USP (United States Pharmacopeia) 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 (good manufacturing practice) 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 GMP regulations recently put in place by the FDA. The ICH Q7 GMP guidelines developed by the International Conference on Harmonization 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.
For more information, visit www.usp.org.