ISPE to Conduct Quality Metrics Pilot Program with FDA
ISPE will conduct the industry's first Quality Metrics Pilot Program designed to define and operationalize standard metrics reporting to the U.S. Food and Drug Administration (FDA). The year-long program will test a series of leading and lagging indicators that will support an FDA risk-based inspection program in lieu of biennial inspections, as directed by the Food and Drug Administration Safety and Innovation Act (FDASIA).
"ISPE is honored to lead this important initiative, which aligns the perspectives of its extensive global membership network and aids FDA in its strategic goals to ensure a reliable supply of medicines," said Nancy S. Berg, President and CEO of ISPE. "Building on the extensive work conducted by the ISPE Quality Metrics project team and FDA input, this pilot program will provide a practical approach for both industry and regulators to refine metrics selection and definition, and to develop an operational and pragmatic approach to implementation."
Since early 2013, ISPE has been bringing industry and regulators together to identify and define potential metrics by facilitating the first public discussions on quality metrics. From those discussions, ISPE developed a whitepaper that proposed an initial list of quality metrics linked to the six systems inspected by FDA, and recommended a pilot test to refine the set of metrics and definitions, data submission process, and evaluation. FDA recently reviewed ISPE's plans for the pilot program and encouraged the Society's plans.
The pilot will be open to a limited number of sites and product types, e.g., solid orals and sterile, and will represent branded, generic, and over-the-counter products, ensuring statistically meaningful findings. The pilot also will take into account a sampling from large molecule sites to test the feasibility and applicability of data definitions and collection. Companies will be assured of complete data confidentiality. To manage the pilot, ISPE intends to work with a highly-respected global consulting firm that will handle data collection, fact-based research, and analysis. Members of ISPE's PQLI® Team will provide project oversight.
ISPE plans to launch the pilot with open workshops for industry education and input to be held with FDA participation during the 3rd Annual ISPE-FDA CGMP Conference in Baltimore, MD, in early June 2014. Findings of the pilot will be published in the form of papers and educational sessions. Final data and evaluation will be supplied to the FDA and participating companies in aggregate form and will include learnings on feasibility and implementation requirements.