Dispatches from SupplySide West

Industry not ready for increased scrutiny for finished products testing: Alkemists’ CEO


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Related tags Manufacturing

Finished product testing has been predicted to be a key focus for regulatory enforcement as FDA inspectors gain more experience and move beyond the first tier GMP compliance issues, but much of the industry is not yet ready for this increased scrutiny, says the CEO of Alkemists Labs.

Elan Sudberg, CEO of Alkemists Labs, told Stephen Daniells at last week’s SupplySide West show in Las Vegas that it has taken industry a long time to get the 100% identity testing, and some are still trying to figure that part of the GMP regulations out, and it’s going to take a little while to convince industry that the finished product testing is necessary, and for the companies to then adopt that.

“The first main challenge is convincing them that it’s absolutely necessary to prove that what’s on the label is actually in the bottle,”​ said Sudberg. “Second is to develop the methods for very complicated products, some of them have novel, sexy-name ingredients mixed with other novel, sexy-named ingredients, and there are no methods for those things unless the manufacturers actually decide to share that with the labs.

“FDA has shown that finished product testing is on their list. My guess is that we will see more 483s for finished product testing in 2014,”​ he added.  


Anticipating the demands of label claims, Alkemists recently launched R&D division focusing on finished product method development, verification & validation.

Sudberg said that the new R&D division is driving much of the company’s growth. “We’re looking forward to a great year next year with that testing.”

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