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FDA recently announced an opportunity for a limited number of drug manufacturing establishments to participate in the second year of the voluntary Quality Management Maturity Prototype Assessment Protocol Evaluation Program, which involves use of a refined prototype assessment protocol to evaluate quality management maturity (QMM). The Center of Drug Evaluation and Research (CDER) implemented this voluntary program for manufacturers of CDER-regulated drug products to gain additional experience with the prototype assessment protocol and process, to help enable consistent and meaningful assessment of participating establishments’ quality management practices, and to provide useful feedback to participants.
Using feedback received and insights gained from the 2024 program, CDER modified its 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 2025. 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 June 9, 2025.
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