Quality Metrics
A selection of articles and news about quality metrics.
Large Industry Cross-Section Contributes to PDA Quality Metrics Recommendations
PDA works with FDA to create pharmaceutical quality metrics.
Linking Drug Shortages and Quality Metrics
Industry players offer suggestions for quality metrics as FDA continues to try and solve the problem of drug shortages.
Metrics Sought to Ensure Drug Quality
Regulators work with manufacturers to improve systems for measuring product performance and manufacturing reliability.
PDA Panel Proposes Limited Set of Metrics to Measure Quality Trends
PharmTech Talk
January 28, 2014
By: Jill Wechsler
Industry Needs to Drive the Dialogue Regarding FDA’s Quality Metrics Initiative
October 24, 2013 PharmTech Talk
Guest blog written by Walter Morris, Director of Publishing, Parenteral Drug Association, on behalf of the PDA Quality Metrics Task Force.
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A Novel, Enhanced, and Sustainable Approach to Audit Trail Review
July 4th 2025Eli Lilly and Company developed an innovative and sustainable approach to audit trail review (ATR) aimed at reducing the ATR burden while adhering to regulatory expectations and data integrity (DI) principles. The process has transformed employees' understanding of ATR and complemented the DI by design approach, leading to better system designs that meet expected controls and reduce non-value-added data reviews.
