* * * * * * 书面标准 ——各论、通则、凡例   about 1400 drug substance monographs;  2000 drug product monographs;  360 excipient monographs Example: Pioglitazone Monograph in USP 34举例：吡格列酮各论,收录于USP34 USP标准建立流程  Scientific Liaison performs technical review and  drafts the monograph (2-3 months) 科学联络人进行技术审核，草拟各论   Monograph is received/development initiated 收到各论，启动流程   Monograph is published for public  review and comment (3 months) 发布各论供公众评议 Scientific Liaison submits all  comments to Expert Committee 科学联络人向专家委员会提交评议 Expert Committee ballots (1-2 months) 专家委员会投票  Monograph is published in official publication  (USP-NF, FCC, etc) (3 months) 各论正式发布 Approved Not approved Standards Acquisition标准收集 We identify sponsors that can propose monographs and reference materials to USP for development into standards 	确定可以提供分析方法和样品的发起方，与USP合作开发制定标准 Sponsors are pharmaceutical, food, and dietary supplement industries, manufacturers, government, academia 	发起方可以是药品，食品，膳食补充剂生产企业，也可以是政府或科研机构 Collaborate with the sponsors to get the right information – test methods, validations, etc. – required for standard development 	与发起方合作获得标准开发所必需的信息，包括测试方法，验证数据等 Where Are the Monographs Coming From标准从何而来 USP would like to work with  more manufacturers from China 	USP希望与更多中国生产商合作建立标准 Example: Pioglitazone Monograph in PF36（1）举例：吡格列酮各论,收录于PF36（1） Reference Standard Development标准品开发 Material is tested and characterized through collaborative testing involving a minimum of three labs—industry, FDA, and USP (3 months) 物料在至少3个实验室进行联合标定-企业，FDA和USP Bulk material is obtained from industry 从企业获取原料 Data from the collaborative study are reviewed by USP staff scientists ( 1week) USP科学人员审核联合标定数据 Compilation of collaborative study is reviewed and  balloted by  USP scientific teams (3 weeks) USP科学小组审核联合标定汇总数据并投票 Once approved, material subdivided, labeled & QC (1-2 months) 批准后，分装、贴标及QC程序  USP Expert Committees review for suitability for use in  USP documentary standards (2 weeks) USP专家委员会审核标准品的适用性 Submit a Reference Standard提交标准品 USP releases about 360 new lots of official Reference Standards yearly  	USP 每年正式发行约360个新批次的标准品  Half are brand new to our catalog, and half are replacement lots for existing standards 	其中半数为新加入的标准品，另有一半为现有标准品的更新批次  USP appreciates your support on RS candidates 	USP 欢迎国内企业提供标准品候选样品 Benefits of Participation参与对于企业的利益 Direct impact in setting the USP specifications for the donated material/monograph  	通过提供样品和方法直接影响USP规格的制定 Competitive advantage, because your standard is used and enforced by regulatory authorities   	竞争优势，因为您的标准是官方标准并被强制执行 Public recognition by USP through its Donor Recognition Program 	通过USP质量标准合作方认可（表彰）计划获得公众认可 Enhanced corporate citizenship image   	有助于提高企业形象 Copies of the multi-laboratory collaborative testing results with traceability to your reference standard 	提供给企业标准品标定的多实验室联合标定结果和可追溯性说明 Donor Recognition Program USP质量标准合作方认可计划 Free workshop registrations 	专题学术讨论会免费注册 Free print subscription to either USP-NF, FCC or DSC 	免费印刷版USP-NF, FCC 或 DSC Free on-site USP Pharmacopeia Education course 	免费现场药典培训 One year, multiple user l
USP 药品质量标准.ppt