美国药典及其食品补充剂(成分)认证.ppt

UnitedStatesPharmacopeiaandVerificationPrograms（DietarySupplementandIngredient）美国药典及其食品补充剂（成分）认证胡江滨博士VicePresident,USPInternationalGeneralManager，USP-ChinaUSP—AStandards-settingOrganization美国药典—一个致力于标准建立的组织USP’sVerificationPrograms美国药典认证计划USP’sVerificationPrograms美国药典认证计划RigorousUSPVerificationProcess严格的美国药典认证流程USPConventionHeadquartersUSP-ChinaLaboratory美国药典中华区总部实验室USP-ChinaLaboratory美国药典中华区总部实验室ProfessionalEducationCourses药典培训课程UpcomingUSPPharmacopeiaEducationCoursesandWorkshopsinChinaChinaandUSP:PartneringOpportunitiesMemorandaofUnderstanding官方合作：谅解备忘录中美两国药典委员会合作备忘录内容USPDietarySupplementVerification(DSVP)美国药典食品补充剂认证LookfortheUSP-VerifiedMarkonYourDietarySupplements寻找食品补充剂上的USP认证标志USPDietarySupplement--ProductVerification美国药典食品补充剂--产品认证USP31-NF26收载(但不仅限于)
Aloe(driedlatexoftheleaves)
芦荟(干燥后的胶体)
Capsaicin辣椒素
CapsicumOleoresin辣椒油脂
PowderedHawthornLeafwithFlower山楂叶/花(粉状)
PowderedLicorice(Extract)
甘草(提取物)
Lutein(preparation)叶黄素(制品)
Lycopene(preparation)番茄红素(制品)
Garlic(powder,extract,fluidextract,delayed-ReleaseTablets)
大蒜(粉状提取物,液体提取物,缓释片)
Ginger(Powder,Capsules,Tincture)
生姜(粉状物,胶囊,酊剂)
Ginkgo银杏
GinSeng(Asian,American)人参USPDietarySupplement--ProductVerification美国药典食品补充剂--产品认证Pre-AuditCriticalDocumentation预审中关键文件GMPAuditofManufacturingSites生产场地的GMP检查On-SiteAuditandAcceptanceCriteria现场审核和接受标准ProductDocumentation文件审核ProductDocumentation,Continued文件审核LaboratoryTestingofProductSamples样品的实验室测试ReviewofMarkUsage标识使用审核ApprovalProcess批准程序Off-the-ShelfTesting市售产品测试USPVerifiedDietarySupplementsUSP认证的食品补充剂USPDietaryIngredientVerification(IVP)美国药典食品补充剂原料认证USPDietaryIngredientVerification美国药典食品补充剂原料认证GMPAuditofManufacturingSites生产场地的GMP检查BenefitsofUSPIngredientVerificationUSP原料认证项目价值USPVerifiedIngredientsUSP认证的食品补充剂原料USPVerifiedIngredients通过USP饮食补充剂成分认证的列举USPVerifiedIngredients(Cont)通过USP饮食补充剂成分认证的列举(续)SummaryofUSPVerification美国药典认证项目总结Summary—WhyDSVP,IVP总结—为何选择DSVP,IVP认证Summary—WhyUSP总结—为何选择美国药典GoodPharmaceuticalCareforAll为全人类获得优质药品服务USPContactInformation联系USPOn-lineSourcesforInformat