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The Food and Drug Administration (FDA) today issued a final guidance on quality systems, a set of formalized practices and procedures to ensure quality of human and veterinary drugs and human biological drug products during manufacturing. This guidance enhances FDA’s current requirements for ensuring manufacturing quality known as the current Good Manufacturing Practices regulation.
“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.
Following the guidance contained in the document “Quality Systems Approaches to Pharmaceutical Current Good Manufacturing Practice (CGMP) Regulations” should help manufacturers maintain consistent high quality and improve efficiency. The document demonstrates to industry the benefits of incorporating modern quality principles which should foster technical advancements into their manufacturing processes to better ensure the safety and efficacy of drugs for people and animals.
The aim also is to help produce drugs more efficiently, which should help lower costs and prevent shortages of critical medicines due to manufacturing failures that can result in production stoppages and recalls. The document contributes to the goals of the agency’s Critical Path initiative (http://www.fda.gov/oc/initiatives/criticalpath/) which seeks to modernize the development of new drugs. This will help take a drug from laboratory development to mass production in a way that can better assure its initial success and continued quality production.
The Quality Systems Guidance is intended to provide manufacturers of pharmaceuticals with the ability to make technological improvements more readily, with appropriate regulatory oversight.
FDA will continue to monitor manufacturing plants through its inspection program and will continue to advance the training of its investigators in the latest technologies.
The full text of the guidance can be found at: http://www.fda.gov/cder/guidance/7260fnl.htm.
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