Author: Kamal Biswas

Nine drug manufacturers. All inspection-cleared. Quality maturity scores from 2.4 to 4.6. In April, FDA’s Center for Drug Evaluation and Research (CDER) shared the first public scorecard from its Quality Management Maturity (QMM) Prototype Assessment Program. The data is worth a careful look. It is also, I think, more revealing than most early commentary has…

What QMM is, Implications for Patients and Public Health By Kamal Biswas  ·  Regller What Is Quality Management Maturity? Quality Management Maturity, or QMM, describes how well an organization’s quality system actually functions over time — not whether it meets the minimum required, but how reliably, intelligently, and sustainably it produces quality outcomes. Maturity is…