ROCKVILLE, Maryland—The US Food and Drug Administration has announced a major new initiative to revise its regulations governing pharmaceutical manufacturing and product quality. Focused on the agency’s current Good Manufacturing Practice (cGMP) program, the new effort seeks to improve public health promotion and protection. It will apply to veterinary and human drugs, including vaccines and other human biological drug products.
The FDA oversees the quality of drugs marketed in the United States by reviewing the safety and efficacy of drug applications and by inspecting manufacturing plants to ensure they conform to the cGMP requirements.
In a memorandum to all FDA employees, deputy commissioner Lester M. Crawford, DVM, PhD, noted that nearly 25 years have passed since the last major revision of the cGMP program.
The initiative—called "The Pharmaceutical cGMPs for the 21st Century: A Risk-Based Approach"—aims at achieving three major goals:
- To focus FDA’s cGMP requirements more squarely on public health by increasing its regulatory activities and resources on aspects of manufacturing that pose the greatest potential risks.
- To ensure that the FDA’s work in establishing and enforcing product quality standards does not slow innovation and the introduction of new manufacturing technologies.
- To enhance the consistency and predictability of the FDA’s approach to assuring quality production and safety among its centers and field components.
"The FDA’s regulatory and quality control systems for pharmaceutical products have become a gold standard for the world," Dr. Crawford said. "Any system can be improved upon, however, and with this risk-based, highly integrative initiative, we intend to do just that."
Three Broad Actions
The agency said it would carry out three broad actions to accomplish the reappraisal: Perform an external review of the existing cGMP program and product review practice, which will include an evaluation of potential inconsistencies in regulations; reassess and reevaluate its product review process and the cGMP program to achieve an integrated systems approach to regulating product quality; and enhance the scientific approach of the cGMPs to emphasize risk-based control point analysis and to facilitate innovations in pharmaceutical engineering.
