FDA recently announced an opportunity for a limited number of drug manufacturing establishments to participate in the third year of the voluntary Quality Management Maturity Prototype Assessment Protocol Evaluation Program, which involves use of a refined prototype assessment protocol to evaluate a drug manufacturing establishment’s level of quality management maturity (QMM). The Center of Drug Evaluation and Research (CDER) implemented this voluntary program to gain further experience with the assessment tool and further refine it as necessary, expand knowledge of quality management practices in the industry, and provide additional drug manufacturing establishments with actionable feedback. This will help ensure that the assessments enable consistent and meaningful evaluations of establishments’ quality management practices.

CDER used feedback received and insights gained from completed QMM assessments to modify the prototype QMM assessment tool to be clearer and more concise. We also updated the rubric and clarified some of the questions. CDER intends to evaluate these improvements and further refine the prototype protocol as necessary by continuing the program with establishments that wish to volunteer to participate in 2026. This notice announces CDER’s intent to continue the voluntary QMM Prototype Assessment Protocol Evaluation Program, outlines the types of establishments CDER is seeking for participation, and describes the process for submitting a request to participate in the program.

FDA will accept requests to participate through April 13, 2026. [FDA]