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 will begin work on operationalizing a Quality Management Maturity rating system following a public vote of confidence from its outside advisory committee. There are plenty of key details still to be worked out.
Especially if the program eventually will be made mandatory, the US FDA must engage more with drug industry representatives – including OTC – as its plan for quality metric reporting continues taking shape, the trade association says.
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.