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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