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FDA Aims for State of Quality with New Inspection Protocol Project

 
• By Bowman Cox

How will FDA investigators advance from today’s highly variable ‘traffic ticket’ inspection approach to tomorrow’s super consistent, semi-quantitative ‘state of quality’ assessments? The answer: A new inspection protocol project that FDA officials have been describing at recent conferences.

A new inspection protocol project FDA officials have been discussing at recent conferences could help the agency discern differences in the state of quality among pharmaceutical manufacturing facilities and reward the better ones with reduced oversight.

The project, a collaboration between the agency’s Center for Drug Evaluation and Research and its field organization, the Office of...

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