The US Food and Drug Administration (FDA) has received “positive” feedback from stakeholders that participated in its quality metric management maturity (QMM) programs, said an agency official, the results of which will help inform the development of a future rating program.
Michael Kopcha, director of FDA’s Office of Pharmaceutical Quality (OPQ) also told a recent webinar that the public should not confuse quality metrics with QMM. Kopcha and other officials discussed the agency’s recently concluded QMM pilot programs and its approach to QMM at a 25 May webinar sponsored by FDA’s Small Business and Industry Assistance (SBIA) program. FDA’s QMM approach was outlined in a white paper released last month. (RELATED: FDA proposes to rate pharmaceutical manufacturing facilities, Regulatory Focus 7 April 2022)
In the white paper, FDA proposed the development of a rating system to measure a firm’s QMM as a way to mitigate drug shortages and enhance product quality, but came short of offering any specific proposals on how it would work…
