What are the FDA Quality Metrics The Food and Drug Administration Safety and Innovation Act (FDASIA) of 2012 provides the FDA with new authorities to ensure the safety, quality, and availability of the drug supply chain...
Designed and developed by the ISPE Quality Metrics Core Team, the project drew on the knowledge and experience of cross-functional industry representatives, ex-regulators and academicians, with further insight gained in detailed discussions with a variety of industry associations at many industry meetings.
Special Pricing for Emerging Economies ISPE, in cooperation with McKinsey and Company and 21 participating companies, designed and undertook an extensive Pilot Program from 2014 to 2016 to test the feasibility of collecting and reporting a
To further the understanding of opportunities, challenges and benefits of implementing a quality metrics program, ISPE, in cooperation with McKinsey and Company, established the ISPE Quality Metrics Pilot Project in 2013.
ISPE will conduct the industry’s first Quality Metrics Pilot Program. The year-long program will test a series of leading and lagging indicators that could support an FDA risk-based inspection program in lieu of biennial inspections, as directed by...
