Document Controls – Medical Device GMP

21 CFR 820 Subpart D of the Code of Federal Regulations (CFR) addresses "Document Controls" and contains regulations that outline the requirements for medical device manufacturers to establish and maintain control over their documentation and records related to the production and quality management of medical devices. These regulations, enforced by the Food and Drug Administration (FDA), are essential for ensuring the integrity, accuracy, and availability of critical documentation throughout the device's lifecycle.

Here are key elements and requirements outlined in 21 CFR 820 Subpart D - Document Controls:

  • Document Approval and Distribution: Manufacturers must establish procedures for the approval, review, and distribution of documents, including design and manufacturing documents. These procedures should ensure that only approved and up-to-date documents are used.

  • Document Changes: Procedures must be in place to control changes made to documents, including the identification, review, and approval of changes. Changes should be documented and maintained.

  • Document Retrieval: Manufacturers should have procedures to ensure that documents are readily available where and when they are needed. This includes document retrieval from storage or electronic systems.

  • Documenting Device Specifications: Device master records (DMRs) must be established, including specifications and procedures for manufacturing and quality assurance.

  • Device History Records (DHRs): DHRs should be established for each batch or lot of devices produced, containing records of the production process, including dates, quantities, and identification of all components used.

  • Document Maintenance: Procedures should be in place to ensure that documents, including records of design changes and device history records, are maintained throughout the required retention period.

  • Obsolete Documents: Procedures must be established for the identification and handling of obsolete documents to prevent their unintended use.

  • Quality System Records: Manufacturers should maintain quality system records, including records of management reviews, quality audits, corrective and preventive actions (CAPAs), and supplier evaluations.

  • Electronic Document Controls: If electronic systems are used for document control, manufacturers should establish and maintain procedures to ensure the security, integrity, and availability of electronic documents.

  • Records Retention: Records related to document controls and other quality system requirements should be retained for a specified period, typically at least one year after the expiration date/life of the medical device.

  • Training: Manufacturers should provide training to personnel to ensure they understand and follow document control procedures.

These requirements in Subpart D are fundamental to ensuring the consistency, accuracy, and accessibility of documentation throughout the medical device manufacturing process. Compliance with these regulations is essential for maintaining product quality and safety, as well as for meeting FDA regulatory requirements

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