1105, and 1104.
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