About ISPE's Quality Metrics Initiative

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What are Quality Metrics?

Following the passage of the Food and Drug Administration Safety and Innovation Act (FDASIA) of 2012, the FDA was authorized to collect manufacturing quality data from pharmaceutical companies and obtain certain records from a drug manufacturer in lieu of, or in advance of, an inspection. FDA also was directed to replace the previous two-year drug inspectional frequency requirement with a risk-based inspection approach.

The FDA is considering the utilization of quality metrics as an input to its inspection models as well as to predict possible drug shortages, determine inspection schedules for a manufacturer, assess post-market change reporting, and re-structure the format of inspection. To that end, the FDA invited input from industry on which metrics manufacturers use and find effective to assess processes and their risks.

ISPE Leading the Charge to Bring Industry and Regulators Together to Discuss Quality Metrics

Routine company metrics include number of lot release tests, out-of-specification results, and lots attempted, rejected, reworked, and reprocessed. However, each company tends to collect data in its own way for its own internal use, using a range of definitions and sampling plans. How firms measure and define “batch,” “lot,” and even “rejection” can differ among companies in different sectors, in the same sector, and even within the same company. Standardization is needed to ensure that the metrics reported to the FDA are defined and measured the same way by all.

The industry’s first public conversations on quality metrics took place at workshops held during ISPE’s 2nd Annual CGMP Conference in June 2013 and at the ISPE Annual Meeting in November 2013, led by Cindy Salamon, VP, Global Quality Services, Bristol-Myers Squibb and Russell Wesdyk, Science Coordinator, US FDA. An ISPE Quality Metrics Team was convened to distill the conversations to a list of metrics that could be standardized and would be meaningful for predicting the safety, quality, and availability of drugs.

From those robust discussions, ISPE developed a whitepaper proposing an initial list of quality metrics linked to the six systems inspected by FDA. ISPE will launch a pilot program in June 2014 to refine the set of metrics and definitions, data submission process, and evaluation. The pilot will launch with a workshop session at the 3rd Annual ISPE-FDA CGMP Conference in Baltimore.

The ISPE whitepaper and pilot program support FDA efforts to develop guidance on quality metrics. FDA hopes to define initial metrics by the end of 2014, setting the stage for collecting quality metrics from industry in 2015.


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