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August 21, 2002
TO: FDA Employees-Agency-Wide
FROM: Deputy Commissioner, Food and Drug Administration
SUBJECT: Pharmaceutical cGMPs Initiative
FDA announced today that the Agency will be undertaking a significant new initiative concerning the regulation of pharmaceutical manufacturing and product quality. The initiative, Pharmaceutical cGMPs for the 21st Century: A Risk-Based Approach, is described in more detail in the attachment. This initiative will cover veterinary drugs and human drugs, including biological drug products. (References to “drugs” and “pharmaceuticals" are intended to refer to these products).
More than 40 years ago, Congress required that all drugs must be produced in accordance with current Good Manufacturing Practice (cGMP). This requirement was intended to address significant concerns about substandard drug manufacturing practices by applying quality assurance and control principles to drug manufacturing. The last comprehensive revisions to the regulations implementing cGMP requirements occurred almost 25 years ago. In addition, pre-market approval requirements, pertaining to chemistry and manufacturing controls, have also been in effect for many years to ensure quality manufacturing of approved drugs. The cGMP and pre-approval programs have been extremely successful, and pharmaceuticals produced for American consumers are recognized as the world’s gold standard for safety and effectiveness.
Now, as we approach the 25th anniversary of the last major revisions to the drug cGMP regulations, it is time to step back and evaluate the currency of both the cGMP program and the pre-market review of chemistry and manufacturing issues. The initiative announced today is intended to build on the many successes of these two programs and help them continue to be successful in the future by keeping pace with advances in pharmaceutical science and manufacturing technologies.
As described in the attached concept paper, the initiative seeks to integrate quality systems and risk management approaches into the existing programs and encourages adoption of modern and innovative manufacturing technology. The initiative is also intended to enhance the integration of the pre-approval review and cGMP programs and achieve more consistent application across agency organizational components. In addition, the initiative will use existing and emerging science and analysis to ensure that limited resources are best targeted to address important quality issues, especially those associated with predicted or identifiable health risks.
There will be many exciting opportunities for FDA staff to assist in the development, application, and implementation of the new initiative. There will be an emphasis on enhanced coordination of field and headquarters staff, ORA and Center staffs, and harmonizing approaches across Centers. I expect there will be increased opportunities for training, specialization, advancement, and a greater sense of accomplishment associated with a program that will achieve even better results for the American public.
I recognize that this initiative, like all change, will be greeted cautiously by some FDA staff, and this is understandable. First, you should know that the Steering Committee that developed the initiative, and that will be in charge of its implementation, has representatives from all of the affected organizational components, including ORA, CDER, CBER, CVM, and OC. Second, this is a long-term, science-driven process that will take time to develop and implement. Third, this initiative will strengthen the public health protection achieved by FDA’s regulation of pharmaceutical manufacturing. FDA remains committed to strong enforcement of the existing regulatory requirements, even as we are examining and revising our approach to these programs.
Information on this initiative will be made available to the public today on our Web site (www.fda.gov).
Thank you for your support of this important public health initiative.
/s/
Lester M. Crawford, D.V.M., Ph.D.
Press Release, August 21, 2002