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FDA issues final report on its "21 st Century" initiative on the regulation of pharmaceutical manufacturing.

Publication: M2 Presswire
Publication Date: 30-SEP-04 		Format: Online - approximately 1017 words
Delivery: Immediate Online Access

Article Excerpt
M2 PRESSWIRE-30 September 2004-US FDA: FDA issues final report on its "21 st Century" initiative on the regulation of pharmaceutical manufacturing(C)1994-2004 M2 COMMUNICATIONS LTD

RDATE:09292004

Following the second anniversary of the launch of its Pharmaceutical Manufacturing Initiative, the Food and Drug Administration (FDA) today issued a final report that highlights specific steps the agency has taken and will take to develop and implement quality systems management and a risk-based product quality regulatory system.

The report describes the accomplishments and plans for the future resulting from FDA's completed assessment of the current good manufacturing practice (CGMP) regulations, current practices, and the new tools in manufacturing science that will enable a progression to controls based on quality systems and risk management.

"Americans must have confidence in the quality of their medications even as we face more sophisticated technology and manufacturing processes," HHS Secretary Thompson said. "This final report provides clear guidance for both...

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