As FDA makes its way through the second round of GMP inspections, the agency is honing on testing deficiencies and looking at whether tests are fit for purpose, Upton told NutraIngredients-USA. The initial inspections of dietary supplement manufacturers found that many were either not doing ID tests at all, or weren’t using the right tests.
“In the first step (of GMP inspections) FDA was focused on identity testing and what they found was that people were using identity tests inappropriately,” Upton said.
The complication has always been that the GMP rules don’t specify which test should be conducted as a nod to the vast complexity of the botanicals business, with thousands of different botanicals and forms thereof being used in industry. Therefore, it is incumbent on the manufacturer to decide what tests to perform, and to have a scientifically valid reason for that decision. And that means having the right people on staff.
“It depends on what product you are making. If you are taking crude material out of the field you need a botanist. If you are using powders you need someone with the chemical or microscopy skills to be able to apply those technologies identify the materials. If you are using extracts, you need a natural products chemist,” Upton said.
“All of the tests are potentially fit for purpose, but it depends on the matrix.”
So gone are the days when companies could pay for a turnkey quality system from a lab. The actually testing work can be outsourced, but the responsibility for making sure it was done correctly can’t.
“A lot of companies do make the mistake to think that they can outsource their quality control process through testing. FDA has made it clear that you out can’t outsource that responsibility. It is ultimately the manufacturer responsibility to say what is the most appropriate test and they have to make sure that that third party lab did the test the right way,” Upton said.
“Ultimately it’s the manufacturer’s responsibility to ensure that correct tests are being performed and that they are being performed correctly. That’s really where FDA is going now,” he said.