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GMP compliance levels are ‘all over the place’: Alkemists CEO

By Stephen Daniells, 20-Nov-2012

Related topics: Regulation, GMPs, QA & QC

Current compliance levels to good manufacturing practice (cGMP) are ‘all over the place’, but ‘for the most part there is an increase in compliance’, says the CEO of Alkemists Laboratories.

Elan Sudberg told NutraIngredients-USA at the recent SupplySide West show that “there is a lot of selective compliance in the industry”.

On the topic of finished product testing, Sudberg noted that this is very complicated. “It is one thing to test Milk Thistle identity or silymarin in Milk Thistle, but when you throw that into products with many other ingredients there just aren’t any methods. There aren’t any reference standards for a finished product with silymarin in it.”

“It ends up being very, very expensive, and our clients are starting to understand that. We’re just waiting to see what the FDA has to say about that since there has been no guidance on how to take care of those problems.”

Sudberg advised that companies facing up to an FDA inspection to “trust but verify”.

“You’re supposed to be able to trust the certificates of analysis from your manufacturers, but it’s been said that they are not worth more than the paper they are printed on and we would agreement on that.

“If the industry spends more time showing consumers that they do spend all this effort, money, and time on the quality control as well as the efficacy studies that would be helpful and it would probably change the industry a little bit in a better direction.”