A company recently received the following observation:
…. Procedures to ensure that all purchased or otherwise received product and services conform to specified requirements have not been adequately established.
Specifically, SOP …, “Purchasing & Purchase Control” has not been adequately established as demonstrated by the following:
a. Not all vendors have been evaluated and approved as required (i.e. panel, antigen, microplate suppliers and service providers such as consultants);
b. No approved vendor list is maintained as required;
c. Type and extent of control of suppliers is not defined;
d. There is no agreement that the suppliers agree to notify your firm of changes in the production or service so that your firm may determine whether the changes affect the quality of finished devices.
According to the Code of Federal Regulations (21 CFR 820.50 Purchasing Controls), an effective vendor approval program must have the following features:
- All vendors (i.e. suppliers, contractors, consultants) must be evaluated as necessary to meet the requirements of the manufacturer.
- Each device manufacturer must evaluate and select potential vendors based on the vendors ability to meet the specified requirements, including quality requiems. The evaluation of the vendors must be documented in a vendor list.
- Records kept and maintained for acceptable vendors.
According to GMP Trends® Annual Reports, over the last 5 years the observations pertaining to equipment cleaning (21 CFR 820.50) have been in the top 10 observations cited by the FDA each year.
For more information on how to establish and maintain a purchasing program, refer to the following FDA presentation: Purchasing Controls
For more observations pertaining to medical devices, see our new Issue 1063 available today. It also has observations pertaining to quality systems, manufacturing controls, and APIs.
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