FDA is extending its Quality Management Maturity Programme

The U.S. Food and Drug Administration (FDA) has announced the continuation of its voluntary Quality Management Maturity (QMM) Prototype Assessment Protocol Evaluation Program for 2025. This initiative, led by the Center for Drug Evaluation and Research (CDER), aims to further refine the assessment of quality management practices within drug manufacturing establishments. 

Building upon insights from previous pilot programs, the 2025 iteration introduces a streamlined assessment protocol. The evaluation focuses on five key practice areas:

• management commitment to quality
• business continuity
• technical excellence
• advanced pharmaceutical quality systems
• employee empowerment and engagement.

These areas encompass critical elements such as supply planning, data governance, and continual improvement processes.

In 2024, CDER assessed nine establishments using the prototype protocol, providing participants with detailed reports highlighting strengths and areas for improvement. Feedback indicated that while the assessments were valuable, certain aspects were repetitive, prompting refinements in the current protocol. 

Drug manufacturing establishments interested in participating must meet specific criteria, including a history of FDA inspections with classifications of "No Action Indicated" or "Voluntary Action Indicated," and the manufacture of at least one CDER-regulated drug product currently in commercial distribution in the U.S. Applications are open until June 9, 2025.