Quality Metrics – New Guidance from FDA

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Quality metrics are used throughout our industry to drive continuous improvement efforts in manufacturing. Collecting the right quality metrics is critical to ensure compliance. Quality metrics can also help the FDA in developing compliance and inspection policies and procedures by allowing the FDA to:

  • Use a risk-based inspection scheduling of drug manufacturers
  • Improve ability to predict and possibly mitigate future drug shortages
  • Encourage the pharmaceutical industry to implement state-of-the-art, innovative quality management systems for manufacturing.

The revised draft guidance includes an explanation of how the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) intend to utilize submitted data and quality metrics to help ensure that their policies and practices continue to support continuous improvement and innovation.

FDA is initiating a voluntary reporting phase of the FDA quality metrics reporting program where they expect to learn more about a limited set of quality metrics, associated analytics, and improve the FDA quality metrics reporting program.

During the voluntary phase of the reporting program, FDA will accept voluntary submissions of data from drug manufacturing firms involved in the manufacture, preparation, propagation, compounding, or processing of finished dosage forms (FDF) or active pharmaceutical ingredients (API) used in the manufacture of “covered drug products.”

For more information and to download the guidance, click here.