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Quality Metrics Industry Pilot: A Progress Report from ISPE

Hagerty D.

Respiratory Drug Delivery 2016. Volume 1, 2016: 223-228.

Abstract:

The Food and Drug Administration (FDA) Quality Metrics initiative is a product of the Food FDA Safety and Innovation Act (FDASIA) intended to encourage pharmaceutical companies to implement a modern, risk-based pharmaceutical quality assessment and risk-based inspection system, and additionally, to potentially mitigate drug shortages. The International Society for Pharmaceutical Engineering (ISPE) has been instrumental in bringing industry and regulators together to gather clear and objective data through its Quality Metrics Pilot Program. This presentation will discuss the FDA’s Quality Metrics program timeline and provide an overview of the findings from ISPE’s Quality Metrics Pilot Program for Wave 1, which reported in June 2015, and the design of, and participation in, Wave 2, which is scheduled to be reported in June 2016. ISPE’s response to the FDA Draft Guidance detailing how the FDA plans to use quality metrics to improve its ability to conduct risk-based inspections and predict or mitigate potential drug shortages will be summarized. Finally, future thinking relating to quality metrics such as providing material, tools, and training to assist companies and individuals progress their quality culture or excellence programs, and potentially to the development of collaborations to support industry quality metrics programs additional to that requested by the FDA will be described.