FDA to enhance manufacturing practices

November 1, 2002

Pharmaceutical Representative

The Food and Drug Administration has announced that it is undertaking a new initiative to enhance the regulation of pharmaceutical manufacturing and product quality.

The Food and Drug Administration has announced that it is undertaking a new initiative to enhance the regulation of pharmaceutical manufacturing and product quality.

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

"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 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."

Three goals

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

The first goal is to focus the agency's cGMP requirements more squarely on potential risks to public health by providing additional regulatory attention and agency resources for those aspects of manufacturing that pose the greatest potential risk.

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

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

PhRMA applauds initiative

The Washington-based Pharmaceutical Research and Manufacturers of America said it supported the FDA initiative.

"The decision of the FDA to reassess the agency's current approach to pharmaceutical good manufacturing practices … will help ensure that patients continue to benefit from timely access to high-quality pharmaceutical products manufactured according to state-of-the-art, science-based standards," said John T. Kelly, senior vice president for scientific and regulatory affairs for PhRMA. "PhRMA and its member companies are fully committed to working with FDA to assure that appropriate GMP standards are in place to maintain optimum pharmaceutical manufacturing practices for the benefit of patients." PR

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