The Veeva LearnGxP Podcast The Veeva LearnGxP Podcast

In this episode, we uncover the origins of the FDA's Quality Management Maturity (QMM) program, born from a 2019 task force report on supply chain disruptions. With 62% of drug shortages linked to manufacturing and quality issues, and hospitals facing over $350 million in annual costs, the urgency for QMM is clear. We explore how QMM not only offers significant cost savings but also enhances patient care. Dive into the FDA's three-step approach, from CGMP compliance to ICH Q10, and its four core elements. Despite these benefits, why is the industry hesitant to advance its quality systems? We examine the market dynamics and economic pressures behind this reluctance and the critical need for regulatory intervention. Join us to discover QMM's transformative potential and its profound impact on the future of the pharmaceutical industry.