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Overcoming Fear of ‘CPV Monster,’ Drug Makers Launch Continued Process Verification Programs

 
• By Bowman Cox

Most pharmaceutical manufacturers are adopting or making plans to adopt the continued process verification approach outlined in FDA’s November 2011 process validation guidance, which will shine a light on their manufacturing processes. But not everyone is anxious to see what that light will reveal.

Most pharmaceutical manufacturers have begun adopting the continued process verification concept that FDA outlined in its January 2011 process validation guidance, but progress has been slowed by the sheer magnitude of the project.

There are some that have not started on their CPV adoption projects, either for fear of what one consultant calls “the CPV monster,” or perhaps out of recognition that FDA...

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The budget authority total, which is significantly higher than the amount floated in an April OMB draft document, suggests there may have been successful lobbying to increase FDA funding.

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• By Bridget Silverman

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