FDA describes Quality Management Maturity (QMM) as the state attained when drug manufacturers have consistent, reliable, and robust business processes to achieve quality objectives and promote continual improvement.
FDA has promoted this concept for them to better apply their resources toward inspecting and monitoring GMP manufacturers that may have a higher risk of failures that could lead to product recalls and shortages.
Many manufacturers face the challenge of implementing the appropriate quality management and monitoring systems to ensure that their GMP business processes are consistent, reliable, and robust and can reduce the likelihood of product failure.
Watch this recording to learn about QMM and the FDA’s expectations on assessing the maturity of your Quality Management System based on objective metrics, as described by the FDA in their guidance, presentations, and workshops.