USP药品质量标准

USP:Quality Standards for MedicinesUSP:,药品质量标准,操洪欣,CRM,USP-China,美国与药品标准相关的法律,US Drug Law,Federal Food,Drug,and Cosmetic Act(FFDCA),联邦食品药品化妆品法,Basic text that governs all pharmaceutical,medical device,food,cosmetics,dietary supplements,管理药品、医疗器械、食品、化妆品和膳食补充剂的基本法律,Includes requirements for approval to market a drug,包括对药品上市批准的要求,Portions relevant to USP also apply to biologics,涉及,USP,的部分同样适用于生物制品,FDA regulations,FDA,的法规,Developed by FDA under authority granted by FFDCA,在,FFDCA,法律框架下由,FDA,建立,FDA guidance,FDA,指南,Non-binding,but indicates FDA,s thinking,非法规，但体现,FDA,的考虑,Recognition of USP in FFDCA,Documentary Standards,Section 501(b):,A drug is adulterated,“,if it purports to be or is represented as a drug the name of which is recognized in an official compendium,and its strength differs from,or its quality or purity falls below,the standard set forth in such compendium.Such determination as to strength,quality,or purity shall be made in accordance with the tests or methods of assay set forth in such compendium,”,以下情况判为假药,“,其声称为药典收录的药品名称，而其效力不同于、或其质量或纯度低于药典中所设定的标准。对效力、质量或纯度的判断应当根据药典中所设定的分析方法或测试而得到,”,Section 501(a)(2)(B):,A drug is adulterated if it is not manufactured in accordance with current Good Manufacturing Practices(cGMPs),若药品未按照,cGMP,规范生产视为假药,cGMP regulations require testing of each batch of finished drug product to ensure that it meets defined specifications.,cGMP,法规要求最终产品每批检测，以保证产品符合既定的标准,Section 201(j):,The term,“,official compendium,”,means the official United States Pharmacopeia.National Formulary,or any supplement.,”,术语,“,official compendium,”,意思是法定美国药典,国家处方集及其增补本,FFDCA Requirements for Conformance to USP Documentary Standards,Ultimately,the,product,must conform to the compendial standard.,最终，,制剂产品,必须符合药典标准。,USP-NF method must be used if the company has committed to FDA to use it,or if it is the only appropriate test,以下情况必须使用,USP-NF,方法：如果生产商向,FDA,承诺使用，或者,USP-NF,的方法是唯一恰当的方法,In other cases,manufacturers can use an alternative test method if it is:,其他情况下生产商可以使用替代方法，如果（替代方法）：,At least as stringent as the compendial method and,至少和药典方法一样严格，并且,“,Scientifically sound.,”,“,科学合理,.,”,Manufacturer must assure conformance to USP standard,“,by suitable means,including adequate manufacturing process validation and control.,”,生产商必须,“,通过恰当的方式，包括充分的生产工艺验证和控制,”,保证符合,USP,标准。,FDA will always use the compendial method as the,“,referee test.,”,USP is,“,regulatory analytical procedure,”,FDA,总是使用药典方法作为,“,仲裁方法,”,。,USP,是,“,法定分析方法,”,ORA,CPG Sec.420.400 Performance of Tests for Compendial Requirements on Compendial Products(CPG 7132.05),FFDCA&USP Reference Standards,Physical(Reference)Standards,实物标准（标准品）,USP reference standards are developed to conduct compendial tests with legal presumption of suitability.,USP,标准品开发用来执行药典中的检测，具有法律适用性。,No further characterization required as primary standards.,作为法定标准品不需进一步的标定（直接使用）,FDA guidance requires testing of in-house standard against a primary reference standard(USP or other).,FDA,指南要求内部标准品要按法定标准品（,USP,或其它）标定。,Introduction to United States Pharmacopeia,美国药典委员会简介,8,关于,USP,科学、独立的非营利组织,成立于,1820,年，其出版的,美国药典,-,国家处方集,是被联邦法律认可的美国国家药典。,核心工作是为处方药、非处方药、辅料、食品补充剂和食品成分建立质量标准,全球各地设有分支机构：美国、巴西、印度、中国和瑞士,9,USP,的使命,建立有助于提高药品食品质量、安全性和效用的公共标准及相关方案，以改善全世界人民的,健康状况。,USP,的建立,USP,全球分布,20102015,届专家委员会,13,核心药典项目,美国药典,-,国家处方集,(,USP,NF,),超过,4300,个各论,225,章通则,食品化学法典,(FCC),超过,1000,个各论,150,个通用测试章节,食品补充剂标准,综合,USP-NF,和,FCC,中的相关各论,提供检测方法和标准,提供综合法规信息,-FDA,联邦贸易委员会和产业组织,彩色显微鉴别图，化学结构及色谱图,药典论坛,其他出版物,Type of Article,产品分类,Inclusion Criteria,收录标准,Therapeutics(drug substances,drug products,biologics),治疗性产品（原料药，制剂，生物制品）,USP:,approved by US FDA,已被,FDA,批准,Pending,：,submitted/intended to submit for FDA approval,已递交,FDA,进行审批或准备提交,FDA,进行审批的药物,Non-US:,approved by stringent regulatory authority other than FDA,for marketing outside USA,被,FDA,之外其它严格的药物管理机构批准，并在美国之外上市的药物,Excipients,辅料,NF:,listed on FDAs Inactive Ingredients Database,收录于,FDA,的非活性成分数据库,Dietary Supplements,食品和营养补充剂,DSC:,Listed by FDA as an ODI or NDI(old or new Dietary Ingredient),被,FDA,列入,ODI,或,NDI,Food Ingredients,食品成分,FCC:,Food ingredients legally marketed in any country with a regulatory food safety agency;Commercially available,任何国家经过食品安全机构批准上市的食品成分,USP,标准收录范围,15,USP,标准品,可提供超过,2,500,种标准品,用于支持,FDA,强制执行的,USPNF,中的标准和测试,100.0%,纯度保证,(,标签另有说明除外,),16,药典相关项目,认证服务,(GMP,认证计划,),食品补充剂,食品补充剂原料,药用原辅料,药典培训,协助美国政府国际援助署,（,USAID,）在发展中国家进行促进药品质量的项目,17,USP,与,FDA:,超过一个世纪的合作历史,FDA,和,USP“,通过建立和监控用于医药和保健产业的质量标准共同承担促进公众健康的责任。,USP,标准对,FDA,而言是非常重要的工具，确保（产品）符合我们的监管标准并保障公众免受假药伤害。”,-,FDA,局长,Margaret Hamburg,USP,大会,2010,年,4,月,USP:,药品公共标准建立和修订，包括剂量、纯度、质量、包装和标签,FDA:,执法,安全性,有效性,NDA,/BLA/ANDA,上市前审批,GMP,生产等,.,USP-China Activities Update,USP,中华区总部概况,USP-China,成立于,2007,年,9,月,USP-China Site:USP,中国地区总部地址,上海浦东张江高科李冰路,67,弄,11,号楼,USP-ChinaUSP,中华区总部,Offer technical assistance to customers that use USP compendial methods and reference materials.,向药典和标准品用户提供技术支持,Provide Pharmacopeial Education and training classes in the region,提供药典培训课程,Promote a voluntary cGMP USP Verification Program,推广,USP cGMP,认证项目,Work with industr