FDA talks about GMPs

Scott Gottlieb, MD, FDA's Deputy Commissioner for Medical and Scientific Affairs addressed the 30th International Good Manufacturing Practices Conference at the University of Georgia College of Pharmacy on March 14, 2006.

His remarks provide insights into what the Agency is thinking. Here's what he said about the GMP regulations.

"The truth is there are important regulatory and technical questions that need to be addressed. But our GMP regulations for drugs haven’t been updated in 25 years. Meanwhile, best practices in manufacturing technologies and methods have undergone significant progress over that time, particularly in other high-tech industries.

For example, the semiconductor industry like the drug industry also has a very low tolerance for impurities and inaccuracies in production. And when its production processes were lagging because of high costs and too many errors that industry helped invent the "six sigma" production methods. Through continuous quality improvement, those methods achieved enormous improvements in production cost and quality, and they have since been widely adopted in manufacturing industries.

But manufacturing hasn’t received its due attention in the pharmaceutical industry, even though many experts on manufacturing processes including many of you here today believe that large savings in production costs could be realized while achieving even higher quality standards. That needs to change. And we need to make sure that our regulations are encouraging and facilitating such progress, which is needed today more than ever."

The good news here is FDA's focus on updating the regulations to encourage and facilitate progress in manufacturing. Stay tuned!

Read Dr. Gottlieb's entire remarks at www.GMPTrainingSystems.com/asp/resources.asp

GMP Training Systems, Inc.
Experience You Can Trust
www.GMPTrainingSystems.com

Our April GMP Boot Camp is full. Our next GMP Boot Camp is scheduled for May 17 - 18 in Newport News, Virginia. Find out how you can attend at www.gmptrainingsystems.com/asp/public_workshops.asp