Leading analytical lab Alkemists Laboratories has expanded its service offerings to include a new R&D division focusing on finished product method development, verification & validation.
The new R&D division marks a strategic move to improve the service offerings of the Costa Mesa-based company, known as a pioneer of cGMP botanical identity testing.
“An R&D division has always been in our strategic plan,” said Élan Sudberg, CEO of Alkemists Labs.
“It’s a joy to see our family business grow to a size that can now effectively execute high end analytical projects for companies making label claims on their finished products.”
Finished product testing
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, and start asking a whole new set of questions.
Following a recent warning letter about finished product testing , Loren Israelsen, president, United Natural Products Alliance (UNPA), told us: “We note that FDA continues to deepen the scope of its Section 111-related investigation criteria. Earlier conversations between industry and FDA have largely focused on ingredient identity testing, and rightly so.
“This latest news will no doubt create a heightened awareness among contract manufacturers and brand holders. It’s clear that brand holders should exercise independent due diligence with respect to finished product testing."
Sudberg added: “It’s one thing to quantify, for example, the gingerols in a raw material of Ginger, but the moment that material is combined with another, that same gingerol value may no longer be scientifically valid by the same testing method. This is where our new R&D division steps in to assist our current client base as well as attract and service the quickly growing market of finished products with label claims.”
“In a 483 notice earlier this year, the FDA made clear they are not only hunting for cGMP violations but also companies who market finished products with label claims that have not been verified or validated,” said Sidney Sudberg, CSO of Alkemists Labs.
Alkemists recently expanded its Herbarium – an onsite collection of over 10,000 specimens of ‘herbs of commerce’, and has increased its analytical lab space by 50%, which allowed an increased inventory of Waters HPLC/UPLCs by 20% and its analytical head count by 30%.
Sidney Sudberg added: “Between the array of Waters HPLC’s with various detectors we now have and the regulatory and multidisciplinary industry expertise of Kelly Reins, our Executive Director of Lab Operations & Compliance, we are excited to offer pharmaceutical industry quality services to our current and future customers and continue our mission of Providing Peace of Mind in The Natural Products Industry.”