Drug Shortage Plan Would Grade Firms To Encourage High-Quality Production
US FDA task force recommends a rating system that purchasers could rely on to reward manufacturers with robust management systems.
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High ratings could strengthen company financial performance, agency suggests. But stakeholders would need to understand the difference between site QMM and product quality for the incentives to work properly. More details to follow in upcoming workshop.
One pilot target domestic manufacturers of finished drugs and another foreign manufacturers of APIs. As an incentive to participate, companies assigned high scores will be accorded regulatory flexibility. Also, participants that disclose facility ratings could “benefit from a competitive advantage.”
High ratings on factors like quality culture could yield post-approval change flexibility for participating drug product and API manufacturing facilities.