GMP 中英文单词比照表
GMP (Good Manufacturing Practice)
FDA (Food and Drug Administration) EMEA (European Medicines Evaluation Agency) QRM  (Quality Risk Management)
Q M 〔Quality Management System〕
QA (Quality Assurance)
QC 〔Quality Control〕
Senior /Top Management
Quality Policy
Quality Objective
Quality Planning
Resource Management
Internal Communication
Continuous Improvement
Management Review
Process Approach QP
〔Qualified Person〕AP
(Authorized Person)
URS (User Requirement Specification) Commissioning
FAT〔Factory Acceptance Test〕
SAT (Site Acceptance Test)
Functional Specification
Qualification
Calibration
Preventive Maintenance
SOP 〔Standard operation procedure〕药品生产质量治理标准食品药品监视治理局
欧洲药品治理局
质量风险治理
质量治理体系
质量保证
质量把握
高层治理者
质量方针
质量目标
质量打算
资源治理
信息沟通
持续改进
治理评审
过程方法
质量授权人
授权人
用户需求说明
试运行
工厂的验收测试
用户工程的验收测试功能标准
确认
校准
预防性维护
标准操作程序
Retirement Management
Equipment Logbook
IPC 〔In-process controls〕
CPP (Critical Process parameters) CQA (Critical Quality Attributes) Reprocessing
Reworking
VMP ( Validation Master Plan)
URS〔User Requirement Specification)
TS 〔Technical Specification)
IQ (Installation Qualification)
OQ  (Operation Qualification )
PQ (Performance Qualification)
DQ 〔Design Qualification〕
Master Batch Record
Process Design
Process Qualification
PPQ 〔Process Performance Qualification〕Continued Process Verification Prospective Validation 退役治理
设备使用日志
中间〔过程〕把握关键工艺参数
关键质量特性
返工
重加工
验证总打算
用户需求说明文件技术标准文件
安装确认
运行确认
性能确认
设计确认
基准批记录
工艺设计
工艺确认
工艺性能确认
持续工艺核实
介绍的前验证
Concurrent Validation Retrospective Validation 同步验证
回忆性验证
CIP〔Cleaning In Place 〕在位清洁
RF 〔Recovery Factor 〕回收因子
CS (Computerized System) 计算打算系统
CSV (Computerized System Validation) 计算机化系统验证QBD〔Quality By Design〕质量源于设计Sy
validation verification
stem Specification 确定系统标准Functional Specification 硬件标准、功能标准Configuration Specification 配置标准
Design Specification 设计标准Configuration Management 配置治理
Business Continuity Plan 业务持续打算Disaster Recovery Plan 灾难恢复打算Backup system 备份系统
Restore 恢复
Project Manager 工程负责人Process Owner 业务流程负责人Responsible User 责任用户
System Owner 计算机系统负责人Key User 关键用户
Supplier /Developer
Controlling System
Major Deviation/ Critical Deviation
CAPA(Corrective Action and Preventive Action) 供给商/开发者
把握系统
重大偏差/ 关键偏差订正与预防措施
Planed Temporary Deviations
Unplanned Deviations CFT
〔Cross-Functional Team〕
Remedial Action
OOS (Out of Specification)
PAR〔Annual Product review〕
Risk Identification
Collect and Organize Information
Risk analysis /evaluation/reduction/acceptance 打算内临时性偏差
打算外偏差
跨职能〔科学〕团队
矫正措施
偏差调查和试验室超标结果产品年度回忆
风险识别
收集和组织信息
风险分析/评估/降低/接收
RRF〔Risk Ranking and Filtering〕风险排列和过滤
PHA ( Preliminary Hazard Analysis) FMEA (Failure Mode Effects Analysis) Hazard Analysis and Critical Control Point FAT〔Fault Tree Analysis〕
BR ( Batch Record)
FAT (Factory Acceptance Test) PLC 〔Programmable Logical control〕初步危害分析
失败模式效果分析
危害分析和关键把握点过失树分析
批记录
工厂验收测试
可编程规律把握器
Metrology Confirmation Drinking water 计量确认饮用水
Purified water
Sterile Purified water
FDS〔Functional Design Specification〕纯化水
灭菌纯化水
功能设计技术说明书
DDS〔Detailed Design Specification〕Impact Assessment
COD (Critical Operating Data) Impurity profile
GEP〔Good Engineering Practice〕Maintenance Basic Practice Rechecked
Audit Trail
Non-value added
Read-only CDs
Master Production and Control Record Starting Materials
reagents
solvents
Process aids
intermediates
APIs
Quality Agreement 具体设计技术说明影响评估
关键运行数据
杂质档案
良好工程实践
根本维护实践
复验
审查追踪
不增加价值的
只读式光盘
主生产和把握记录起始物料
试剂
溶剂
工业助剂
中间体
原料药
质量协议

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