For the last eight years, Williams served as manager of FDA’s GMP compliance program for dietary supplements. In that time he has witnessed the finalization of the GMP standards under DSHEA and the roll out of the compliance program, starting with large companies, moving through a medium-sized group and finishing with the smallest tier of companies in 2010.
Common GMP problems
In that time, FDA has identified a number of deficiencies among dietary supplement manufacturers. At first, simple sanitation issues were at the forefront. Other issues, such as testing and procedural documentation deficiencies, have been noted in warning letter after warning letter. And most recently, FDA appears to be delving deeper into the testing issue, and moving beyond the question of whether a company merely has a method for testing incoming materials for identity and purity (and testing outgoing finished products as well) and starting to look at whether the testing procedures themselves are scientifically valid for the application where they are being used.
Williams will bring all of this experience to bear in his new role, said Ed Wyszmuiala, general manager of dietary supplement programs for NSF.
“It’s a win for us but it’s also a great win for industry,” Wyszumiala told NutraIngredients-USA.
“I think we are going to see some changes in the program,” he said. “Companies that are audited right now will start to see some additional questions being asked.”
NSF recently suffered a dent in the reputation of its GMP certification program when a company named Beehive Botanicals that had been given a clean bill of GMP health by NSF shortly thereafter received a warning letter from FDA over GMP violations. At that time, Wyszumiala identified “auditor calibration” as one of the things NSF was looking into to try to explain what went wrong in that case. “Auditor calibration,” or making sure that auditors remain current on regulations and on FDA’s current thinking on GMP compliance, is one of the things that Williams can help improve, Wyszumiala said.
“We are looking at additional training classes for auditors and additional training classes for industry,” he said.
In the end, it’s FDA’s view that matters
In a slightly ironic note, his recent role with FDA Williams did many presentations to industry on GMP compliance. One of the slides he’d often show was festooned with logos (including an NSF logo) that companies use to advertise that they’d received GMP certification from a third party group. His message to industry in those presentations: Don’t assume that having one of these certifications means you will pass a GMP inspection. Our inspectors are there to inspect your facility, not your certifications.
“I think his message was, at the current moment they are not going to accept an outside third party certification in lieu of their own work,” Wyszumiala said.
“What we want to make sure is that our certification is the best it can be. (Having Williams on staff) will make sure that it will have that FDA feel to it and the work we do will match FDA’s expectations for industry,” he said.