USP launches dietary supplement GMP audit program


WASHINGTON - The United States Pharmacopeial Convention last week expanded its verification services to include a new Good Manufacturing Practice audit program for dietary supplement and dietary ingredient manufacturers.


"USP has created the GMP audit program in response to overwhelming demand from industry and manufacturers," stated 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. 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 support from the Council for Responsible Nutrition – 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, president and CEO for CRN. “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 [CRN's] The Conference.” 




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