The United States Pharmacopeial Convention is expanding its verification services to include a new Good Manufacturing Practice audit program for dietary supplement and dietary ingredient manufacturers.
The program will help to ensure that manufacturers have good quality systems and may help mitigate regulatory risks by preparing manufacturers for FDAGMP inspection.
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.
"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."