Manufacturing Excellence: Navigating 21 CFR 820.70 for Medical Devices

21 CFR 820.70 specifically deals with "Production and Process Controls" within the Quality System Regulation (QSR) for medical devices. These controls are crucial for ensuring that medical devices are manufactured in a consistent and controlled manner, meeting the required quality standards and specifications.

 Here's a more detailed breakdown of what 21 CFR 820.70 covers:

 1. General Requirements: Establishing and maintaining procedures to ensure that devices are manufactured in accordance with their specifications.

 2. Production Processes: Documenting procedures for controlling production processes, including those related to equipment, materials, and personnel.

 3. Process Validation: Validating production processes to ensure that they consistently produce devices meeting predetermined specifications.

 4. Monitoring and Control: Establishing procedures for monitoring and controlling process parameters to ensure product quality and consistency.

 5. Equipment Calibration and Maintenance: Establishing procedures for ensuring that production equipment is calibrated, maintained, and used appropriately.

 6. Handling, Labeling, Packaging, and Storage: Implementing procedures to prevent mix-ups, damage, deterioration, or contamination during handling, labeling, packaging, and storage of devices.

 Compliance with these regulations is essential for manufacturers to demonstrate that their medical devices are safe, effective, and of high quality, as required by the U.S. Food and Drug Administration (FDA).

Citations:

What Does Process validation Mean to the FDA? - Compliance Group Inc

21 CFR Part 820 vs ISO 13485 | Compliance Group Inc

Location: United States

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