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FDA launches '21st century' pharmaceutical good manufacturing initiative

ROCKVILLE, MD., August, 21, 2002 -- The U.S. Food and Drug Administration (FDA) today announced that it is undertaking a significant new initiative to enhance the regulation of pharmaceutical manufacturing and product quality and to bring a 21st century focus to this FDA responsibility.

The initiative focuses on FDA's current good manufacturing practice (cGMP) program and will cover veterinary and human drugs, including human biological drug products such as vaccines.

Nearly 25 years have passed since the last major revisions to the the agency's cGMP regulations.

"Americans expect that their medicines will be of the highest quality, and assuring that quality is one of FDA's core missions," said FDA Deputy Commissioner Dr. Lester M. Crawford.

"FDA's regulatory and quality control systems for pharmaceutical products have become a gold standard for the world, and we Americans should be proud that the quality of the medicines we have available to us and our animals is second to none. Any system can be improved upon, however, and with this risk-based, highly integrative cGMP initiative we intend to do just that.

"We know we can make even a very good system better. Publicizing today this blueprint for action is just the first step."

FDA says this initiative is designed to improve public health promotion and protection by focusing on three major goals that will augment FDA's pharmaceutical product quality assurance programs across the board:

  1. Enhance the focus of the agency's cGMP requirements more squarely on potential risks to public health, by providing additional regulatory attention and agency resources on those aspects of manufacturing that pose the greatest potential risk.
  2. Help ensure that FDA's essential work in establishing and enforcing pharmaceutical product quality standards does not impede innovation and the introduction of new manufacturing technologies in the pharmaceutical industry.
  3. Enhance the consistency and predictability of FDA's approach to assuring production quality and safety among the FDA's centers and field components.

The agency states that it cannot accomplish these goals alone. Given the global nature of pharmaceutical production today, FDA "fully intends to undertake this initiative in close concert and consultation with its regulatory counterparts internationally. In addition, the success of this initiative is strongly dependent on active participation and input from manufacturing quality control experts from industry, academia, government, and consumer groups, and FDA will be actively soliciting such participation as the initiative progresses. "

More than 40 years ago, Congress instructed FDA to require that all drugs be produced according to current good manufacturing practice. This requirement came in response to significant concerns about substandard drug manufacturing practices at that time, and it brought modern quality assurance and control principles to drug manufacturing.

Announcing this cGMP initiative, Dr. Crawford emphasized that it will be overseen by a steering committee that includes representatives from all the affected FDA centers: the Office of Regulatory Affairs, the Center for Drug Evaluation and Research, the Center for Biologics Evaluation and Research, the Center for Veterinary Medicine, and the Office of the Commissioner.

He noted that this task will be driven by the latest science and technology, and will strengthen the public health protection achieved by FDA's regulation of pharmaceutical manufacturing. Dr. Crawford added that FDA remains committed to strong enforcement of the existing regulatory requirements, even as it is examining and revising its approach to these programs.

The concept paper outlining in broad terms the scope and purpose of this initiative, 'Pharmaceutical cGMPs for the 21st Century: A Risk-Based Approach' a set of detailed Questions & Answers; and Dr. Crawford's memorandum to FDA employees on this subject, are available online at

Consumer telephone enquiries: 888-INFO-FDA

Posted: August 2002