FDA's Kopcha Says New Inspection Protocols May Never Be Disclosed
Head of US FDA's Office of Pharmaceutical Quality says agency doesn't want pharmaceutical companies to know just how they will be inspected under the emerging standardized 'NIPP' approach, lest they use that knowledge to game the process.
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The US FDA announces plans to expand its new protocol-based approach to inspections, NIPP, to non-sterile drugs and provides glimpse of what metrics the agency is using to measure pharmaceutical quality during inspections.
US FDA expects the New Inspection Protocol Project (NIPP) it launched Nov. 9 to increase the consistency of its sterile manufacturing inspections – and the ability of those inspections to catch quality problems before they could lead to drug shortages.
The head of US FDA's drug quality office, Michael Kopcha, rebukes industry pushback that got White House's ear and demands more constructive feedback on quality metrics. Industry workshop participants come up with creative ideas, but FDA finds them problematic. Asked whether industry should dive in or wait and see on voluntary phase of metrics initiative that begins in January, another FDA official says, "That's a tough one."