Get Full Government Meeting Transcripts, Videos, & Alerts Forever!
Get email alerts on the Qmm Overview topic
No spam. Unsubscribe anytime.
Agency official outlines FDAs Quality Management Maturity program to boost drug-supply resiliency
Summary
An agency official described the FDAs Quality Management Maturity (QMM) prototype assessment program as an effort to move industry beyond basic compliance by scoring manufacturers across five practice areas and sharing actionable reports to strengthen supply-chain resilience.
An agency official presented the Quality Management Maturity (QMM) prototype assessment program as a tool to encourage drug manufacturers to adopt quality practices that go beyond minimum regulatory requirements. The presenter said the effort was created to address persistent supply-chain vulnerabilities that contributed to drug shortages, citing a multi-agency 2019 report and COVID-19 disruptions as motivating factors.
"Compliance alone is no longer sufficient to ensure a resilient and a reliable pharmaceutical supply chain," the agency official said, explaining why the program measures establishments across five practice areas. The official described the QMM tool as a protocol of questions and a five-level rubric used to score maturity from "level 1" (lowest) to "level 5" (highest).
The official said the program aims both to recognize establishments with advanced quality-management practices and to identify opportunities for improvement where firms have gaps. Participating establishments receive numerical scores, narrative findings, and a post-assessment process to set measurable improvement goals and report progress to the QMM team.
