美国药典及其食品补充剂(成分)认证.ppt

United States Pharmacopeia and Verification Programs （Dietary Supplement and Ingredient） 美国药典及其食品补充剂（成分）认证胡江滨 博士Vice President, USP InternationalGeneral Manager，USP-China USP—A Standards-setting Organization美国药典 — 一个致力于标准建立的组织 Independent and unbiased. 独立公正 Established in 1820. 188 years of experience in setting standards: prescription and OTC medicines, dietary supplements, and other healthcare products. 成立于1820年, 具有188年建立涉及处方药品,非处方药品, 食品补充剂以及其它保健产品标准的经验 USP standards: recognized by federal law in the U.S. and trusted worldwide used in over 130 countries. 美国药典标准: 美国联邦法律认可的法定标准，全球130多个国家广受信赖 USP’s Verification Programs美国药典认证计划 USP is well known for its work with active pharmaceutical ingredients and dosage forms 美国药典因其在药用原料和制剂领域的成就而闻名于世 USP has been very active with botanicals, vitamins, minerals, and other supplements 美国药典也积极致力于植物类, 维生素, 矿物质和其它补充剂的工作 USP verification programs provide assurance of quality from an independent unbiased third party assessment 美国药典认证项目可以从一个独立公平的第三方评估的角度提供质量保证 USP has set up sites in China, India and Brazil. Our global presence can can benefit the participants of the Verification Programs and help them to enter the global market. 美国药典已在中国、印度和巴西设立分部,我们的全球化运作可以为参加认证的企业拓展国际市场提供帮助。 USP’s Verification Programs美国药典认证计划 The Mark of Quality 质量的标志 Good quality medicines meet official standards for identity, strength, purity, quality, packaging, and labeling. 意味着您的产品是在真伪性,规格,纯度,质量,包装和标签等 方面符合官方标准的质量优良的药品 Rigorous USP Verification Process严格的美国药典认证流程 USP Convention Headquarters USP-China Laboratory美国药典中华区总部实验室 USP-China Laboratory 美国药典中华区总部实验室 Total 1000 square meters, equipped with state-of-art analytical instruments Provide technical assistance for customers in China who use USP standards and methods Offer pharmacopeia training programs Perform USP collaborative testing as part of the reference standard development Support USP Ingredient Verification Program Third party laboratory services such as USP-NPA program Profession