Pharmaceutical QMM Model: QMM Assessment to Promote Pharmaceutical Operational Excellence

In recent months, FDA has begun championing Quality Management Maturity (QMM), a new quality surveillance initiative intended to raise awareness at all levels of management in the pharmaceutical industry as to how to best achieve quality objectives and improve manufacturing site quality and supply chain reliability in drug manufacturing processes. QMM follows a maturity modeling paradigm first developed and adopted by other high technology industries. The nexus between a clearly articulated mature quality culture, technical processes, and corporate-wide business practices that are integrated with quality objectives has crystallized into a viable roadmap for enhancing a drug manufacturer’s operations, while satisfying patient needs and corporate goals.

FDA Quality Management Maturity (QMM) Overseas Pilot Program Findings: Going Beyond the Regulations

FDA mentioned QMM in its 2019 report, Drug Shortages: Root Causes and Potential Solutions, which pointed to a lack of manufacturer incentives to improve their quality management beyond the minimum required for current good manufacturing practice (CGMP) compliance. In this podcast learn what QMM is, and how far beyond GMP functions QMM will drill into, and what accountability senior management bears for sustaining a corporate quality management culture, from an interview with executives at Shabas Solutions LLC, who ran the overseas pilot program.


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