Quality Metrics: Finding a Common Ground Between FDA and Industry
According the CDER’s Russell Wesdyk’s presentation on Quality Metrics, the FDA’s vision for 21st Century manufacturing is “a maximally efficient, agile, flexible pharmaceutical manufacturing sector that reliably produces high quality drugs without extensive regulatory oversight.”
The current buzz around the pharmaceutical manufacturing community focuses on finding a shared vision with the FDA in defining quality metrics that apply across all sectors (Generic, Rx, OTC) and are not labor intensive for regulatory agencies and industry.
While the FDA’s guidance is still in development, both industry and regulatory representatives agree, an effective and efficient Quality Metrics reporting program is vital. The program must support robust quality systems, product development, risk management, ensuring patient safety and avoiding drug shortages.
Building upon this ongoing conversation, ISPE launched Wave 1 of the Quality Metrics Pilot Program in 2014, which provided the industry’s first real world experience with metrics definitions, data collection and assessed the reporting burden.
With tangible data as the leading indicator of the ISPE Quality Metrics Pilot Program, the society will readout the preliminary data and findings from the participating 18 companies and 44 sites at the ISPE Quality Metrics Summit on 21 – 22 April 2015, in Baltimore, MD.
Definitions of the society’s proposed qualitative and quantitative metric set, such as 14 measures reflecting a mix of leading and lagging indicators collected by site and product collected, is designed to aid in understanding what metrics and definitions lead to the most uniform interpretations, least “gaming” and best quality practices.
Summit attendees will be able to provide input to the FDA through open and constructive dialog on the proposed metrics before the report is finalized. Attendees will also receive an advance copy of the final ISPE Quality Metrics Pilot Program report before it’s available to the general public.
This comprehensive and timely forum serves as the most to discuss real data and measures of product quality, site operations quality and site systems performance according to developing FDA quality metrics guidelines. For more information on the ISPE Quality Metrics Summit or to register, please visit www.ISPE.org/2015-Quality-Metrics-Summit.