Quality Metrics

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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...
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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.
iSpeak Blog
ISPE President and CEO John Bournas welcomed attendees and thanked both the companies participating in Wave 1 of the ISPE Quality Metrics Pilot Program for their expertise and enthusiasm and the ISPE Quality Metrics Task Force for their hard work. “It...
iSpeak Blog
As members of ISPE, we are fortunate to have leaders who had the foresight to sponsor Quality Metrics Pilot programs which continue to provide a rich framework for objective data-driven discussions. One such discussion took place on 1 August 2017 when a...
Guidance Docs
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
Guidance Docs
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.
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23 April 2014
News & Press Releases
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...
iSpeak Blog
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...