Purchasing Controls – Medical Device GMP

21 CFR 820 Subpart E of the Code of Federal Regulations (CFR) outlines the specific requirements for purchasing controls in the quality system regulations for medical device manufacturers in the United States. These regulations are enforced by the Food and Drug Administration (FDA) to ensure that manufacturers establish and maintain processes for the proper control of purchased components and materials used in the production of medical devices. The goal is to ensure that these components and materials meet specified quality standards to ensure the safety and effectiveness of medical devices.

Below are the key elements and requirements for Purchasing Controls:

  • Purchasing Process: Manufacturers must establish and maintain procedures to ensure that all purchased components, materials, and services meet specified requirements. This includes ensuring that the suppliers of these items are also qualified.

  • Supplier Evaluation: Manufacturers are required to evaluate and select suppliers based on their ability to meet quality requirements. This evaluation should consider factors such as the supplier's history of performance and the quality of their products or services.

  • Supplier Audits: Manufacturers may conduct supplier audits as necessary to ensure that suppliers are in compliance with quality requirements.

  • Purchase Orders: Purchase orders must include all necessary information, including specifications, drawings, quality requirements, and other relevant information to communicate the manufacturer's expectations to the supplier.

  • Receiving Inspection: Manufacturers must have procedures in place for inspecting and verifying the quality of incoming components and materials. These procedures should include sampling plans, inspections, and acceptance criteria.

  • Acceptance or Rejection of Materials: Manufacturers must establish criteria for the acceptance or rejection of incoming materials and components. Any non-conforming items should be properly documented and addressed.

  • Documentation: Records of supplier evaluations, purchase orders, inspection results, and other relevant information must be maintained and made available for review by regulatory authorities.

  • Traceability: Manufacturers should establish and maintain procedures to ensure traceability of purchased components and materials. This is crucial for tracking and identifying any issues that may arise with these items.

  • Notification of Changes: Manufacturers should be notified of any changes made by their suppliers that could affect the quality of purchased components or materials.

  • Supplier Non-Conformance: Procedures should be in place for addressing and documenting instances of supplier non-conformance. Manufacturers should work with suppliers to resolve these issues effectively.

  • Records Retention: Records related to purchasing controls should be retained for a specified period, typically at least one year after the expiration date of the medical device.

These requirements are designed to ensure that manufacturers have robust processes in place to control and verify the quality of purchased components and materials. Compliance with these regulations is crucial for maintaining the safety and effectiveness of medical devices and for meeting FDA regulatory requirements.

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