ISPE has been leading the charge to bring industry and regulators together to discuss quality metrics ever since the US FDA first brought the subject to the forefront of industry thinking in the Food and Drug Administration Safety and Innovation Act (FDASIA).
20 December 2013: ISPE Proposals for FDA Quality Metrics Program – Whitepaper
At the request of FDA, the ISPE Quality Metrics working group has developed a whitepaper on potential measures of product quality, site operations quality and site systems performance. The recommendations contained in the paper stem from robust industry - FDA discussions facilitated by ISPE’s Quality Metrics working group.
6 December 2013: Status Report Released
The ISPE Quality Metrics working group has released a status report detailing an initial list of quality metrics considered acceptable to industry as a starting point. These metrics would be reportable to FDA to support a risk-based inspection program as called for in sections 704 to 706 of FDASIA, and should assist industry in moving towards the 'desired state.'
FDASIA allows the FDA to collect information that would be available on inspection “in advance or in lieu of an inspection” and requires the FDA to do risk-based inspections. Quality metrics are a type of information that could be provided in advance of an inspection. The FDA is seeking broad input and listening to the industry on this topic
The industry’s first public conversations on quality metrics took place at ISPE’s CGMP Conference in June 2013 during a workshop-style session led by Cindy Salamon, VP, Global Quality Services, Bristol-Myers Squibb and Russell Wesdyk, Science Coordinator, US FDA. The conversations continued at a capacity-attendance session at the ISPE Annual Meeting in November 2013, again led by Salamon, with Wesdyk returning to present an update on the FDA’s perspective, and attended by other FDA regulators. Ideas exchanged at these sessions are being incorporated by the working group into an ISPE white paper to be presented to FDA later in December.
Please send any feedback to PQLI@ispe.org.