As those of you who attended the successful workshop at the second annual CGMP Conference in June or read Chris Potter’s recent article for Pharmaceutical Engineering know, ISPE has been leading the charge to bring industry and regulators together to discuss quality metrics ever since FDASIA first brought the subject to the forefront of industry thinking. Here some key takeaways that have come out of the discussion to-date:
- 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.
- According FDA OSP Science Coordinator Russ Wesdyk’s presentation at the 2013 ISPE-FDA CGMP Conference, the FDA’s ideals for quality metric criteria are that they meet FDASIA sections 706 and 704; are relevant; avoid unintended consequences; are objective and quantitative; are applicable across sectors of the industry; are not excessively intrusive to industry and easily operationalized by the FDA; and are understandable.
- The FDA is seeking broad input and listening to the industry on this topic, via meetings such as the 2013 ISPE-FDA CGMP Conference in Baltimore and the 2013 ISPE Annual Meeting.
- Based on the feedback from the Quality Metrics workshop at the CGMP Conference, the ISPE Quality Metrics working group has decided to work in the areas of Out of Specification/Laboratory Failure Investigation Rates, Batch Failure Rates and leading metrics/new ideas (including the six Quality Systems the FDA uses when preparing for an inspection).
- The Quality Metrics working group will present suggested metrics acceptable to the industry in the areas of OOS/Laboratory Failure Investigation Rates and Batch Failure Rates on Monday, 4 November during the Quality Metrics Executive Session at the 2013 ISPE Annual Meeting.
The overall goal of the ISPE Quality Metrics Project is to produce a white paper acceptable to industry on quality metrics, which could be reportable to the FDA to support a risk-based inspections program as included in FDASIA. The conversations and feedback from the Annual Meeting session will factor heavily into the white paper the group produces. We hope you’ll join us to be a part of this important industry discussion.