USP said Monday that the program will help ensure that manufacturers have good quality systems and mitigate regulatory risks by readying manufacturers for Food and Drug Administration GMP inspection.
The health standards body noted that it’s an authoritative source for dietary supplement GMP audits, because the U.S. Pharmacopeia-National Formulary (USP-NF) is recognized as an official compendia of scientific quality standards for dietary supplements and ingredients and USP provides leadership specifically 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 GMPs (cGMPs) regulations in 21 Code of Federal Regulations Part 111, according to USP.
The USP GMP audit program will complement other USP Verification programs and provides a step toward achieving USP’s dietary supplement product verification mark.
“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 pointed out that its GMP facility audit program is the only one 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, the standards body said.
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.
“We welcome efforts by organizations such as USP, a global leader in quality standards, to help dietary supplement companies improve accountability to consumers,” commented Steve Mister, president and chief executive officer of the Council for Responsible Nutrition (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.”
The USP GMP audit program was officially launched late last month during a reception at CRN’s annual conference for the dietary supplement industry in Palm Springs, Calif.