Emerson Ecologics, which distributes a wide range of dietary supplements in the practictioner channel, has altered its quality program in a way that the company hopes will up the GMP compliance ante for its participating suppliers.
“It took us about a year to create and implement the new program,” Jaclyn Chasse, ND, Emerson’s medical director told NutraIngredients-USA. “We had to discontinue about 16 brands. A lot of them had been brought on quite a long time ago, and some of them did not come up to speed on GMP compliance.”
Emerson now has about 275 brands, all of which must meet the minimum requirements of the so-called Partner Level in the Emerson Quality Program, or EQP. This assessment of all distributed brands assures that all dietary supplement products that practitioners select for their patients come from brands that adhere to the standards set forth by Emerson Ecologics, based on federal regulations regarding the manufacture of dietary supplements.
In addition, two higher levels, the Silver and Gold levels, recognize those brands that in Emerson’s estimation have gone above and beyond in their GMP compliance efforts.
“We look at if they have manufacturing process controls in place, that they have SOPs around indentity testing of incoming materials that use scientifically valid methods. It gets down to the level of detail of the specific tests being used,” Chasse said. “We look at things like how do they process product recalls or how do they handle adverse events.”
Chasse said the first iteration of its quality program was put in place in 2009 before full implementation of the GMP regulations, which took effect for the smallest tier of dietary supplement manufacturers—those with fewer than 50 employees—in mid 2010. The middle and biggest tier companies were already supposed to be in compliance. So in that vein, the program was first meant to recognize companies that were ahead of the game.
Now that all companies are supposed to be in compliance, Chasse said the program includes an aspirational element, as a spur for brands to boost their compliance so as to improve their standing within Emerson’s suite of offerings.
“We have seen that in practice. That has been the most exciting part. We have had several brands that have been evaluated as a Silver partner and they want to know what they need to do get to be a Gold partner. Some brands operate in isolation and we believe we can act as a resource to give them information on how they can improve,” she said.
The practitioners can be isolated, too, when it comes to understanding what the GMP regulations mean and how compliance with those affects finished product quality. Emerson offers its practioner partners access to spread sheets lisitng the quality attributes of all the brands so that practioners can compare relative levels of compliance.
“We serve health care practitioners and quality is a concern for them. But it can be technicallly hard to understand for someone outside of the manufacturing end of the business. What kind of testing is being done? We make it easier for practitioners to understand the GMP compliance of various brands,” Chasse said.