US FDA’s ‘Mature’ Approach To Quality: ‘Encourage More, Punish Less’
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.
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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.
High ratings could strengthen company financial performance, agency suggests. But stakeholders would need to understand the difference between site QMM and product quality for the incentives to work properly. More details to follow in upcoming workshop.
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.