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ISPE Announces Quality Metrics Pilot Launch
ISPE has announced the launch of a Metrics Pilot Program, which is designed to test industry-consensus metrics and evaluate the feasibility of data collection at drug development companies with different metrics programs.
The pilot, headed by ISPE’s PQLI Quality Metrics Team, is open to any drug manufacturing company that is registered with FDA and is designed to encourage participation from a broad spectrum of technologies and types of companies within the pharmaceutical industry.
"ISPE is committed is to helping industry identify and define the metrics that are truly indicative of quality," said Nancy Berg, ISPE's President and CEO. "Attention to the 'right' metrics can help promote positive behaviors and instill in companies a corporate culture of responsibility for quality. ISPE’s Pilot also will explore the opportunities and challenges associated with how metrics are collected and interpreted, as well as consider possible next steps in metrics implementation."
The ISPE Quality Metrics team was charged with identifying and defining metrics that reflect quality and determining metrics to be applied to sites versus those applied to products. The metrics selected for the pilot were specifically chosen to enable assessment of site, product and quality system performance.
Primary objectives for the pilot’s initial phase are to test harmonization of definitions for industry consensus metrics that represent both leading and lagging indicators; and test the feasibility of data collection across companies who are at different maturity levels with their own internal metrics programs.
Participants will receive blinded comparison among their technology platform peers, as well as a start on establishing internal procedures for metric collection, a set of metric definitions, and insight into implications for metric implementation.
McKinsey & Company is partnering with ISPE on the Pilot and will confidentially manage data collection and analysis.