QMM Protocol Volunteers Sought

FDA is seeking nine drug companies to volunteer to test its new Quality Manufacturing Maturity (QMM) Prototype Assessment Protocol Evaluation Program, the next phase in CDER’s QMM program. A Federal Register announcement says the protocol is used to evaluate an establishment’s level of QMM. It includes a series of questions covering leadership, business continuity, technical excellence, advanced pharmaceutical quality system, and employee empowerment and engagement.

FDA says the program will allow drug establishments to gain experience with the prototype assessment protocol and permit the agency to evaluate whether using it as designed will enable a meaningful assessment of the establishment’s quality management practices, while providing useful feedback for the establishment.

The notice describes the types of establishments FDA is seeking for participation and the process for submitting a request to participate in the program.