Steps forward for US cGMP

The US Food and Drug Administration (FDA) announced this week that it has accomplished the initial objectives outlined in its ongoing initiative to modernise the agency's regulation of pharmaceutical manufacturing and product quality.

This initiative - part of a wider effort to improve and streamline the regulatory process - was launched two years ago by Health and Human Services Secretary Tommy G. Thompson when he created an HHS-wide initiative to review HHS regulations and to oversee changes in regulations. An expert advisory panel was appointed and has since made hundreds of specific recommendations.

"Using state-of-the-art approaches in FDA's many critical review and inspection activities will encourage innovation and continuous improvement in drug manufacturing to minimise production problems, and that will make it easier to get safe, high quality medications to patients who need them,"​ said Mark B. McClellan, Commissioner of Food and Drugs. "These initiatives are part of the Department of Health and Human Services' overall efforts to improve the quality, safety, and cost of medical products. We will focus our attention and resources on the areas of greatest risk, with the goal of encouraging innovation that maximises public health protection and promotion."​

This week's announcements represent an interim step in a major agency-wide initiative on "Pharmaceutical Current Good Manufacturing Practices (cGMPs) for the 21st Century: A Risk Based Approach," a two-year programme which applies to pharmaceuticals, including biological human drugs and veterinary drugs.

The initiative, announced in August 2002, was designed to evaluate and improve upon the agency's approach to reviews and inspections related to the manufacturing of human and animal drugs and biologics.

The main goals of the initiative include ensuring that state-of-the-art pharmaceutical science is used in the regulatory review and inspection policies, encouraging the adoption of new technological advances in high quality and efficient manufacturing by the pharmaceutical industry, and assessing the applicable cGMP requirements relative to the best quality management practices. In addition, strengthening public health protection by implementing risk-based approaches that focus both industry and FDA attention on critical areas for improving product safety and quality and finally, enhancing the consistency and coordination of FDA's drug quality oversight activities.