Quality metrics are utilized throughout the pharmaceutical industry to monitor quality control systems and processes and to drive continuous improvement efforts in drug development and manufacturing. The U.S. Food and Drug Administration, through a recently-published draft guidance and its corresponding Federal Register notice, is making good on its decade-old promise to create a system in which pharmaceutical manufacturers consistently and reliably produce “high-quality drug products without extensive regulatory oversight.” This guidance offers transparency to industry by painting a clear picture of what the agency is thinking with regard to the use of certain quality metrics for risk-based oversight. Entities that work to internalize this guidance and produce timely, thoughtful reports to the agency that demonstrate highly controlled manufacturing and a robust quality measurement system should see positive results: less frequent agency inspections and greater ability to self-regulate.
The guidance, entitled Request for Quality Metrics, and the forthcoming corresponding public meeting are intended to explain how the agency plans to use quality metrics data to further develop its risk-based inspection scheduling, to identify situations in which there may be a risk for drug supply disruption, to improve efficiency and effectiveness of establishment inspections and to improve the FDA’s evaluation of drug manufacturing and control operations.
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