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  1. Pharmaceutical Quality Resources

Quality Metrics for Drug Manufacturing

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What are Quality Metrics?

Quality metrics are used throughout the drugs and biologics industry to monitor quality control systems and processes. Modern manufacturing includes robust quality metrics programs as a foundation for continual improvement of product and process quality. Quality metrics are one element of companies’ commitment to quality culture.

Why are Quality Metrics Important?

The Pharmaceutical Quality System (PQS), a management system to direct and control a pharmaceutical company with regard to quality, provides key elements of assurance and oversight necessary for pharmaceutical manufacturing and quality control laboratory processes throughout the entire product lifecycle, from development through commercial manufacturing. It ensures that quality drugs are available when patients need them.

Learn More about FDA’s collaboration with St. Gallen’s University to promote excellence through quality metrics and quality culture.

We have observed examples and also have data which demonstrates that by adopting a quality measurement program, companies improve their overall quality systems. We have also observed early adopters who have integrated robust quality measurement programs in their good business practices with the goal of operational excellence, and ultimately, improved product quality. Since 2016, FDA has been working on a collaborative research project with St. Gallen University to study relevant data-based performance metrics which may be useful in predicting risks to quality prior to failure.

Quality metrics also:

  • Help the FDA develop compliance and inspection policies and practices, and inform risk-based scheduling of drug manufacturing facilities, which can result in a decrease in inspection frequency for high performers.
  • Improve the Agency’s ability to predict, and therefore, possibly mitigate, future drug shortages
  • Provide additional intelligence to inform FDA’s comprehensive surveillance program
  • Encourage implementation of state-of-the-art, innovative quality management systems for pharmaceutical manufacturing
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