USFDA Announces Second Quality Management Maturity Assessment Program

USFDA has announced the Quality Management Maturity (QMM) Prototype Assessment Protocol Evaluation Program for the second year. It provides opportunity for a limited number of drug manufacturers to participate in the programme to evaluate Quality Management Maturity. CDER will accept requests to participate in the voluntary QMM Prototype Assessment Protocol Evaluation Program through June 9, 2025.

This year the FDA will use of a refined prototype assessment protocol based on the feedback from participants and CDERs experience and insights gained in the 2024 QMM evaluation programme. The 2024 QMM assessment program involved a series of questions in five practice areas:

• management commitment to quality
• business continuity,
• technical excellence,
• advanced pharmaceutical quality system, and
• employee empowerment and engagement

and included topics like management review, resource management, supply planning and demand forecasting, continual improvement, data governance and process optimization, employee rewards and recognition.

CDER will select participants for the programme that reflect the diversity of the industry. The programme will involve a virtual orientation session, a pre-assessment questionnaire and assessment involving three assessors. Following the assessment each participating establishment will receive a report with their score, narrative, areas of strength and opportunities for improvement. In the post assessment phase, participating establishment will be encouraged to select at least one opportunity to improve from the QMM report and develop an improvement plan with a defined goal. CDER will meet with participating establishment to discuss progress made toward achieving the improvement goal in about six months from the QMM report.

Drug product (including OTC) and API manufacturers who has received at least one human drug establishment inspection with current inspection classification status of NAI (No Action Indicated or VAI (Voluntary Action Indicated) and willing to participate in an onsite or hybrid assessment can request to participate in the voluntary QMM Evaluation Program.

FDA Notice: Voluntary Quality Management Maturity Prototype Assessment Protocol Evaluation Program (23 April 2025)