According to the Preamble to the Good Manufacturing Practices (GMPs), the intent of a supplier evaluation program is to ensure that manufacturers select only those suppliers, contractors, and consultants who have the capability to provide quality product and services. The Code of Federal Regulations (CFR) section 21 CFR 820.50 states, each manufacturer shall establish and maintain procedures to ensure that all purchased or otherwise received product and services conform to specified requirements.
(a). Evaluation of suppliers, contractors, and consultants. Each manufacturer shall establish and maintain the requirements, including quality requirements, that must be met by suppliers, contractors, and consultants. Each manufacturer shall:
(1) Evaluate and select potential suppliers, contractors, and consultants on the basis of their ability to meet specified requirements, including quality requirements. The evaluation shall be documented.
(2) Define the type and extent of control to be exercised over the product, services, suppliers, contractors, and consultants, based on the evaluation results.
(3) Establish and maintain records of acceptable suppliers, contractors, and consultants.
(b) Purchasing data. Each manufacturer shall establish and maintain data that clearly describe or reference the specified requirements, including quality requirements, for purchased or otherwise received product and services. Purchasing documents shall include, where possible, an agreement that the suppliers, contractors, and consultants agree 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. Purchasing data shall be approved in accordance with § 820.40.
A company recently received the following observation:
….. Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have not been adequately established.
Specifically, you stated during the inspection that not all complaints received by phone are documented and you indicated on your complaint tracking log that only 15 out of 37 complaints received further documentation. Your firm is not using the designated complaint form per your complaint procedures in your quality manual to document complaints. You do not evaluate your complaints to determine whether the complaints represent an event which is required to be reported as a medical device report. Your complaint forms do not indicate a date for which you became aware of the complaint, not do they indicate a date the complaint was closed.
For additional information pertaining to purchasing controls, refer to FDA presentation: Purchasing Controls. You can also refer to FDA’s Dashboards for Firm/Supplier Evaluation Resources. Here you can find information on a supplier’s inspections, compliance actions, recalls and import alerts.
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