Once GMP inspectors from the FDA move beyond the first tier of GMP compliance, the next big wave of warning letters from the agency could be on the issue of finished product testing, says a leading quality and regulatory expert.
Aaron Secrist, Quality & Regulatory Manager for NOW Foods, told NutraIngredients-USA at the SupplySide West show in Las Vegas last week that, as the inspectors gain more experience and move beyond the first tier GMP compliance issues, they are going to start ask a whole new set of questions.
“Instead of, ‘Are you are doing finished product testing?’ the questions will be, ‘How are you testing? What are you testing? What are you not testing? What is your rationale for not testing?’” said Secrist.
We’ve already seen warning letters from the FDA this year for basic GMP non-compliance issues, and so is the industry ready for the next tier of inspections?
“I think some in the industry are more ready than others,” said Secrist. “I think one of the issues we face in this industry is a real lack of analytical methods and even some standards. Everything in analytical chemistry comes back to the standards.”
“Without the standards and methods in place, it is going to be very hard for the Agency to test these products and determine if they are meeting their finished products specifications.”
“The FDA needs to look at categories of products and start doing a lot of their own work to determine whether or not these products meet their specifications.
“It’s going to require a significant amount of development work on their end, since you don’t find these published in the literature.
“The other difficulty they are going to run into is that every company’s products are slightly different. The make-up of the product, the matrix, is different. Yes, they’re all multivitamins, but some have botanicals and some don’t, all of those things can make it very difficult for companies as well as the agency to test these products.”