To further encourage pharmaceutical companies to invest in the reliable production of higher quality products, FDA is reviving efforts to establish a Quality Management Maturity (QMM) program. An updated version of this approach is spelled out in a new White Paper from the Office of Pharmaceutical Quality (OPQ) in the Center for Drug Evaluation and Research (CDER) and will be addressed further at two workshops in May 2022.
QMM encourages drug and biotech firms to develop manufacturing systems and measures that indicate the quality performance of production and marketing systems in ways to avoid drug shortages.
