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FDA Issues New Guidelines for Manufacturers of Biologics

On September 29, 2006 the U.S. Food and Drug Administration (FDA) released enhanced guidelines to improve the manufacturing standards of pharmaceutical and human biological drug products. The existing guidelines for manufacturers are called Good Manufacturing Practices. FDA officials anticipate that the new measures will help pharmaceutical companies lower production costs, improve efficiency, prevent drug shortages and recalls, make greater technological advances, and ultimately produce safer and more effective drugs.         

“This guidance incorporates modern quality principles into FDA’s approach to manufacturing, encouraging industry adoption of new technological advances and integrated quality systems,” said Dr. Janet Woodcock, FDA Deputy Commissioner for Operations.

Read the Quality Systems Approaches to Pharmaceutical Current Good Manufacturing Practice (CGMP) Regulations

Source: America’s Blood Centers Newsletter, October 13, 2006


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