Nonconforming Product – Medical Device GMP

21 CFR 820 Subpart I "Nonconforming Product" specifically addresses the handling of nonconforming products for the manufacture of medical devices.

Subpart I establishes procedures and requirements for identifying, segregating, evaluating, and controlling nonconforming products within a medical device manufacturing facility. Nonconforming products are those that do not meet established specifications or quality standards and may pose a risk to patient safety if used.

The key points typically covered are:

  • Identification and segregation: Manufacturers must have a system in place to identify and segregate nonconforming products to prevent them from being mixed with conforming products.

  • Evaluation and disposition: Manufacturers should establish procedures for evaluating nonconforming products to determine the extent of nonconformance and the potential impact on product safety and efficacy.

  • Documentation: Records must be maintained to document the evaluation, investigation, and any actions taken with respect to nonconforming products.

  • Notification: If nonconforming products have been distributed or could potentially reach users, manufacturers are often required to notify relevant parties, including customers and regulatory authorities, if necessary.

  • Reevaluation: Manufacturers may need to reevaluate and retest nonconforming products if they are reworked or corrected to ensure they meet quality standards before release.

It's important to note that compliance with Nonconforming Product regulations is essential for medical device manufacturers to maintain the integrity of their quality management systems and meet regulatory requirements. Failure to comply with these regulations can result in regulatory actions and sanctions by the FDA.

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