Complete Guide to Quality Management Maturity Program

This guide presents an overview of the FDA’s Quality Management Maturity (QMM) program, which aims to address systemic issues in the pharmaceutical industry related to drug quality and manufacturing practices. It outlines the background of the program, initiated in response to a 2019 drug shortage report, which identified that a significant percentage of shortages were due to suboptimal product and manufacturing quality. The guide details the FDA's three suggestions for improving quality management, including the establishment of a rating system to encourage manufacturers to advance beyond basic compliance with current good manufacturing practices (cGMP). It further explains the new understanding of the pharmaceutical quality system, emphasizing the need for a cohesive approach that integrates quality management into all business operations. The document also discusses methods for measuring quality management maturity and identifies signals of functional quality maturity within pharmaceutical operations. Lastly, it highlights the ongoing consultations and potential future developments of the QMM program both domestically and internationally.