USP and its Dietary Supplement Ingredients Verification Program
MCMIA Press Conference
13 August, 2009
About USP
United States Pharmacopeia is an official standards-setting authority for all prescription and over-the-counter medicines and other health care products manufactured or sold in the United States. USP also sets widely recognized standards for food ingredients and dietary supplements. USP's standards are recognized and used in more than 130 countries around the globe, and have helped to ensure public health throughout the world for close to 200 years. U.S.FDA enforces USP standards and USP works very closely with FDA in many areas to safeguard the quality of medical products and the public health .
USP has branch offices and research and development centers in China (Shanghai), India (Hyderabad), and Brazil (Sao Paulo), complementing the headquarters laboratories and offices in Rockville, Maryland, and an office in Switzerland (Basel). USP has a very active Drug Quality Information (DQI) program managed for the US Agency for International Development, helping more than two dozen countries to improve their capacity for ensuring and improving the quality of drugs primarily drugs for malaria, tuberculosis, and HIV. In addition, USP has established relationships with countries in every region of the globe, and those have been expanding rapidly. In June 2009, USP signed three additional Memoranda of Understanding with provincial drug control institutes in China (added to the three earlier agreements with agencies of the China’s SFDA and another provincial institute), nine ASEAN nations, and Vietnam.
USP-China
USP officially opened its China site in September 2007. USP-China site has laboratory facilities and customer service operations. USP–China’s role is to reach out to customers who use USP products and services in the region; to work collaboratively with Chinese regulatory bodies and other parties to help improve the quality of medicines and foods; to conduct collaborative testing of Reference Standards for USP; and to help manufacturers in the region better understand compendial standards required by the U.S. FDA for drugs exported into the United States. For Chinese manufacturers who wish to export pharmaceutical ingredients and products to the United States, adherence to USP standards is mandatory.
USP Verification Programs
USP Verification Programs verifies Pharmaceutical Ingredients, Dietary Supplement Ingredients, and Dietary Supplement products. In the US, many of the botanical products are considered as dietary supplements. USP’s Dietary Supplement Ingredients Verification Program covers Vitamins, Minerals, Amino Acids, Botanicals, and other dietary supplement ingredients covered by DSHEA and legally marketed in the U.S..
Participants of the USP verification programs must go through a comprehensive on-site Good Manufacturing Practices (GMP) audits, thorough documentation reviews and independent product testing for purity and potency. Manufacturers whose ingredients meet the USP requirements are awarded use of the “USP Verified” mark on labels and containers of verified ingredients. Manufacturers can utilize this program to demonstrate that their ingredients are of consistent high quality. With this mark, the users of the ingredient can feel confident that
l The ingredients are consistent in quality from batch to batch.
l The ingredients meet label or specifications for identity, strength, purity, and quality.
l The ingredients are prepared in accordance with accepted manufacturing processes.
l The ingredients meet requirements for acceptable limits of contamination.
Moving forward, USP is looking forward to many more opportunities working with the regulatory bodies, associations such as MCMIA, and industry such as Purapharm in the region to fulfilling USP’s mission of improving the health of people around the world through public standards and related programs that help ensure the quality, safety, and benefit of medicines and foods.
