Lack of proper specifications has been one of the common features of the 483 observations on inspection reports and on warning letters issued by the U.S. Food and Drug Administration. This documentation failure goes along with other documentation shortcomings, such as improper batch production records, lack of master manufacturing records and so forth.
As FDA dives deeper into the inspections on GMPs, the question of the finer points of the writing of specifications will come up. Along with specifying purity, strength and composition, a product specification ought to also say how a company intends to prove those parameters.
Holly Johnson, PhD, laboratory director for Alkemist Labs, said many companies seem unaware that specifying a test is part of crafting a specification. The exact way this should be done, and the precise test to use, is left vague within the law so as to give flexibility to an industry making a myriad of different products. But vagueness is not a synonym for ‘it would be nice if you could get around to this.’
Specifying a method is part of regulation
“As part of the CFR you must actually specify an analytical method to support your specification. That’s one of the biggest challenges as a third-party lab is try to really suss out with our customers what are their testing needs,” Johnson told NutraIngredients-USA. Johnson was interviewed at the 17th Annual Oxford Conference on the Science of Botanicals which took place last week in Oxford, MS. The conference was organized on by the National Center for Natural Products Research at the University of Mississippi.
Johnson said the testing question is complicated with the trending in the industry toward multi-ingredient blends. These have arise as a point of differentiation and also as a quick way to hook onto the latest trends. If an ingredient gets hot because a mention on the Dr. Oz Show, for example, 30 mg or so of that ingredient shows up in the latest blends.
“Some of our colleagues have coined a term called ‘marketing compounds.’ There is this thing in the industry where people want to put 20 different herbs in a capsule,” Johnson said. “With these blended finished products there aren’t a lot of validated, fit-for-purpose methods available.”
Despite the challenges and the industry’s persistent shortcomings, Johnson said she does believe the industry is gradually getting better.
“Companies are trending toward putting more money toward quality. Instead of maybe 1% to 3% percent of gross revenue, companies are starting to spend more like 8% to 10 % on quality,” Johnson said.