美国药典 国家处方集 USPNF.ppt

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1、1USP-NF美国药典美国药典/国家处方集国家处方集2OutlinenIntroduction简介nMajor Sections主要章节nRevision修订nSummary小结3IntroductionnUSP Organization Standards DevelopmentThe Revision ProcessnUSP Mission To improve the health of people around the world through public standards and related programs that help ensure the quality an

2、d safety of medicines and foods.n USP组织组织药典标准的制定修订程序n USP使命使命通过提供公共标准及其它相关项目以确保优质安全的药品与食品，促进全人类的健康。4 Lyman Spalding surveyed physicians nationwide between 1817 and 1819 Spalding and 10 fellow physicians met in the U.S.Capitol January 1-7,1820 and the groundwork was laid for establishing the first Ph

3、armacopeia of the United States of America 1817年至1819年，医学博士Lyman Spalding对全国的内科医师进行了调查 1820年1月1-7日，Spalding 和10名内科医师在美国国会大厦会面，完成了第一部美国药典的基础工作How did the U.S.Pharmacopeia begin5How did the U.S.Pharmacopeia begin6 1820-USP Founded:USP standards for 217 drugs 1848-Drug Import Act:USP legislatively mand

4、ated 1906-Federal Pure Food&Drugs Act:USP and NF standards recognized 1938-Federal Food,Drug&Cosmetic Act:USP and NF standards enforceable by FDA 1990-OBRA recognized USP-DI for off-label uses 1994-DSHEA“official compendium”conformity for dietary supplements(voluntary)1820年USP成立：为217种药物制订了USP标准 1848

5、年进口药品法：USP获得法律授权 1906年联邦洁净食品和药品法：美国药典(USP)和国家处方集(NF)标准得到认可 1938年联邦食品、药品和化妆品法：美国药典和国家处方集标准由食品和药品管理局(FDA)强制执行 1990年联邦综合预算调节法(OBRA)认可美国药典/药品信息，供用药参考用 1994年被食品补充剂健康和教育法(DSHEA)认可为食品补充剂的“法定标准”（自愿执行）USPs Legal Recognition7USP：独立的非盈利组织独立的非盈利组织从事药典标准的制定及修订公共标准、规格、纯度、质量、包装和标签全球唯一独立药典机构全球唯一独立药典机构客观、独立的组织更高效的标准

6、制定程序不能使用政府(FDA)机密数据，例如新药标准USP:Private Not-For-Profit Organization Compendial Standards development and revision Public Standards,strength,purity,quality,packaging,labelingThe only non-governmental Pharmacopeia in the world Objective,independentorganization Faster process for standards development No

7、 access to confidential government(FDA)data such as acceptance criteriaUSPs Legal Recognition8 USP is made up of over 1,000volunteers Over 400 members of the USPConvention Council of Experts-56 electedexperts who chair expertcommittees representingstandards and information Over 600 volunteers serve

8、onExpert Committees Board of Trustees-11 electedvoting members USP由1,000多名志愿专家组成 USP委员会有400多名会员 专家主任委员会由56名当选的专家组成，他们分别担任相应标准和信息专家委员会的主席 专家委员会包括600多名专家 理事会由11名有投票权的当选委员组成USPs Volunteer Decision Makers9USP:United States PharmacopeiaNF:National FormularyAvailable formats:Print CD-ROM OnlineUSP-NF Intr

9、oductionPublished annually since 2002USP：美国药典(United States Pharmacopeia)NF:国家处方集(National Formulary)格式：印行本 光盘 在线网络版 自2002年起每年一版10 A compilation of standards andinformation for pharmaceuticals Standards for drug substances,drug products,excipients,dietary supplements General test methods anddefiniti

10、ons Information about relevanttopics 美国医药产品标准和信息汇编 原料药、制剂、辅料、食品补充剂的质量标准 一般测试方法和定义 相关主题的信息USP-NF Introduction11 The process is open.USP strives forinput from various stakeholders:Comments on information found inthe USP-NF or Pharmacopeial Forum Annual Science Meeting Regional Compendial Groups Stakeh

11、olders Forums Industry Forum 标准的制定程序是开放的。USP努力征求所有利益相关人员的意见：关于美国药典/国家处方集或药典论坛信息的意见 年度学术会议 区域性药典团体 利益关系人论坛 制药工业论坛How USP Establishes Standards12Major Sections Front Matter General Notices General Chapters Reagents Reference Tables Dietary Supplements NF Monographs USP Monographs Glossaryl 前言l 凡例l 通则l

12、 试剂l 参考表l 食品补充剂l 国家处方集(NF)各论l USP各论l 术语By-laws,changes from previous USPDefinitions and assumptionsGeneral test methods,information Materials used in monographsDescription,solubility,etc.Dietary Supplements standardsExcipientsDrug substance,product standardsGlossary references细则，修订定义和统计学假设一般测试方法、信息各

13、论中使用的材料溶解度等质量标准辅料质量标准原料药、制剂质量标准术语索引13Front MatterMission and Preface Mission,History,Rules and Procedures（Appendices）People Convention,Council of ExpertsAdmissions Inclusions,omissions and changesCommentary Committees response to comments received about proposal that is official in this aditionAppen

14、dices A:Articles of Incorporation,B:Constitution,C:Rules and procedures,D:Communications Policy,E:Document Disclosure Policy,F:Proceedings,etc.使命和前言 使命、历史、规则和程序（附录）人员 USP委员会、专家主任委员会、合作者修订说明 收载，删减和修改注释 专家委员会对关于本版本中正式生效修订 提议意见的反馈附录 A:组织章程,B:章程与细节,C:规则与程序,D:通讯政策,E:文件公开政策,F:文献汇编等等14General Notices The G

15、eneral Notices and Requirements section(the General Notices)presents the basic assumptions,definitions,and default conditions for the interpretation and application of the United States Pharmacopeia(USP)and the National Formulary(NF).Requirements stated in these General Notices apply to all articles

16、 recognized in the USP and NF(the“compendia”)and to all general chapters unless specifically stated otherwise.凡例部分为USP和NF的解释、应用提供基本假设、定义，及默认的条件。除另有说明，凡例中的要求适用于USP 和NF（或称“药典”）中的所有产品及所有的通则。15You will learn what to do if.在以下情况下，你需要学习 You do not understand a term in USP-NF不理解USP-NF中的术语 You are not sure how to apply an analytical procedure to your product不确定如何将分析方法应用于你的产品 You need to know how containers and closures are defined(soon to bemoved elsewhere)需要了解容器和密闭的要求 You ever fail a certain USP-NF tes