US FDA Opens Next Round Of Quality Metrics Debate With New Menu Of Options
Based on industry feedback from pilot programs, agency proposes for discussion a layered approach to quality metrics reporting that industry sectors and individual manufacturing facilities could tailor to their needs.
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The US FDA commissioner’s call for the agency or someone else to watch supply chains and anticipate problems sounds a lot like a generics industry idea from 2011.
Proposed ‘Quality Management Maturity’ rating system would be a way to be more ‘proactive and rewarding’ rather than ‘punitive’ when it comes to oversight of pharmaceutical manufacturing. The initiative is clearly important to the head of FDA’s drug quality office.
FDA’s quality metrics initiative emerges from hibernation with a two-part feedback program and a site visit program. The agency plans to collect feedback on quality metrics in certain meetings conducted during the application process – and in a pilot program. Agency staff also plan to visit firms to learn how they use quality metrics.