FDA issues white paper on prototype assessment protocol for Quality Management Maturity program

FDA issues white paper on prototype assessment protocol for Quality Management Maturity program https://www.fda.gov/media/171705/download?attachment=&utm_medium=email&utm_source=govdelivery FDA’s Center for Drug Evaluation and Research (CDER) is establishing a program to promote quality management maturity (QMM) at drug manufacturing establishments. CDER has issued a new white paper describing the prototype assessment protocol the agency has been developing to assess an establishment’s level of QMM. The prototype assessment protocol includes a structured, objective approach to evaluate an establishment’s level of maturity in five practice areas: Management Commitment to Quality Business Continuity Advanced Pharmaceutical Quality System Technical Excellence Employee Engagement and Empowerment This new white paper provides a high-level overview of each practice area and examples of topics that may be covered within them. CDER’s next step in implementing a QMM program is to apply this protocol to establishments in the next year and refine it based on initial experience. In the coming weeks, the agency intends to gather public input to assist in the development of the QMM program Following the Pharmaceutical Science and Clinical Pharmacology Advisory Committee meeting in November 2022, CDER committed to sharing information about the QMM program. For more information on the QMM program history, the prototype assessment protocol, and misconceptions about the QMM program please read the white paper.