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FDA News

FOR IMMEDIATE RELEASE
P04-93
September 29, 2004

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FDA Issues Final Report on Its “21 st Century” Initiative on the Regulation of Pharmaceutical Manufacturing

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 FDA and manufacturers to implement a risk-based quality assessment system that will ensure that the drug supply in the United States is of consistently high quality.”

“The accomplishments and next steps announced demonstrate FDA’s commitment and continued progress toward modernizing the regulation of manufacturing and product quality for both human and veterinary drugs as well as biological products,” said FDA Acting Commissioner Dr. Lester M. Crawford. “FDA’s CGMP Steering Committee has completed its two-year assessment of existing CGMP programs, and the agency has begun to implement a new scientific and risk-based approach to pharmaceutical manufacturing and product quality.”

FDA’s initiative has focused on its current regulation of pharmaceutical quality, encompassing veterinary and human drugs, and select human biological drug products such as vaccines. The report issued today addresses FDA’s findings, which put the agency on a path to develop the product quality regulatory system of the future. The report describes specific steps the agency is taking to achieve this system. Some of these include:

In addition, the following accomplishments underscore the agency’s commitment to realizing the specific goals of this initiative:

Making improvements in the way we regulate pharmaceutical manufacturing and product quality is necessary to require the use of the best scientific data available, to develop quality standards, and to use efficient systems and practices that will provide clear and consistent decisions and communications for the regulated industry and the American public.

The progress that is being made reflects the agency’s commitment to the consistent adoption of risk management principles and a strong, robust inspection and enforcement program centered on the protection of the public health of all Americans.

More information on this major initiative, as well as the final report, is available online at http://www.fda.gov/cder/gmp/gmp2004/GMP_finalreport2004.htm

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