The United States Pharmacopeial Convention (USP) is expanding its verification services to include a new Good Manufacturing Practice (GMP) audit program for dietary supplement and dietary ingredient manufacturers.

Officially launched on Oct. 22 during a reception at the Council for Responsible Nutrition’s annual conference for the dietary supplement industry in Palm Springs, CA, the program will help to ensure that manufacturers have good quality systems and may help mitigate regulatory risks by preparing manufacturers for Food and Drug Administration (FDA) GMP inspection.

The GMP audit program builds on USP’s 200-year history protecting public health through public standards for medicines, dietary supplements and food ingredients. USP is an authoritative source for dietary supplements GMP audits, not only because the United States Pharmacopeia-National Formulary USP-NF is recognized as an official compendia of scientific quality standards for dietary supplements and ingredients, but also because of USP’s leadership in the area of dietary supplement GMPs.

Published in 1993, USP General Chapter <2750> Manufacturing Practices for Dietary Supplements predates both the Dietary Supplement Health and Education Act and the Food and Drug Administration (FDA) current Good Manufacturing Practices (cGMPs) regulations in 21 Code of Federal Regulations Part 111. 

The USP GMP audit program will complement other USP Verification programs and can serve as a stepping stone toward achieving USP’s acclaimed dietary supplement product verification mark.  

"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. It supports USP's mission by encouraging greater adoption of public standards designed to increase product quality and thereby promotes public health."

USP’s GMP facility audit program provides assurance that manufacturers not only meet FDA cGMPs, but exceed them. That’s because USP’s GMP audit program is the only program that will require manufacturers to comply with both FDA and USP GMPs. USP GMPs include requirements of particular interest to retailers such as recall procedures, expiration dating supported by stability data, and identity testing for all ingredients—not just dietary ingredients.

Although separate from the USP Verification Program, participation in the new GMP facility audit program is recommended for companies considering having their products’ quality verified by USP. Manufacturers can apply the results of a successful GMP audit to the USP Verification Program with no additional fee for up to a year. In recognition of CRN’s support and the launch of the program at the CRN meeting, USP is offering CRN members 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, CRN’s president and CEO. “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.”