Testing component of specifications often overlooked, expert says

By Hank Schultz contact

- Last updated on GMT

Related tags: Natural products research

Fit for purpose testing continues to be a challenge for dietary supplement companies, says an analytical chemist.

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.

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1 comment

For Own-Label Marketers and Own-Label Distributors...

Posted by Brandon Griffin - Ingredient Identity,

This article is spot on not only for it being a challenge with respect to what laboratories face, but also increasing regulatory agency actions being taken against a variety of companies for not having specs or specific enough info in their specs. The catch-all here is that often manufacturers (who are required to have specifications) don't always share/disclose those specification documents or information with their virtual client counterparts...insert a regulatory conundrum here. This is especially true if using a given company to private label a product for you. What to do if you operate under one of these two business models? One option is to create your own specification sheet, which is a controlled documents that you would manage, but if there are discrepancies or differences between what you have an your manufacturer has, this can get you into trouble. A formulation data sheet is an alternative that allows for as much detail as an OLD or OLM would like to include, but also flexibility for a given manufacturer to create a specification against said document. From there, ensuring a Quality Agreement is in place that cites these specific documents in question so that such can be properly referenced by an outside lab (if being utilized) will save you time and money to be certain, and allow for greater traceability and transparency when it comes to what needs to be tested and how to do so reliably.

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