FDA's 2025 QMM Prototype Assessment Program

The U.S. FDA has announced the continuation of its voluntary Quality Management Maturity (QMM) Prototype Assessment Program for 2025. Overseen by the Center for Drug Evaluation and Research (CDER), the initiative evaluates drug manufacturing facilities based on five core areas: leadership commitment to quality, business continuity planning, technical expertise, modern quality systems, and employee involvement. These categories include critical elements such as data governance and continuous improvement. Insights from the 2024 pilot—where nine facilities were assessed—led to protocol revisions, addressing participant feedback about redundancy. Facilities that wish to participate must meet eligibility requirements, including recent FDA inspection results of “No Action Indicated” or “Voluntary Action Indicated,” and active U.S. distribution of at least one CDER-regulated product. The program offers detailed feedback on strengths and improvement areas. Applications are open through June 9, 2025. The goal is to promote robust quality culture and operational resilience across the pharmaceutical industry.

12-05-2025