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US FDA Launches Quality Maturity Pilot Program That Rewards High-Performing Manufacturers

 
• By Joanne S. Eglovitch

High ratings on factors like quality culture could yield post-approval change flexibility for participating drug product and API manufacturing facilities.

Happy Panel Judges Sitting In Front Of Red Curtain Showing 10 Score Signs
how mature is your quality management? • Source: Shutterstock

The US Food and Drug Administration is looking for manufacturers to participate in two quality management maturity (QMM) pilots where facilities would be rated and assigned a score as part of the agency’s effort to realign its quality metrics program to one that stresses quality management maturity.

As an incentive to participate, those companies assigned high scores will be

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