Editorial: Should We Take Our Relationship to the Next Level?

Manufacturers and ingredient suppliers are working more collaboratively in Numerous ways. Innovation is certainly one way. But what about at the basic level, between buyer and supplier? Michael McGuffin, president of the American Herbal Products Association (AHPA; Silver Spring, MD), posed the question in a recent talk with Nutritional Outlook. Our annual International Buyer’s Guide Directory issue seemed like the perfect time to mention it.

Q: How can the supplier/buyer relationship evolve?
McGuffin: I think we’ll start to see manufacturers asking their ingredient suppliers to provide more information that assists their own compliance needs with regards to [ingredient] specification. I don’t have a specific idea in mind of what this type of collaboration would be. I don’t know if it means some kind of practice in which the ingredient supplier is conducting its own tests for identity and providing the results of those tests to the manufacturer.

But suppose that the supplier of the ingredient-say, chamomile flowers-conducts numerous tests for identity to ensure that its ingredient is in fact chamomile flowers. After performing these tests, the ingredient supplier could send all of that information to the manufacturer about all of the tests performed, as well as the references used and the test results. That could make it easier on the receiving company, which would then know the tests and analysis its supplier performed, which could be useful in conducting its own confirming test or analysis. So yes, I think suppliers can provide better service to manufacturers by sharing their analytical results and methods. They can provide information that helps the manufacturer do its job.

You mentioned a rather novel idea that’s come up in conversation-that the wording of the GMP regulations does not seem to exclude the scenario that an ingredient supplier could be the one to perform identity testing for a manufacturer.
FDA states in the GMP final rule (21 CFR 111.105): “The final rule requires quality control personnel to ensure all appropriate tests and examinations are conducted, and review and approve the results of all tests and examinations, but does not require that quality control personnel conduct the tests or examinations….for the purposes of this final rule, we consider that a quality control operation performed by an individual under contract to you or by another third party is no different than a quality control operation performed by your employees who are designated to perform such operation.”

So could that “individual under contract” be an ingredient supplier?
There’s nothing in the regulation’s wording to say that it couldn’t. You may not, under the rule, rely on a supplier’s certificate of analysis for ingredient identity. But you can hire an analytical lab to do the identity testing. If you’re going to hire an analytical lab, does it have to have the words analytical lab on the door, or could that door say ingredient supplier, if the ingredient supplier is also perfectly able to conduct the analysis? Also, note that the regulations do add: “If, during the course of an inspection, we find the requirements of this final rule were not followed, we will hold you, rather than the contractor or other third party, responsible.”

Are there any concerns with making the ingredient supplier part of a manufacturer’s QC operations?
I’m saying that maybe there is a way for the ingredient supplier to be part of a manufacturer’s operations-but I say that with some concern because I think that we’d have to first ask ourselves whether an ingredient supplier could then cheat the system. What controls could you put in place to make sure that such a relationship doesn’t create opportunities for an unethical supplier who is attempting to market a misidentified ingredient?

But arguably, an ingredient supplier would know best exactly how to tell whether an ingredient is in fact their proprietary brand of ingredient. So it does make sense to have them perform the testing, but again, the question has to be asked of whether you can set up a system so that the finished-product manufacturer-that is, the ingredient supplier’s customer-is sufficiently knowledgeable to prevent acceptance of a misidentified ingredient. At this point, it’s only an idea.  

Jennifer Grebow
Editor-in-Chief