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FDA Revises Manufacturing Guidelines, Inspection Process

Donna Young

Two years after the Food and Drug Administration (FDA) announced a plan to update its process for regulating pharmaceutical manufacturing and quality, the agency yesterday issued its final report on the initiative and released new draft and final guidance documents, including one on the use of aseptic processing to make sterile drug and biological products.

Janet Woodcock, FDA's acting deputy commissioner for operations, said the agency has been successful in "recrafting" its system for regulating pharmaceutical quality.

Woodcock said she will chair the agency's new Council on Pharmaceutical Quality, which is charged with "implementing the vision that we have developed over the last two years."

The council, she said, will help ensure that the "latest science" will be brought to "bear upon regulation of pharmaceutical quality."

Advances in manufacturing science, quality-management systems, and risk management have yielded modern manufacturing tools that can detect, analyze, correct, and prevent problems, according to FDA.

But drug makers have been reluctant to change their manufacturing processes and equipment "because of perceived, and sometimes real, regulatory hurdles," the agency's report states.

Standards of quality for pharmaceutical products should not impede innovation and the introduction of new manufacturing technologies in the pharmaceutical industry, said John Taylor, FDA's associate commissioner for regulatory affairs.

Regulators, according to the report, plan to reduce the frequency and scope of inspections at manufacturing facilities for "firms that FDA determines have acquired sufficient process understanding and have succeeded in implementing effective quality systems approaches."

"We hope that this approach will create positive incentives for other firms to implement effective quality systems at their manufacturing sites," FDA's report said.

FDA's goal, Taylor said, is to focus the good manufacturing practice (GMP) requirements "more squarely on potential risks to public health and to provide additional regulatory attention of agency resources on those aspects of manufacturing that pose the greatest potential risk."

FDA's risk-based approach for prioritizing manufacturing-site inspections will help the agency "predict where its inspections are likely to achieve the greatest public health impact," the agency stated in its report.

Sterile drug products are a major component in FDA's risk-based inspectional program, according to the agency. FDA's new industry guidance for the use of aseptic processing in making sterile drug products replaces the 1987 guidance document.

Regulators encouraged sterile product manufacturers to implement "good science and modern technology" that will help "lessen or eliminate avoidable risks from aseptic operations."

The adoption of better contamination-prevention practices and a higher assurance of process consistency will reduce the manufacturing problems that lead to drug shortages, FDA stated in its report.

The GMP initiative's "real-world product" may take some time to come to fruition, Taylor said, but "there should be no doubt that FDA remains committed to strong enforcement of the existing GMP requirements even as we are examining and revising our approach to these regulatory programs."