As FDA moves through the GMP inspection process, lack of sufficient identity testing is an ongoing concern, and is frequently mentioned in warning letters. Many companies were doing little testing. But now that the agency has put industry on alert that testing is mandatory, it starting to emphasize more and more that just having some sort of test is not enough. FDA is holding companies to the standard of scientific validity that is spelled out in the law.
“The first step was, let’s make sure companies have (some sort of) standards. And let’s make sure they apply them. The next phase would include a deeper dive,” Roy Upton, executive director of AHP told NutraIngredients-USA.
“Maybe in the last eight months we’ve started to see FDA starting to question the scientific validity of the standards that are being applied. Before that most of the 483s were saying, you don’t have standards, you don’t have batch records. You don’t have, you don’t have, you don’t have, and you you’ve got to get them.”
“I have certainly experienced in recent inspections that FDA has looked closely at testing methods,” said Justin Prochnow, a lawyer with the firm Greenberg Traurig. “If you show that you have a test, they are not going to just sign off on it.”
No one size fits all
Thousands of botanicals are used in supplements, and there is no one identity test that applies in all cases, and in most cases multiple techniques will need to be used to meet the GMP standards. Except for incoming shipments of whole botanical materials, the squint and sniff method doesn’t work anymore.
“There was a case of a company using organoleptic testing. FDA said, that is a scientifically valid method, but not for powders,” Upton said.
“There was also a report of someone using near infrared. But according to FDA, the methodology used was not sufficient to differentiate the material from similar species. There is also a lot of talk about using DNA testing. DNA testing will tell you the species, but not the plant part. It’s goldenseal, but is it the root or the leaf?”
The webinar series was based on material developed in the past in conjunction with FDA, Upton said.
“What we did do was to refer to an unpublished FDA guidance document on botanical identification. It was developed in 1999, when the GMPs were still in flux, as a collaboration of FDA and an industry working group. They never published that guidance document, but a bunch of us still have it, and the principles that are laid out there are still cogent to GMP compliance,” Upton said.
“But it’s clear from FDA’s recent 483s and warning letters where industry is falling short. This is what the series was based on.”
Upton is main presenter of the series. Other presenters include James Neal-Kababick of Flora Research Labs, Steve Yeager of Mountain Herbs, Elan Sudberg of Alkemists Laboratories and Josef Brinckmann of Traditional Medicinals.
What test is appropriate?
Completion of the entire series will give participants a good understanding of all the tools available to assure quality control, and it will give an idea of when they’re appropriate.
“After everybody goes through the eight part series they are going to have a very good understanding of what the analytical tools are,” Upton said.
“But perhaps more importantly when those tools should and should not be used. Companies tend to have their cookie cutter analytical technique that they use and it just doesn’t work that way in the real world.”
And the series will help companies that use contract manufacturers properly vet those operations, which is a key component of GMP compliance. As FDA has stated in numerous warning letters, the brand holder owns all of the responsibility for the quality control of product as it arrives on the shelf.
“They would have the knowledge to know what questions to ask (of their contract manufacturers). They should be doing some kind of audit,” Upton said.
“If you have properly vetted your suppliers and your manufacturer you can rely on their testing,” Prochnow said.
The webinars cost $100 for a single session and $650 for the whole series. For more inforamtion, contact Roy Upton at firstname.lastname@example.org. Click here to register.