CDER Continues Quality Management Program

Federal Register notice: FDA is seeking a limited number of drug manufacturing establishments to participate in the second year of its voluntary Quality Management Maturity Prototype Assessment Protocol Evaluation Program and its use of a refined prototype assessment protocol to evaluate quality management maturity (QMM). The voluntary program was developed to gain additional experience with the prototype assessment protocol and process, which FDA says is intended to help enable consistent and meaningful assessment of participating establishments’ quality management practices, and to provide useful feedback to participants. In 2023, CDER published a white paper, “CDER’s Quality Management Maturity Program: Practice Areas and Prototype Assessment Protocol Development,” which discusses the assessment approach planned to be used at establishments participating in the QMM program. To view the notice, click here.