FDA initiative to improve pharmaceutical manufacturing practices - Newsletter - Brief Article

Author: Matthew Neff
Date: March 15, 2003

The U.S. Food and Drug Administration (FDA) recently announced the completion of the first phase of objectives of its initiative to modernize the agency's regulation of pharmaceutical manufacturing and product quality. Some of the objectives that have been achieved include the following: clarifying the scope of the FDA's electronic submission and record-keeping requirements; facilitating continuous improvement and innovation in manufacturing by allowing manufacturers to make certain types of changes in their processes without previous FDA approval; launching a program to identify and address inconsistencies across program areas; focusing FDA resources on inspections that will have the greatest public health impact; and enhancing the agency's expertise in pharmaceutical technologies by hiring additional experts and collaborating with academic groups and external experts. Long-term goals of the initiative include the following: ensuring that state-of-the-art pharmaceutical science is used in the regulatory review and inspection policies; encouraging the adoption of new technologic advances in high-quality and efficient manufacturing by the pharmaceutical industry; strengthening public health protection by implementing risk-based approaches; and enhancing the consistency and coordination of the FDA's drug quality oversight activities. The initiative, "Pharmaceutical Current Good Manufacturing Practices (cGMPs) for the 21st Century: A Risk Based Approach," was designed to evaluate and improve the agency's approach to reviews and inspections related to the manufacturing of human and animal drugs, and biologics. This initiative is part of the Department of Health and Human Services (HHS) Secretary Tommy G. Thompson's broader efforts to improve and streamline the regulatory process to improve Americans' access to quality health care and services.

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