制药相关概念中英文对照

powerba123

CMA Critical Material Attribute 关键物料属性Cp/Cpk Process Capability Index 工序能力指数
CPP Critical Process Parameter 关键工艺参数
CQA Critical Quality Attribute 关键质量属性
CSV Computer System Validation 计算机化系统验证
DCS Distributed Control System 分布式控制系统
DDS Detailed Design Specification 详细设计说明
DNA Deoxyribonucleic acid 脱氧核糖核酸
DOE Design of Experiment 实验设计
DOP Dioctyl Phthalate 邻苯二中酸二辛酯
DQ Design Qualification 设计确认
DS Design Specification 设计说明
EBR Electronic Batch Records 电子批记录
EDI Electrodeionization （US Filter） 电极法去离子（美国滤材）
EHS Environment、Health Safety 环境、健康、安全
El Endotoxin Indicator 内毒素指示剂
ELISA Enzyme-Linked Immuno Sorbent Assay 酶联免疫吸附测定
EMA European Medicines Agency 欧洲药品管理局
EMS Environmental Monitoring System 环境监测系统
EP European Pharmacopoeia 欧洲药典
EPA Environmental Protection Agency 美国环境保护局
EPDM Ethylene-Propylene-Diene Monomer 三元乙丙橡胶
ERP Enterprise Resource Planning 企业资源计划
EU European Union 欧盟
FAT Factory Acceptance Testing 工厂验收测试
FDA Food and Drug Administration 美国食品与药品监督管理局
FDS Functional Design Specification 功能设计说明
FMEA Failure Mode and Effects Analysis 失效模式和影响分析
FS Function Specification 功能说明FTM Fluid Thioglycollate Medium 硫乙醇酸盐液体培养基
GAMP Good Automated Manufacturing Practice 良好自动化生产实践指南
GCP Good Clinical Practice 良好临床管理规范
GDP Good Document Practice 良好文件管理规范
GDP Good Distribution Practice 良好流通管现规范
GEP Good Engineering Practice 良好工程管理规范/良好工程实践
GLP Good Laboratory Practice 良好实验室管理规范
GMP Good Manufacturing Practice 良好生产管理规范/药品生产质量管理规范
GxP Good (Manufacturing，Clinical, Laboratory, 药品（生产、临床、实验室等）管理规范5etc.)
PracticeHACCP Hazard Analysis and Critical Control Points 危害分析和关键控制点
HAZOP Hazard Operability Analysis 危害操作分析
HDS Hardware Design Specification 硬件设计说明
HEPA High Efficiency Particulate Air Filter 高效空气过滤器
HIC Hydrophobic Interaction Chromatography 疏水层析
HIV Human Immunodeficiency Virus 人类免疫缺陷病毒
HMI Human Machine Interface 人机界面
HPLC High Performance Liquid Chromatography 高效液相色谱
HVLD High Voltage Leak Detection 高压电检漏HVAC Heating，Ventilation, and Air Conditioning 采暖、通风和空调系统IEC Ion Exchange Chromatography 离子交换层析I/O Input and Output 输入/输出ICHThe International Conference onHarmonisation of Technical Requirementsfor Pharmaceuticals for Human Use人用药品技术要求国际协调理事会IEC International Electrotechnical Commission 国际电工委员会IQ Installation Qualification 安装确认ISO International Standards Organization 国际标准化组织ISPEThe International Society forPharmaceutical Engineering国际制药工程协会IUPACInternational Union of Pure and AppliedChemistry国际理论（化学）与应用化学联合会kGy Kilogray千戈瑞：1kg 被辐照物质吸收 1 焦耳的能量为 1 戈瑞KPP Key Process Parameter 重要工艺参数续表LIMS Laboratory Information Management System 实验室信息管理系统LOD Limit of Detection 检测限LOQ Limit of Quantitation 定量限LVP Large Volume Parenteral 大容量注射剂MACO Maximum Allowable Carry Over 最大允许残留McAb/mAb Monoclonal antibody 单克隆抗体MCB Master Cell Bank 主细胞库MMF Multi Media Filter 多介质过滤器MSDS Material Safety Data Sheet 化学品安全说明书/安全技术说明书MTDD Minimum Treatment Daily Dosage 最低日治疗剂量6NPDWR National Primary Drinking Water Regulations 美国国家基本饮用水规定OOS Out of Specification 超标准OOT Out of Tendency 超趋势OQ Operational Qualification 运行确认OSD Oral Solid Dosage 口服固体制剂P&.ID Piping and Instrumentation Diagrams 管道仪表图PAO Foly-Alpha-Olcfin 聚α-烯烃PAT Process Analytical Technology 过程分析技术PCB Primary Cell Bank 原始细胞库PDA Parenteral Drug Association 美国注射剂协会PDE Permitted Daily Exposure 允许日暴露水平PEG Polyethylene Glycol 聚乙二醇PEP Project Execution Plan 项目执行计划PFD Process Flow Diagrams 工艺流程图pH Power of Hydrogen 酸喊度PHA Preliminary Hazard Analysis 初步危害分析PIC/SPharmaceutical Inspiration Convcnlion andPharmaceutical Inspection Co-operationScheme国际药品检查协会组织PLC Programmable Logic Controller 可编程逻辑控制器PM Project Management 项目管理PNSU Probability of Non-Sterile Unit 非无菌单元概率PP Polypropylene 聚丙烯PQ Performance Qualification 性能确认PS Pure Steam 纯蒸汽PTFE Polytetrafluoroethylene 聚四氟乙烯PURs Process User Requirements 工艺用户需求PV Process Validation 工艺验证PVC Polyvinyl Chloride 聚氯乙烯PW Purified Water 纯化水PWT Purified Water Tank 纯化水箱QA Quality Assurance 质量保证QbD Quality by Design 质量源于设计QC Quality Control 质量控制QMS Quality Management System 质量管理体系QPP Quality and Project Plan 质量及项目计划QRM Quality Risk Management 质量风险管理QTPP Quality Target Product Profile 质量目标产品档案RA Risk Assessment 风险评估RABS Restricted Access Barrier System 限制进出隔离系统RH Relative Humidity 相对湿度RNA Ribonucleic Acid 核糖核酸7RO Reverse Osmosis 反渗透RSD Relative Standard Deviation 相对标准偏差RTP Rapid Transfer Port 快速运转接口SAL Sterility Assurance Level 无菌保证水平SAM Steam-Air Mixture Process 蒸汽-空气混合气体灭菌程序SAT Site Acceptance Testing 现场验收测试SCADA Supervisory Control and Data Acquisition 检测控制和数据收集SCR Source Code Review 源代码审核SDA Sabouraud Dextrose Agar 沙氏葡萄糖琼脂培养基SDA-PAGE Sodium Dodecyl Sulfate-polyacrylamidegel十二烷基硫酸钠-聚丙烯酰胺凝胶SDI Silt Density Index 淤泥指数SDS Software Design Specification 软件设计说明SIA System Impact Assessment 系统影响性评估SIP Sterilize In Place 在线灭菌SME Subject Matter Expert 主题专家SMP Standard Management Procedure 标准管理规程SOA Service-Oriented Architecture 面向服务的体系结构SOP Standard Operating Procedure 标准操作规程TCU Temperature Control Unit 温度控制单元TM Traceability Matrix 可追溯矩阵TOC Total Organic Carbon 总有机碳TR Technical Report 技术报告TRS Technical Report Series 技术报告系列TSA Tryptose Soya Agar 大豆酪蛋内琼脂培养基TSB Tryptic Soytone Broth 胰酪胨大豆肉汤UAF Unidirectional Airflow 单向流UCL Upper Confidence Limit 置信上限UPS Uninterruptible Power Supply 不间断电源URB User Requirements Brief 用户需求简介URS User Requirements Specification 用户需求说明USP United States Pharmacopoeia 美国药典UV Ultraviolet Light 紫外灯VHP Vaporized Hydrogen Peroxide 汽化过氧化氢VMP Validation Master Plan 验证主计划/验证总计划VP Validation Plan 验证计划WCB Working Cell Bank 工作细胞库WFI Water for Injection 注射用水WHO World Health Organization 世界卫生组织

syhorchid

要想效果好，功夫少不了

大呆子

太多，下次再编辑

我是vvv

未改之前被我看到了

yhdaizy@163.com

重在积累a

aishuxiaohai

不错，楼主辛苦了

wflyxm

有些混乱

powerba123

以后会注意的