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Catching Fire: FDA's Manufacturing Maturity Program For Devices Spreading Internationally – And To Drug Facilities

 
• By Shawn M. Schmitt

The US agency's Case for Quality Voluntary Improvement Program – used to measure a device-maker's manufacturing maturity and quality – has surprisingly been used to assess some pharmaceutical facilities. Meanwhile, regulators from other countries have been reaching out informally to the FDA to learn more about CFQ VIP.

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A popular-with-industry approach for measuring a device-maker's manufacturing maturity and quality has surprisingly been used to assess some pharmaceutical facilities.

So says Cisco Vicenty, the Case for Quality program manager in the US Food and Drug Administration's Office of Product Evaluation and Quality (OPEQ), within the Center for...

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More from Policy & Regulation

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