FDA Issues Final Manufacturing Quality Systems Guidance For Pharmaceutical Manufacturers
Costa Mesa, CA - The US Food & Drug Administration has issued a final guidance on quality systems, a set of formalized practices and procedures to ensure the quality of pharmaceuticals and human biological drug products during manufacturing.
The final guidance enhances the FDA's current requirements for ensuring manufacturing quality, known as the current Good Manufacturing Practices regulation, officials note.
"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.
The FDA says that following the guidance in "Quality Systems Approaches to Pharmaceutical Current Good Manufacturing Practice (CGMP) Regulations," should help manufacturers maintain consistent high quality and improve efficiency. The document explains the benefits of incorporating modern quality principles, which should help encourage technical advancements into the manufacturing processes, to better ensure safety and efficacy.
Officials stress 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 FDA's Critical Path initiative, which seeks to modernize new drug development. This will help take a drug from lab 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 pharmaceutical manufacturers with the ability to make technological improvements more readily, with appropriate regulatory oversight. The FDA will continue to monitor manufacturing plants through its inspection program, and continue to advance the training of its investigators in the latest technologies.
SOURCE: US Food & Drug Administration