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FDA's Kopcha Says New Inspection Protocols May Never Be Disclosed

 
• By Bowman Cox

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.

Swabbing of glove box
FDA investigators swab glovebox during a recent pharmacy inspection • Source: US Justice Department

US FDA's New Inspection Protocols Project is one of his two top priorities, but Michael Kopcha, director of the agency's Office of Pharmaceutical Quality, doesn't want to say much about it.

Kopcha had a lot to say last month about his other top priority, quality metrics, at a manufacturing quality conference...

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