GMP Tips - New Guidance Quality Systems Approach - Oct 2, 2006

We knew it was coming, we just didn’t know when.

Now it’s here, released by FDA on September 29. Here are some excerpts from FDA’s Press Release.

FDA 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 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 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.

This new Guidance, “Quality Systems Approaches to Pharmaceutical Current Good Manufacturing Practice (CGMP) Regulations” 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.

Get your copy of this new Guidance Document. Go to: http://www.gmptrainingsystems.com/asp/resources.asp
Click on FDA Resources

GMP Training Systems, Inc.
www.GMPTrainingSystems.com
Serving 937 clients since 1996

David Markovitz, Founder and President of GMP Training Systems, Inc., will be conducting an audio seminar on Implementing FDA's New Guidance on a Quality Systems Approach on Thursday, October 19. For registration information, go to http://gmptrainingsystems.com/asp/bp_store_061019.asp

Please forward this post to others in your organization who might benefit.