Voluntary Quality Management Maturity Prototype Assessment Protocol Evaluation Program

https://www.federalregister.gov/documents/2024/01/25/2024-01423/voluntary-quality-management-maturity-prototype-assessment-protocol-evaluation-program?utm_medium=email&utm_source=govdelivery Today, the U.S. Food and Drug Administration is announcing an opportunity for drug manufacturers to participate in the next phase of the development of the Center for Drug Evaluation and Research’s Quality Manufacturing Maturity (QMM) Program. FDA is launching a voluntary QMM Prototype Assessment Protocol Evaluation Program, which involves the use of a prototype assessment protocol, to evaluate an establishment’s QMM. QMM is the extent to which drug manufacturing establishments prioritize patients, drive continual improvement, and enhance supply chain reliability through the strategic integration of business decisions and manufacturing operations with quality practices and technological advancements. The QMM program aims to encourage drug manufacturers to implement quality management practices that go beyond current good manufacturing practice (CGMP) requirements. FDA has developed a prototype assessment protocol to evaluate an establishment’s level of QMM and is seeking the participation of nine firms to evaluate the protocol’s effectiveness. The prototype assessment protocol includes a series of questions in five practice areas: leadership, business continuity, technical excellence, advanced pharmaceutical quality system, and employee empowerment and engagement. The program will allow drug establishments to gain experience with the prototype assessment protocol and allow FDA to evaluate whether use of the protocol, as designed, will enable a meaningful assessment of the establishment’s quality management practices while providing useful feedback for the establishment. The outcomes from this program will help to inform the development of the protocol to be used in the eventual QMM program. Please review the notice for the types of establishments FDA is seeking for participation and the process for submitting a request to participate in the program.