Dispatches from SupplySide West 2013

UNPA chief agrees with FDA that GMP compliance far from uniform

By Hank Schultz

- Last updated on GMT

Related tags Gmp compliance Good manufacturing practice

Adverse event reporting, amphetamine-like substances showing up in products and NDI notifications are all prominent blips on FDA’s radar, said Loren Israelsen, president of the United Natural Products Alliance.

Dr Daniel Fabricant, director of FDA's Office of Dietary Supplement Programs, provided his annual industry report card as SupplySide West, and it behooves industry to pay attention, Israelsen said.

“His overall message on GMP compliance is that we still have a lot of work to do,”​ Israelsen said. “Many companies have made enormous investments in safety and science but that does not seem to be uniform.”

FDA has now done more than 1,000 GMP inspections, Israelsen said, so the agency has more data points than industry observers do as regards overall GMP compliance performance.  So it’s hard to gainsay Fabricant’s position that the industry is not showing a steady improvement, but rather seems to be stuck in neutral.

The best companies are getting better, Isrealsen said.  But a significant portion of the industry is not, and is made up of companies that either don’t understand the requirements or lack sufficient commitment to fully comply.

“That is a concern of both industry leadership and FDA, how to reverse that so that you have really a common steady improvement that is industry wide.  So at this point, it is probably not an accurate statement to say that we have uniform progress with regards to GMPs and quality management,”​ he said.

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