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FDA Plans Major Review of cGMP Program

FDA Plans Major Review of cGMP Program

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

"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.


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