FDA Releases White Paper and Announces Two Workshops on Quality Management Maturity - Drug Information Update

U.S. Food and Drug Administration sent this bulletin at 04/07/2022 09:10 AM EDT

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FDA Center for Drug Evaluation and Research Division of Drug Information

FDA Releases White Paper and Announces Two Workshops on Quality Management Maturity

FDA’s Office of Pharmaceutical Quality (OPQ) in the Center for Drug Evaluation and Research (CDER) released a white paper titled “Quality Management Maturity: Essential for Stable U.S. Supply Chains of Quality Pharmaceuticals.” CDER also opened the registration for two stakeholder workshops on quality management maturity (QMM) on May 24th and 25th, 2022. Quality management maturity is the state attained when drug manufacturers have consistent, reliable, and robust business processes to achieve quality objectives and promote continual improvement. Mature quality management ensures quality products are on the market now, and that quality issues will not cause shortages for patients and consumers in the future.

View the white paper

Register for the workshops

CDER is developing a QMM program to increase transparency and incentivize mature quality management practices by pharmaceutical manufacturers. A QMM program could inform regulators and purchasers about the performance and robustness of drug manufacturing facilities and give patients increased confidence in the availability of their drugs. OPQ’s white paper explains the need for a QMM program and based on stakeholder engagement, shares some key challenges to developing a program and key elements of a successful program.

CDER’s Small Business and Industry Assistance will host two QMM workshops to further stakeholder engagement on QMM. The first workshop will cover CDER’s QMM program, and the second will discuss the development and impact of quality ratings. Both workshops will include speakers and panelists from outside of FDA to discuss QMM. Since nearly everyone is a stakeholder in the pharmaceutical supply chain, CDER invites pharmaceutical purchasers, distributors, wholesalers, manufacturers, international regulators, experts on quality management systems, government agencies involved in pharmaceutical the supply chain, payors, and benefits managers to attend these workshops.

For additional information please visit CDER’s quality management maturity webpage.