GMP术语中英对照.docxVIP

GMP术语中英对照药物质量体系Pharmaceutical Quality System.纠正和预防措施系统Corrective and Preventive Action,CAPA.质量管理体系Quality Management System,QM.质量保证Quality Assurance,QA.质量控制Quality Control,QC.药品生产质量管理规范Good Manufacturing Practice ,GMP.高层管理者Senior/Top Management.质量方针Quality Policy .质量目标Quality Objective.质量计划Quality Planning.资源管理Resource Management.质量信息交流Internal Communication.持续改进Continuous Improvement.管理评审Management Review.过程方法Process Approach质量授权人Qualified Person,QP(欧盟).质量授权人Authorized Person,AP(WHO).用户需求说明文件User Requirement Specification,URS.试运行Commissioning供应商的验收测试Factory Acceptance Test，FAT.用户工厂的验收测试Site Acceptance Test,SAT.功能标准Functional Speification.确认Qualification.校准Calibration预防性维护Preventive Maintenance维修Repair退役Retirement使用日志(工作日志)Logbook中间控制(过程控制)In-process Controls,IPC.关键工艺参数Critical Process Parameters,CPP.关键质量特性Critical Quality Attributes,CQA.返工Reprocessing重新加工Reworking.验证总计划Validation Master Plan,VMP.技术标准文件Technical Specification,TS.空白批记录Master Batch Record.无菌保证水平Sterility Assurance Level,SAL.工艺设计Process Design工艺性能确认Process Performance Qualification工艺分析技术Process Analytical Technology,PAT.持续工艺核实Continued Process Verification.前验证Prospective Validation.同步验证Concurrent Validation.回顾性验证Retrospective Validation.回收因子Recovery Factor,RF.分组概念Bracketing Concept.计算机化系统Computerized System,CS.计算机化系统验证Computerized System Validation ,CSV.计算机系统Computer System.操作环境Operating Environment.系统标准Sytem Specification配置标准Configuration Specification.设计标准Design Specification.企业资源计划系统ERP.实验室信息系统LIMS.配置管理Configuration Management.业务持续计划Business Continuity Plan.灾难恢复计划Disaster Recovery Plan.备份Backup.恢复Restore.项目负责人Project Manager.业务流程负责人Process Owner.责任用户Responsible User.计算机系统负责人System Owner.关键用户Key User.IT专家Subject Matter Expert,SME.供应商Supplier.开发者Developer.业务流程负责人Process Owner系统负责人System Owner受控业务流程Controlled Process控制系统Controlling System偏差Deviation计划内暂时性偏差Planned Temporary Deviations计划外偏差Unplanned Deviations关键偏差Critical deviation重大偏差Major deviation矫正措施Remedial action总体有效性System effectiveness超标结果Out-of