USP Announces New GMP Audit Program

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The United States Pharmacopeial Convention (USP) recently announced an expansion of the verification services it offers with the launch of a new Good Manufacturing Practice (GMP) audit program for manufacturers of dietary supplements and ingredients.

The new GMP audit certification, officially launched at the Council for Responsible Nutrition’s (CRN; Washington, DC) annual conference on October 22, is entirely separate from other USP Verification programs. However, companies may want to use the new GMP certification as a “stepping stone toward achieving USP’s acclaimed dietary supplement product verification mark,” says USP.

“USP has created the GMP audit program in response to overwhelming demand from industry and manufacturers,” said John Atwater, senior director of verification services, 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.”

USP’s new GMP audit program will require manufacturers to comply with both FDA and USP GMPs. Retailers may be especially interested in certain requirements of the program, such as those relating to recall procedures, expiration dating supported by stability data, and identity testing for all ingredients-even those that are not dietary ingredients, says USP.

USP says manufacturers that achieve a successful GMP audit can apply the results to the USP Verification Program with no additional fees for up to one year. Additionally, USP is offering CRN members a 25% discount to participate in the GMP audit program until April 2016 in recognition of CRN’s support.

“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, 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.”

Read more:

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Alkemist Labs Is Giving Supplement Firms Better Tools for Botanical Testing

Are Contract Manufacturers Satisfying GMP Requirements?

Michael Crane
Associate Editor
Nutritional Outlook Magazine
michael.crane@ubm.com