Submission of Quality Metrics Data Guidance for Industry November 2016

GUIDANCE DOCUMENT

• Docket Number: FDA-2015-D-2537
• Issued by: Center for Drug Evaluation and Research; Center for Biologics Evaluation and Research

Quality metrics are used throughout the drugs and biologics industry to monitor quality control systems and processes and drive continuous improvement efforts in drug manufacturing. These metrics can also be useful to FDA: to help develop compliance and inspection policies and practices, such as risk-based inspection scheduling of drug manufacturers; to improve the Agency’s ability to predict, and therefore, possibly mitigate, future drug shortages; and to encourage the pharmaceutical industry to implement state-of-the-art, innovative quality management systems for pharmaceutical manufacturing. This revised draft guidance includes an explanation of how the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) intend to utilize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 26 innovation in the pharmaceutical manufacturing industry

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All written comments should be identified with this document's docket number: FDA-2015-D-2537.