QualityStandardsforMedicines,Supplements,andFoodIngredientsthroughouttheWorldUnitedStatesPharmacopeiaandVerificationPrograms(DietarySupplementandIngredient)美国药典(yàodiǎn)及其食品补充剂(成分)认证胡江滨博士VicePresident,USPInternationalGeneralManager,USP-China第一页,共四十五页。Independentandunbiased.独立公正Establishedin1820.188yearsofexperienceinsettingstandards:prescriptionandOTCmedicines,dietarysupplements,andotherhealthcareproducts.成立于1820年,具有188年建立涉及处方药品,非处方药品,食品(shípǐn)补充剂以及其它保健产品标准的经验USPstandards:recognizedbyfederallawintheU.S.andtrustedworldwideusedinover130countries.美国药典标准:美国联邦法律认可的法定标准,全球130多个国家广受信赖第二页,共四十五页。USPiswellknownforitsworkwithactivepharmaceuticalingredientsanddosageforms美国药典因其在药用原料和制剂领域的成就而闻名于世USPhasbeenveryactivewithbotanicals,vitamins,minerals,andothersupplements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USPverificationprogramsprovideassuranceofqualityfromanindependentunbiasedthirdpartyassessment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USPhassetupsitesinChina,IndiaandBrazil.OurglobalpresencecancanbenefittheparticipantsoftheVerificationProgramsandhelpthemtoentertheglobalmarket.美国药典已在中国、印度和巴西设立(shèlì)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。第三页,共四十五页。TheMarkofQuality质量(zhìliàng)的标志第四页,共四十五页。1.下载并阅读《参加者手册》填写申请表ReadParticipantManual.SubmitApplicationForm审计前培训(可选)AuditPreparationWorkshop(Optional)3.按照《参加者手册》程序开始正式审核(文件、现场、样品)FormalProcedureaccordingtotheManual4.全部审核通过后,USP寄发通知函,授予标识使用权和认证证书。USPsendoutthenotificationlettertograntVerificationMark&Certificate.2.签署《许可协议》SigntheLicenseAgreement5.USP网站公布通过企业和原料名称TheParticipant’scompanyandingredientwillbepostedonUSPWebsite第五页,共四十五页。USPConventionHeadqu...