USP 药品质量标准.ppt

* * * * * * 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