USP announces updated Ingredient Verification Program

Media Contact:
Anne Bell
(301) 998-6785
adb@usp.org

Rockville, MD, April 23, 2018 — USP has updated its Ingredient Verification Programs (IVP), services that help companies ensure they meet quality standards for ingredients used in the manufacture of dietary supplements and drug products. USP has IVPs for dietary ingredients (IVP-DI), for excipients (IVP-E) and for active pharmaceutical ingredients (IVP-API).

Manufacturers of finished dietary supplements and drug products need to ensure the quality of the ingredients used in their manufacturing processes. USP created the IVP in 2004 to help ingredient manufacturers ensure quality and reduce risk while also providing them with a way to differentiate their ingredients in an increasingly competitive global market.

“Consumers deserve to trust the quality of the dietary supplements and drug products they take,” said John B. Atwater, senior director of USP Verification Services. “We created our Ingredient Verification Programs to provide finished product manufacturers with the assurance that the ingredients they use are held to the highest quality standards and are made using safe, sanitary and well-controlled manufacturing practices, which is necessary for them to make quality health products for consumers.”

All IVP programs have been updated to require annual GMP audits, and continued quality control and manufacturing product documentation evaluation and product testing. In addition, the IVP-DI revisions will help suppliers ensure ingredient quality remains current with applicable new good manufacturing practice (GMP) regulations recently put in place by the FDA. The ICH Q7 GMP guidelines developed by the International Conference on Harmonisation for active pharmaceutical ingredients have been replaced with the latest requirements under the U.S. Food and Drug Administration’s (FDA) Food Safety Modernization Act (FSMA), with guidelines following food GMPs in 21 Code of Federal Regulations 117, as well as additional GMP requirements in USP general chapter <2750> for dietary ingredients.

USP is pleased to recognize 15 participants that have completed the USP IVP and that are listed on the USP website at uspverified.org. All have been awarded a Certificate of Standards Compliance and use of the distinctive USP Verified Mark.

For more information on USP’s ingredient verification service offerings and available support resources, visit https://www.usp.org/verification-services, or contact Ed Wyszumiala, director of customer engagement at epw@usp.org.

About USP’s Ingredient Verification Programs

USP’s Ingredient Verification Programs offer rigorous third-party verification services to help manufacturers achieve quality management for ingredients used in the manufacture of finished drug products and dietary supplements. Companies whose ingredients meet USP’s comprehensive and stringent verification requirements, are awarded a Certificate of Standards Compliance and use of the appropriate USP Verified Mark. The Mark can be used on the bulk label of each container of USP-verified ingredients, on the certificate of analysis, and on marketing collateral. USP is an authoritative source for GMP verification services, because the United States Pharmacopeia-National Formulary (USP-NF) is recognized as an official compendium of scientific quality standards for drugs, dietary supplements and their ingredients.


About USP

USP is an independent non-profit organization that collaborates with the world’s top health and science experts to develop high-quality standards that set the bar for manufacturing and distributing safe and effective medicines, supplements and food around the globe. Two billion people world-wide have access to quality medicines, dietary supplements and food as a result of USP’s standards, advocacy and education.