November 01, 2002


 FDA to enhance pharmaceutical good manufacturing practices

Posted Oct. 15, 2002 

The Food and Drug Administration in August announced an initiative to enhance the regulation of pharmaceutical manufacturing and product quality. The initiative focuses on the FDA's current good manufacturing practice program and will cover veterinary and human drugs, including human biological drug products, such as vaccines.

This initiative, which could take up to two years, is designed to improve public health promotion and protection by focusing on three major goals that will augment the agency's pharmaceutical product quality assurance programs.

The first goal will be to enhance the focus of the FDA's pharmaceutical manufacturing program requirements more squarely on risks to public health by providing additional regulatory attention and agency resources on those aspects of manufacturing that pose the greatest risk.

The second goal will be to help ensure that the FDA's work in establishing and enforcing pharmaceutical product quality standards does not impede innovation and the introduction of new manufacturing technologies in the pharmaceutical industry.

The third goal will be to enhance the consistency and predictability of the FDA's approach to ensuring production quality and safety among the agency's centers and field components.

According to FDA Deputy Commissioner Lester M. Crawford, the manufacturing program initiative will be overseen by a steering committee comprising representatives from the FDA's Office of Regulatory Affairs, Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research, Center for Veterinary Medicine, and Office of the Commissioner.

In addition, the FDA is expected to solicit the input and participation from manufacturing quality control experts from industry, academia, government, and consumer groups.