“USP has created the GMP audit program in response to overwhelming demand from industry and manufacturers,” said John Atwater, Senior Director of Verification Services for USP. “Although we continue to believe Dietary Ingredient and Dietary Supplement Verification Programs are the most comprehensive ways to ensure the quality of a given ingredient or supplement, we believe the GMP audit program is an important addition.”
While the new GMP facility audit program is separate from USP’s existing Verification Program, manufacturers can apply the results of a successful GMP audit to the USP Verification Program with no additional fee for up to a year, said USP.
USP has history with GMPs, with its General Chapter <2750> Manufacturing Practices for Dietary Supplements (1993) predating both DSHEA (1994) and the FDA’s current Good Manufacturing Practices (cGMPs) regulations in 21 Code of Federal Regulations Part 111
USP’s GMP audit program will require manufacturers to comply with both FDA and USP GMPs, which means that manufacturers will exceed FDA cGMPs, said USP in a press release.
The audit program was launched during the Council for Responsible Nutrition’s annual conference for the dietary supplement industry in Palm Springs, CA, and CRN members are eligible for a 25% discount for participation in the GMP audit program until April 2016.
“We welcome efforts by organizations such as USP, a global leader in quality standards, to help dietary supplement companies improve accountability to consumers,” said Steve Mister, President/CEO of the Council for Responsible Nutrition.
“We hope companies will take a serious look at this new initiative and that more and more companies in our industry will seek out ways to promote transparency and demonstrate their commitment to manufacturing and marketing quality products. We’re proud that USP is an Associate CRN member, and pleased that the organization chose to unveil the new program at The Conference.”