常用GMP英文词汇

GMP常见英文缩写AQAI(Automated Quality Assurance Inspection Equipment):在线自动质量保证检查设备API(Active Pharmaceutical Ingredient):活性药物物质,即原料药ANDA(Abbreviated New Drug Application):简化新药申请ADR(Adverse Drug Reaction):不良反应BSE(Bovine Spongiform Encephalopathy):疯牛病BPCS(Business Planning and Control System):业务计划及控制系统BIA(Business impact assessment):商业影响评估cGMP(current Good Manufacturing Practice):现行药品生产质量管理规范CCCD(China Certification Committee for Drugs):中国药品认证委员会CIP(Cleaning In Place):在线清洁CV(Concurrent Validation):同步验证CDER(Center for Drug Evaluation and Research):药品研究与评价中心COA(Certificate Of Analysis):分析报告单CFR(Code of Federal Regulation):(美国)联邦法规CDC(Centers for Disease Control and Prevention):疾病预防控制中心COS/CEP(Certificate of Suitability for European Pharmacopeia):欧洲药典适用性证书CCD(Certification Committee for Drugs):药品认证管理中心CPMP(Committee for Proprietary Medicinal Products):欧洲专利药品委员会CTD(Common Technical Document):通用技术文件CDC(Centers for Disease Control and Prevention):疾病预防控制中心GMP(Good Manufacturing Practice):药品生产质量管理规范ICH(International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use):人用药品注册技术要求国际协调会EU(European Union):欧洲联盟EFPIA(European Federation of Pharmaceutical Industries Associations):欧洲制药工业协会联合会MHW(Ministry of Health and Welfare,Japan):日本厚生省JPMA(Japan Pharmaceutical Manufacturers Association):日本制药工业协会FDA(US Food and Drug Adminiistration):美国食品与药品管理局PRMA(Pharmaceutical Research and Manufacturers of America):美国药物研究和生产联合会WHO(World Health Organization):世界卫生组织IFPMA(International Federation of Pharmaceutical Manufacturers Associations):国际制药工业协会联合会TQC(Total Quality Control),TQM(Total Quality Management):全面质量管理PDCA(Plan,Do,Check,Action):计划,执行,检查,处理QA(Quality Assurance):质量保证QC(Quality Control):质量控制QS(Quality System):质量体系QM(Quality Management):质量管理SOP(Standard Operating Procedure):标准操作规程SMP(Standard Management Procedure):标准管理程序SOR(Standard Operating Record):标准操作记录GEP(Good Engineering Practice):工程设计规范HV AC(Heating Ventilation and Air Conditioning):空调净化系统DQ(Design Qualification):设计确认IQ(Installation Qualification):安装确认OQ(Operational Qualification):运行确认PQ(Performance Qualification):性能确认OOS(Out-Of-Specification):检验不合格;超标PFDS(Process Flow Diagrams):工艺流程图MRA(cMutual Reognition Agreements):现场检查多边认同协议DMF(Drug Master File):EDMF(European Drug Master File）欧盟药物主文件EDQM（European Directorate for Quality Medicines）:欧洲药品质量管理局ORA(Office of Regulatory Affairs):药政事务办公室GGPs(Good Guidance Practices):优良指南规范MOA(Method Of Analysis):分析方法VMP(Validation Master Plan):验证主计划VP(Validation Protocol):验证方案MSDS(Material Safety Data Sheet):物料安全技术说明书NDA(New Drug Application):新药申请OTC(Over-the-counter):非处方INN(International Nonproprietary Name)国际非专有名称USP(the united state pharmacopeia):美国药典NF(National Formulary):(美国)国家药品集GAP(Good Agricultural Practice):中药材种植管理规范GCP(Good Clinical Practice):药物临床试验质量管理规范GLP(Good Laboratory Practice):药物实验室管理规范GSP(Good Supply Practice):药品经营质量管理规范GUP(Good Use Practice):药品使用质量管理规范SM(Starting Material):起始物料PMF(Plant Master File);SMF(Site Master File):工厂主文件EDL(List of Essential Drugs):基本药物目录PI(Package Insert):说明书PCT(Patent Cooperation Treaty):专利合作条约PPAC(Patent Protection Association of China):中国专利保护协会PIC(Person In Charge):负责人PDS(Pharmaceutical Development Services):整体新药研发机构SPC(Summary of Product Characteristics):产品特性摘要。

Approve 批准Artwork 药品标签Authorized Person，AQ WHO关于质量受权人Bacteriostatic Water for Injection 抑菌注射用水Batch-based production 按批次生产Blending 混合Blending batches 混批Calibration 校验Calibration 校准Campaign-based production 阶段性生产Checked 校验Cleanance or site cleaning 清场Cleaning 清洁Cleaning Validation 清洁验证Clinical Trials 临床研究Contamination 污染Contamination Control 污染控制Continuous production 连续生产Contract manufacturing 委托生产Contract Analysis 委托检验Cool Storage 阴凉储存Critical Deviation 关键偏差Critical Process Parameter 关键工艺参数Critical Processing Step 关键操作步骤Cross contamination 交叉污染Design qualification, DQ 设计确认Deviation 偏差Drinking Water 饮用水Dry Place 干燥储存education 个人学历Equipment logbook 设备使用日志Excessive heat 过热Expected Yield, expected 预期收率experience 工作经验Expiry Date 有效期Factory Acceptance Test，FAT 供应商工厂的验收测试Freezer Storage 冷冻储存Holding Time 贮存期I：Implemente 执行Impurity profile 杂质概况In-process Controls 过程控制In-process Sampling 过程取样Installation qualification, IQ 安装确认Intermediate 中间体Logbook 使用日志Maintenance Basic Practice 维护基本实践Maintenance Best Practice 维护最佳实践Maintenance Good Practice 维护良好实践Maintenance Plan 维护计划Maintenance Program 维护管理程序Manufacture 制造Master Cell Bank , MCB 主细胞库mix-ups 混淆Non-conformance 不合格Operation qualification, OQ 运行确认Out of Specification , OOS 超标Performance qualification, PQ 性能确认Preliminary Cell Bank ,PCB 原始细胞库Preventive Maintenance 预防性维护Production 生产Production Operations 生产操作Purified Water 纯化水Qaultiy Assurance，QA 质量保证Qualification 确认Qualified Person，QP 质量受权人Quality Agreement 质量协议Quality Control，QC 质量控制Quality Management，QM 质量管理Quality review 质量审核Quality Unit，QU/Quality Operations，QO质量管理部门Responsible 负责Rechecked 复验Reconciliation 物料平衡Refrigerator Storage 冷藏储存Reject 拒收Retest dates 复验期Risk Assessment 风险评估Room Temperature Storage 室温储存Safety Environment Health, EHS 环境、健康及安全Semi-continuous production 半连续生产Site Acceptance Test，SAT 用户工厂的验收测试Specification 质量标准Stability 稳定性Sterile Purified Water 灭菌纯化水Sterile Water for Inhalation 灭菌吸入用水Sterile Water for Injection 灭菌注射用水Sterile Water for Irrigation 灭菌冲洗用水Subdividing Operation 分装操作Tamper Evidence 防篡改封签Time Limits 生产时限training 培训Update Batch Production Record, BPR 批记录User Requirement Specification, URS 用户需求标准Validation 验证Validation master plan 验证主计划Verification 复核Verification 检定Water for Injection 注射用水Working Cell Bank , WCB 工作细胞库Worst Case 最差情况Yield 收率Yield , actual 实际收率Signature (signed) 签名CIP 在线清洗SIP 在线灭菌消毒MAINTENANCE 维护保养。

制药行业GMP英文词汇Approve 批准Artwork 药品标签Authorized Person，AQ WHO关于质量受权人Bacteriostatic Water for Injection 抑菌注射用水Batch-based production 按批次生产Blending 混合Blending batches 混批Calibration 校验Calibration 校准Campaign-based production 阶段性生产Checked 校验Cleanance or site cleaning 清场Cleaning 清洁Cleaning Validation 清洁验证Clinical Trials 临床研究Contamination 污染Contamination Control 污染控制Continuous production 连续生产Contract manufacturing 委托生产Contract Analysis 委托检验Cool Storage 阴凉储存Critical Deviation 关键偏差Critical Process Parameter 关键工艺参数Critical Processing Step 关键操作步骤Cross contamination 交叉污染Design qualification, DQ 设计确认Deviation 偏差Drinking Water 饮用水Dry Place 干燥储存education 个人学历Equipment logbook 设备使用日志Excessive heat 过热Expected Yield, expected 预期收率experience 工作经验Expiry Date 有效期Factory Acceptance Test，FAT 供应商工厂的验收测试Freezer Storage 冷冻储存Holding Time 贮存期I：Implemente 执行Impurity profile 杂质概况In-process Controls 过程控制In-process Sampling 过程取样Installation qualification, IQ 安装确认Intermediate 中间体Logbook 使用日志Maintenance Basic Practice 维护基本实践Maintenance Best Practice 维护最佳实践Maintenance Good Practice 维护良好实践Maintenance Plan 维护计划Maintenance Program 维护管理程序Manufacture 制造Master Cell Bank , MCB 主细胞库mix-ups 混淆Non-conformance 不合格Operation qualification, OQ 运行确认Out of Specification , OOS 超标Performance qualification, PQ 性能确认Preliminary Cell Bank ,PCB 原始细胞库Preventive Maintenance 预防性维护Production 生产Production Operations 生产操作Purified Water 纯化水Qaultiy Assurance，QA 质量保证Qualification 确认Qualified Person，QP 质量受权人Quality Agreement 质量协议Quality Control，QC 质量控制Quality Management，QM 质量管理Quality review 质量审核Quality Unit，QU/Quality Operations，QO质量管理部门Responsible 负责Rechecked 复验Reconciliation 物料平衡Refrigerator Storage 冷藏储存Reject 拒收Retest dates 复验期Risk Assessment 风险评估Room Temperature Storage 室温储存Safety Environment Health, EHS 环境、健康及安全Semi-continuous production 半连续生产Site Acceptance Test，SAT 用户工厂的验收测试Specification 质量标准Stability 稳定性Sterile Purified Water 灭菌纯化水Sterile Water for Inhalation 灭菌吸入用水Sterile Water for Injection 灭菌注射用水Sterile Water for Irrigation 灭菌冲洗用水Subdividing Operation 分装操作Tamper Evidence 防篡改封签Time Limits 生产时限training 培训Update Batch Production Record, BPR 批记录User Requirement Specification, URS 用户需求标准Validation 验证Validation master plan 验证主计划Verification 复核Verification 检定Water for Injection 注射用水Working Cell Bank , WCB 工作细胞库Worst Case 最差情况Yield 收率Yield , actual 实际收率Signature (signed) 签名CIP 在线清洗SIP 在线灭菌消毒MAINTENANCE 维护保养。

中英名词对照不动的水Stagnant water可接近性Accessibility外加研究法Spiking study抗原决定基Epitope依从性Compliance注射用水Water for injection物理性封闭Physically occluded空白物法Placebo method青霉素类Penicillins非反应性材质Non-reactive material洗涤剂Cleaning agent纯净水Purified water清洁剂Detergent细胞毒剂Cytotoxic最低定量浓度Limit of quantitation最低检测浓度Limit of detection最差状况Worst-case scenario媒介质Medium就地清洁Clean-in place减低的清洁参数Reduced cleaning parameter测试到清洁为止Test until clean无效应No effect荷尔蒙Hormone间隔时间Time frame对数性的移除Log removal滞留Carry over盘尼西林Penicillin头孢子菌素类Cephalosporins薄层层析法Thin layer chromatography篮状试验法Bracketing杂质组合Impurity profile类固醇Steroid警报点Alarm point英中名词对照Accessibility可接近性Alarm point警报点Bracketing篮状试验法Carry over滞留Cephalosporins头孢子菌素类Clean-in place就地清洁Cleaning agent洗涤剂Compliance依从性Cytotoxic细胞毒剂Detergent清洁剂Epitope抗原决定基Hormone荷尔蒙Impurity profile杂质组合Limit of detection最低检测浓度Limit of quantitation最低定量浓度Log removal对数性的移除Medium媒介质No effect无效应Non-reactive material非反应性材质Penicillin盘尼西林Penicillins青霉素类Physically occluded物理性封闭Placebo method空白物法Purified water纯净水Reduced cleaning parameter减低的清洁参数Spiking study外加研究法Stagnant water不动的水Steroid类固醇Test until clean测试到清洁为止Thin layer chromatography薄层层析法Time frame间隔时间Water for injection注射用水Worst-case scenario最差状况EWG:专家工作组MRA：现场检查多边协同协议企业常用缩写5S : 5S管理ABC : 作业制成本制度 (Activity-Based Costing)ABB : 实施作业制预算制度 (Activity-Based Budgeting)ABM : 作业制成本管理 (Activity-Base Management)APS : 先进规画与排程系统 (Advanced Planning and Scheduling) ASP : 应用程式服务供应商（Application Service Provider）ATP : 可承诺量 (Available To Promise)AVL : 认可的供应商清单(Approved Vendor List)BOM : 物料清单 (Bill Of Material)BPR : 企业流程再造 (Business Process Reengineering)BSC : 平衡记分卡 (Balanced ScoreCard)BTF : 计划生产 (Build To Forecast)BTO : 订单生产 (Build To Order)CPM : 要径法 (Critical Path Method)CPM : 每一百万个使用者会有几次抱怨(Complaint per Million)CRM : 客户关系管理 (Customer Relationship Management)CRP : 产能需求规划 (Capacity Requirements Planning)CTO : 客制化生产 (Configuration To Order)DBR : 限制驱导式排程法 (Drum-Buffer-Rope)DMT : 成熟度验证(Design Maturing Testing)DVT : 设计验证(Design Verification Testing)DRP : 运销资源计划 (Distribution Resource Planning)DSS : 决策支援系统 (Decision Support System)EC : 设计变更／工程变更 (Engineer Change)EC : 电子商务 (Electronic Commerce)ECRN : 原件规格更改通知(Engineer Change Request Notice)EDI : 电子资料交换 (Electronic Data Interchange)EIS : 主管决策系统 (Executive Information System)EMC : 电磁相容(Electric Magnetic Capability)EOQ : 基本经济订购量 (Economic Order Quantity)ERP : 企业资源规划 (Enterprise Resource Planning)FAE : 应用工程师(Field Application Engineer)FCST : 预估(Forecast)FMS : 弹性制造系统 (Flexible Manufacture System)FQC : 成品品质管制 (Finish or Final Quality Control)IPQC : 制程品质管制 (In-Process Quality Control)IQC : 进料品质管制 (Incoming Quality Control)ISO : 国际标准组织 (International Organization for Standardization) ISAR : 首批样品认可(Initial Sample Approval Request)JIT : 即时管理 (Just In Time)KM : 知识管理 (Knowledge Management)L4L : 逐批订购法 (Lot-for-Lot)LTC : 最小总成本法 (Least Total Cost)LUC : 最小单位成本 (Least Unit Cost)MES : 制造执行系统 (Manufacturing Execution System)MO : 制令(Manufacture Order)MPS : 主生产排程 (Master Production Schedule)MRO : 请修(购)单(Maintenance Repair Operation)MRP : 物料需求规划 (Material Requirement Planning)MRPII : 制造资源计划 (Manufacturing Resource Planning)NFCF : 更改预估量的通知Notice for Changing ForecastOEM : 委托代工 (Original Equipment Manufacture)ODM : 委托设计与制造 (Original Design & Manufacture)OLAP : 线上分析处理 (On-Line Analytical Processing)OLTP : 线上交易处理 (On-Line Transaction Processing)OPT : 最佳生产技术 (Optimized Production Technology)OQC : 出货品质管制 (Out-going Quality Control)PDCA : PDCA管理循环 (Plan-Do-Check-Action)PDM : 产品资料管理系统 (Product Data Management)PERT : 计画评核术 (Program Evaluation and Review Technique)PO : 订单(Purchase Order)POH : 预估在手量 (Product on Hand)PR : 采购申请Purchase RequestQA : 品质保证(Quality Assurance)QC : 品质管制(Quality Control)QCC : 品管圈 (Quality Control Circle)QE : 品质工程(Quality Engineering)RCCP : 粗略产能规划 (Rough Cut Capacity Planning)RMA : 退货验收Returned Material ApprovalROP : 再订购点 (Re-Order Point)SCM : 供应链管理 (Supply Chain Management)SFC : 现场控制 (Shop Floor Control)SIS : 策略资讯系统 (Strategic Information System)SO : 订单(Sales Order)SOR : 特殊订单需求(Special Order Request)SPC : 统计制程管制 (Statistic Process Control)TOC : 限制理论 (Theory of Constraints)TPM : 全面生产管理Total Production ManagementTQC : 全面品质管制 (Total Quality Control)TQM : 全面品质管理 (Total Quality Management)WIP : 在制品 (Work In Process)品管中英文名词对照表Accuracy准确度Active主动Action评价.处理Activity活动Add加Addition rule加法运算规则Analysis Covariance协方差分析Analysis of Variance方差分析Appraisal Variation评价变差Approved承认ASQC美国质量学会Attribute计数值Audit审核Automatic databaserecovery数据库错误自动回复Average平均数balance平衡Balance sheet资产负债对照表Binomial二项分配Body机构Brainstorming Techniques脑力风暴法 Business Systems Planning企业系统规划Cable电缆Capability能力Cause and Effect matrix因果图.鱼骨图Center line中心线check检查Check Sheets检查表Chi-square Distribution 卡方分布Clutch spring离合器弹簧Coining压印加工Common cause共同原因Complaint 投诉Compound factor调合因素Concept新概念Condenser聚光镜Conformity合格Connection 关联Consumer’s risk消费者之风险Control控制Control characteristic管制特性Control chart管制图Control plan管制计划Correction纠正Correlation Methods相关分析法Cost down降低成本CPI: continuouse Process Improvement连续工序改善Creep渐变Cross Tabulation Tables交叉表CS: customer Sevice客户中心Cushion缓冲Customer顾客DSA: Defects Analysis System缺陷分析系统Data数据Data Collection数据收集Data concentrator资料集中缓存器DCC: Document Control Center文控中心Decision决策.判定Defects per unit单位缺点数Description描述Detection难检度Device装置Digital数字Do执行DOE: Design of Experiments实验设计Element元素Else否则Engineering recbnology工程技术Entropy函数Environmental环境Equipment设备Estimated accumulative frequency计算估计累计数EV: Equipment Variation设备变异Event事件External Failure外部失效,外部缺陷FA: Failure Analysis坏品分析Fact control事实管理Fatique疲劳FMEA: Failure Mode and Effect analysis失效模式与效果分析FPY合格率FQA: Final Quality Assurance最终品质保证FQC: Final Quality control最终品质控制Full-steer完全转向f unction职能Gauge system量测系统Grade等级Gum-roll橡皮滚筒Health meter体重计Heat press冲压粘着Histogram直方图Hi-tech高科技hypergeometric超几何分配hysteresis磁滞现象Improvement改善Inductance电感Information信息Initial review先期审查Inspection检验Internal Failure内部失效,内部缺陷IPQC: In Process Quality Control制程品质控制IQC: Incomming Quality Control来料品质控制ISO: International Organization for Standardization国际标准组织Law of large number大数法则Link连接LCL: Lower Control limit管制下限LQC: Line Quality Control生产线品质控制LSL: Lower Size Limit规格下限Machine机械Manage管理Materials物料Measurement量测Median中位数Miss feed漏送Module,sub-system,sub-unit单位Momentum原动力Monte garlo method原子核分裂热运动法MSA: Measurement System Analysis量测系统分析Multiplication rule乘法运算规则NIST美国标准技术院Normal常态分布Occurrence发生率On.off system 开,关系统Operation Instruction作业指导书Organization组织Parameter参数Parto 柏拉图Parts零件Parts per million不良率Passive消极的,被动的Plan计划Pulse脉冲Policy方针Population群体Power力量,能源PQA: Process Quality Assurance制程品质保证Practice实务Precision精密度preemptive先占式多任务Pressure压缩Prevention预防Probability机率Probability density function机率密度函数Procedure流程Process过程Process capability analysis制程能力分析图Process control and process capability制程管制与制程能力Producer’s risk生产者之风险Product产品Production生产Program方案Projects项目QA: Quality Assurance品质保证QC: Quality Control品质控制QE: Quality Engineering品质工程QFD: Quality Function Desgin品质机能展开Quality质量Quality manual品质手册Quality policy品质政策Random experiment随机试验Random numbers随机数Range全距Record记录Reflow回流Reject拒收Repair返修Repeatusility再现性Reproducibility再生性Requirement要求Residual误差Response响应Responsibilities职责Review评审Reword返工Robustness稳健性Rolled yield直通率RPN: Risk Priority Number风险系数sample抽样,样本Sample space样本空间Sampling with replacement放回抽样Sampling without peplacement不放回抽样Scatter diagram散布图分析Scrap报废Screw螺旋Severity严重度Shot-peening微粒冲击平面法Simple random sampling 简单随机取样Size规格SL: Size Line规格中心线Slip滑动Stratified random sampling 分层随机抽样SOP: Standard Operation Procedure标准作业书SPC: Statistical Process Control统计制程管制Special cause特殊原因Specification规SQA:Source(Supplier) Quality Assurance供货商品质保证Stage sampling分段随机抽样Standard Deviation标准差Sum of squares统计表supplier平方和System供方systematic sampling系统,体系Statistical tables系统抽样Taguchi-method田口方法Technical committees技术委员会Test piece测试片Theory原理Time stamp时间戳印Time-lag延迟Title 标题Torque 转矩Total求和TQC: Total Quality Control全面品质控制TQM: Total Quality Management全面品质管理Traceablity追溯Training培训Transaction processing and logging交易处理Trouble困扰Up and down上和下UCL: Upper Control Limit管制上限USL: Upper Size Limit规格上限Validation确认Variable计量值Variance变异和Vector向量Verification验证Version版本VOC: voice of Customer客户需求VOE: Voice of Engineer工程需求。

GMP常用名词-中英文对照Lot Number –批号见批号(Batch Number)Manufacture –制造物料的接收、原料药的生产、包装、重新包装、贴签、重新贴签、质量控制、放行、贮存和分发以及相关控制的所有操作。

Material –物料原料(起始物料，试剂，溶剂)，工艺辅助用品，中间体，原料药，和包装及贴签材料的统称。

Mother Liquor –母液结晶或分离后剩下的残留液。

母液可能含有未反应的物料、中间体、不同级别的原料药和/或杂质。

它可用于进一步加工。

Packaging Material –包装材料在储运过程中保护中间体或原料药的任何物料。

Procedure –程序对要进行的操作、要采取的预防措施以及与原料药或中间体生产直接或间接相关的方法的描述文件。

Process Aids –工艺辅料除溶剂外，在原料药或中间体生产中起辅助作用、本身不参与化学或生物学反应的物料(例如，助滤剂、活性炭)。

Process Control –工艺控制见中间控制在原料药制备过程中，从接收原料，到工艺加工和原料药包装所涉及的所有操作。

Qualification –确认证明设备或辅助系统，安装正确、工作正常、确实产生预期的结果，并以文件佐证的行为。

确认是验证的一部分，但单独的确认步骤不构成工艺验证。

Quality Assurance (QA) –质量保证以确保所有原料药达到其应用所要求的质量，并维持质量体系为目的的全部组织安排的总和。

Quality Control –质量控制是否符合质量规格的检查或测试。

Quality Unit(s) –质量部门独立于生产部门的履行质量保证和质量控制职责的组织机构。

按照组织机构的大小和结构，可以是单独的QA 和QC部门，或个人，或小组。

Quarantine –待验在实物上或以其它有效方式将物料隔离，等待对其随后的批准或拒收做出决定的状态。

Raw Material –原料用来表示中间体或原料药的生产中要用的起始物料、试剂和溶剂的通用专业名词。

abnormal [æb'nɔ:məl] a. 反常的,不正常的,不规则的abnormalcy [æb'nɔ:məlsi] (=abnormality) n. 反常, 畸形absolute error 绝对误差absorbent [əb'sɔ:bənt] a. 能吸收的n. 吸收剂absorption [əb'sɔ:pʃən] n. 吸收aluminium tube extruding machine 铝管冲挤机ampoule filling an sealing machine 安瓿灌封机Accelerated testing 加速试验Acceptance criteria可接受标准accidental error 随机误差accuracy ['ækjurəsi] n. 准确(性),精确度acetaldehyde [,æsi'tældəhaid] n. 乙醛acetate buffer醋酸盐缓冲液acetic [ə'si:tik] adj.【化学】醋的，醋酸的，乙酸的；含醋的；似醋的；产醋的acetic acid 醋酸acetic anhydride n. [化]乙酸酐, 无水醋acetification [ə,setifi'keiʃən] n. 使变成醋,醋化acetone ['æsitəun] n. 丙酮acetonitrile [,æsitəu'naitril]n. 乙腈(氰甲烷) acetylcholine [ə,si:təl'kəulin] n. 乙酰胆碱acid solvent 酸性溶剂acid-base indicator 酸碱指示剂acid-base titrations 酸碱滴定acidification [ə,sidifi'keiʃɚn] n. 使发酸,酸化,成酸性Acid-Resistant Water Purifier抗酸化机能水制造装置action limit行动限度activated charcoal 活性炭Active Pharmaceutical Ingredient活性药用成分(原料药)=Drug SubstanceActual yield实际产量adapter 接液管ADE Adverse Drug Event 不良药品事件；药品不良事件ADR Adverse Drug Report 不良药品报告；药品不良反应报告ADR：Adverse Drug Reaction 药品不良反应adsorption [æd'sɔ:pʃən] n. 吸附adsorption chromaography 吸附色谱法adulterated [ə'dʌltəreitid] a. 掺入次级品的adverse ['ædvə:s] a. 不利的adversely affect反作用影响adverseness 不利AE：Adverse Event 不良事件aerosol cold-filling machine气雾剂冷灌装机aerosol drug filling-sealing machine气雾剂灌封机组aerosol drug machinery气雾剂机械AERS Adverse Events Reporting System 不良事件报告系统affecting factors testing 影响因素试验Aging Property Tester老化性能测定仪Agravic mixer无重力混合机AIDS Acquired immune deficiency syndrome获得性免疫缺陷综合症；艾滋病air condenser 空气冷凝管air driers手烘器air filtration空气过滤Air Lock气闸air pressure空气压力air stirring type fermenting equipment气流搅拌式发酵罐Airflow 气流airlift fermenting tank气升式发酵罐airlock n. 气锁vt 用气塞堵住Air-stream spraying drier气流喷雾干燥机alcohol ['ælkəhɔl] n. 酒精almost ['ɔ:lməust] adv. 几乎,差不多aluminium tube cap printing machine铝管旋盖机aluminium tube printing machine铝管印字机aluminium tube screwing machine铝管螺纹机ammonium chloride 氯化铵ammonium oxalate 草酸铵amphiprotic solvent 两性溶剂Sample Handling样品处理ampoule ['æmpu:l] 一次用量,安瓶ampoule cleaning and drawing-sealing machine安瓿洗灌封机ampoule cleaning machine安瓿清洗机ampoule cleaning-drying and filling-sealing interlocking machine安瓿洗、烘、灌、封联动机ampoule cutting machine安瓿割圆机ampoule marker安瓿色标机ampoule printing and boxing machine安瓿印字装盒机ampoule printing and packaging machine安瓿印字包装机ampoule printing machine安瓿印字机ampoule sterilization and leakage detector安瓿灭菌检漏设备ampoule tunnel sterilizing machine安瓿隧道式灭菌干燥机analytical [,ænə'litikl] adj. 分析的,解析的analytical methods分析方法Analyzer for Clinic Medicine Concentration临床药物浓度仪Analyzer,Particle Size Distribution Laser Diffraction Device回折/散乱式粒度分布测定装置anhydrous无水Anthracnose炭疽病anti-foaming agent 消泡剂anti-penetration equipment反渗透设备antisepsis [,ænti'sepsis] n. 防腐法,抗菌法API(Active Pharmaceutical Ingredient) 原料药appearance [ə'pirəns] n. 外表,出现,出场、外观application [,æpli'keiʃən] n. 申请n. 应用软件程序approval [ə'pru:vəl] n. 批准,认可,同意,赞同aprotic solvent 无质子溶剂Aqua水剂[拉]aqueous basic solution 碱性溶液Aqueous Ultrasonic Cleaning Systems大型超声波清洗机arrangement [ə'reindʒmənt] n. 安排Artificial Atmospheric Phenomena Simulator人工气候室ASE accelerated solvent extraction 加速溶剂萃取。

GMP英语PIC/S的全称为：Pharmaceutical Inspection Convention/Pharmaceutical Inspection Cooperation Scheme, PIC/S(制药检查草案), 药品检查协会(PIC/S) ,也有人称PIC/S为医药审查会议/合作计划（PIC/S）PIC的权威翻译：药品生产检查相互承认公约API(Active Pharmaceutical Ingredient) 原料药Air Lock 气闸Authorized Person 授权人Batch/Lot 批次Batch Number/Lot-Number 批号；Batch Numbering System 批次编码系统；Batch Records 批记录；Bulk Product 待包装品；Calibration 校正；Clean area洁净区；Consignment （Delivery）托销药品。

FDA（FOOD AND DRUG ADMINISTRATION）：（美国）食品药品管理局IND（INVESTIGATIONAL NEW DRUG）：临床研究申请（指申报阶段,相对于NDA而言）；研究中的新药（指新药开发阶段，相对于新药而言，即临床前研究结束）NDA（NEW DRUG APPLICA TION）：新药申请ANDA（ABBREVIATED NEW DRUG APPLICA TION）：简化新药申请TREA TMENT IND：研究中的新药用于治疗ABBREVIA TED（NEW）DRUG：简化申请的新药DMF（DRUG MASTER FILE）：药物主文件（持有者为谨慎起见而准备的保密资料，可以包括一个或多个人用药物在制备、加工、包装和贮存过程中所涉及的设备、生产过程或物品。

只有在DMF持有者或授权代表以授权书的形式授权给FDA，FDA在审查IND、NDA、ANDA时才能参考其内容）HOLDER：DMF持有者CFR（CODE OF FEDERAL REGULATION）：（美国）联邦法规PANEL：专家小组BA TCH PRODUCTION：批量生产；分批生产BA TCH PRODUCTION RECORDS：生产批号记录POST-OR PRE- MARKET SURVEILLANCE：销售前或销售后监督INFORMED CONSENT：知情同意（患者对治疗或受试者对医疗试验了解后表示同意接受治疗或试验）PRESCRIPTION DRUG：处方药OTC DRUG（OVER—THE—COUNTER DRUG）：非处方药GMP文件常见缩写ABPI Association of the British Pharmaceutical IndustryADR Adverse Drug ReactionAE Adverse EventAIM Active Ingredient ManufacturerANDA Abbreviated New Drug ApplicationANOVA Analysis of V arianceASM: Active Substance ManufacturerA TC Anatomical Therapeutic ChemicalA TX Animal Test Exemption CertificateBAN British Approved NameBIRA British Institute of Regulatory AffairsBNF British National FormularyBP British PharmacopoeiaC of A Certificate of AnalysisC of S Certificate of SuitabilityCENTRE FOR DRUG EVALUA TION (CDE)Centre for Pharmaceutical Administration (CPA)CMS Concerned Member StateCMS每个成员国COS Certificate of SuitabilityCPMP Committee for Proprietary Medicinal ProductsCRA Clinical Research AssociateCRF Case Report FormCRO Contract Research OrganizationCTA Clinical Trial ApplicationCTC Clinical Trial CertificateCTD Common Technical DocumentCTX Clinical Trials ExemptionDDD Defined Daily DoseDGC Daily Global ComparisonDIA Drug Information AssociationDMF Drug Master FileDrug Registration Branch (DR, Product Evaluation & Registration Division, CPAEDQM (European Directorate for the Quality of Medicines) 欧洲联盟药品质量指导委员会EEA欧洲经济地区EGMA European Generics Medicine AssociationELA Established License ApplicationEMEA European Medicines Evaluation AgencyEMEA（European Agency for the Evaluation of Medicinal Products）欧洲联盟药品评价机构EP European PharmacopoeiaEPAR European Public Assessment ReportsESRA European Society of Regulatory AffairsEuropean Pharmacopoeia Commission 欧洲药典委员会FDAFDA Food and Drug AdministrationFinal Evaluation Report (FER)Free Sale Certificates (FSCs)GCP Good Clinical PracticeGCP药品临床研究管理规范GLP Good Laboratory PracticeGLP 药品临床前安全性研究质量管理规范GMP Good Manufacturing PracticeGMP 药品生产质量管理规范GSP药品销售管理规范Health Sciences Authority (HSA)HSA’s Medicines Advisory Committee (MAC)IB Investigators BrochureICH International Conference for HarmonizationIDMC Independent Data-Monitoring CommitteeIEC Independent Ethics CommitteeIND Investigational New DrugINN International Non-proprietary Name International Conference on Harm onization (ICH) IPC In Process ControlIRB Institutional Review BoardLICENCE HOLDERMA Marketing AuthorizationMAA Marketing Authorization ApplicationMAA上市申请MAH Marketing Authorization HolderMAH 销售许可持有者MCA Medicines Control AgencyMHW Ministry of Health and Welfare (Japan)MR Mutual RecognitionMRA美国与欧盟的互认协议MRAs (Mutual Recognition Agreements) 互相認證同意MRFG Mutual Recognition Facilitation GroupMRP Mutual Recognition ProcedureNAS New Active SubstanceNCE New Chemical EntityNDA New Drug ApplicationNew Chemical Entities (NCEs)New Drug Applications (NDAs)NSAID Non Steroidal Anti Inflammatory Drug NTA Notice To ApplicantsOOS Out of SpecificationOTC Over the CounterPAGB Proprietary Association of Great Britain Ph Eur European PharmacopoeiaPIL Patient Information LeafletPL Product LicensePOM Prescription Only Medicine PRODUCT OWNERPSU Periodic Safety UpdatesQA Quality AssuranceQC Quality ControlRAJ Regulatory Affairs JournalRMS Reference Member StateRMS相互认可另一成员国RSD Relative Standard DeviationRx Prescription OnlySAE Serious Adverse EventSMF Site Master FileSOP Standard Operating ProcedureSOP （STANDARD OPERA TION PROCEDURE）标准运作程序SPC Summary of Product CharacteristicsTherapeutic Goods Administration (TGA)USP US PharmacopoeiaVMF V eterinary Master FileVPC V eterinary Products CommitteeA．A．A Addition and Amendments 增补和修订AC Air Conditioner 空调器ADR Adverse Drug Reaction 药物不良反应AFDO Association of Food and Drug Officials 食品与药品官员协会（美国）ACC Accept 接受AQL Acceptable Quality Level 合格质量标准ADNA Abbreviated New Drug Application 简化的新药申请BOM Bill of Material 物料清单BPC Bulk pharmaceutical Chemicals 原料药CBER Center for Biologics Evaluation Research 生物制品评价与研究中心CFU Colony Forming Unit 菌落形成单位DMF Drug Master File 药品管理档案CDER Center for Drug Evaluation and Research 药物评价与研究中心CI Corporate Identity (Image) 企业识别（形象）CIP Cleaning in Place 在线清洗CSI Consumer Safety Inspector 消费者安全调查员CLP Cleaning Line Procedure 在线清洗程序DAL Defect Action Level 缺陷作用水平DEA Drug Enforcement Administration 管制药品管理DS Documentation System 文件系统FDA Food and Drug Administration 食品与药品管理局（美国）GATT General Agreement on Tariffs and Trade 关贸总协会GMP Good Manufacturing Practice 药品生质量管理规范GCP Good Clinical Practice 药品临床实验管理规范GLP Good Laboratory Practice 实验室管理规范GSP Good Supply Practice 药品商业质量规范GRP Good Retail Practice 药品零售业质量管理规范GAP Good Agriculture Practice 药材生产管理规范GVP Good V alidation Practice 验证管理规范GUP Good Use Practice 药品使用规范HVAC Heating V entilation Air Conditioning 空调净化系统ISO International Organization for Standardization 国际标准化组织MOU Memorandum of Understanding 谅解备忘录PF Production File 生产记录用表格OTC Over the Counter (Drug) 非处方药品PLA Product License Application 产品许可申请QA Quality Assurance 质量保证QC Quality Control 质量控制QMP Quality Management Procedure 质量管理程序SDA State Drug Administration 国家药品监督管理局SMP Standard Management Procedure 标准管理程序SOP Standard Operating Procedure 标准操作程序TQC Total Quality Control 全面质量管理USA United States Pharmacopoeia 美国药典。

GMP常用名词-中英文对照Lot Number –批号见批号(Batch Number)Manufacture –制造物料的接收、原料药的生产、包装、重新包装、贴签、重新贴签、质量控制、放行、贮存和分发以及相关控制的所有操作。

Material –物料原料(起始物料，试剂，溶剂)，工艺辅助用品，中间体，原料药，和包装及贴签材料的统称。

Mother Liquor –母液结晶或分离后剩下的残留液。

母液可能含有未反应的物料、中间体、不同级别的原料药和/或杂质。

它可用于进一步加工。

Packaging Material –包装材料在储运过程中保护中间体或原料药的任何物料。

Procedure –程序对要进行的操作、要采取的预防措施以及与原料药或中间体生产直接或间接相关的方法的描述文件。

Process Aids –工艺辅料除溶剂外，在原料药或中间体生产中起辅助作用、本身不参与化学或生物学反应的物料(例如，助滤剂、活性炭)。

Process Control –工艺控制见中间控制在原料药制备过程中，从接收原料，到工艺加工和原料药包装所涉及的所有操作。

Qualification –确认证明设备或辅助系统，安装正确、工作正常、确实产生预期的结果，并以文件佐证的行为。

确认是验证的一部分，但单独的确认步骤不构成工艺验证。

Quality Assurance (QA) –质量保证以确保所有原料药达到其应用所要求的质量，并维持质量体系为目的的全部组织安排的总和。

Quality Control –质量控制是否符合质量规格的检查或测试。

Quality Unit(s) –质量部门独立于生产部门的履行质量保证和质量控制职责的组织机构。

按照组织机构的大小和结构，可以是单独的QA 和QC部门，或个人，或小组。

Quarantine –待验在实物上或以其它有效方式将物料隔离，等待对其随后的批准或拒收做出决定的状态。

Raw Material –原料用来表示中间体或原料药的生产中要用的起始物料、试剂和溶剂的通用专业名词。

GMP词汇一更衣室 Changing Room一更 First Changing Room手消室 Hands Disinfection Room气闸室 Airlock Room洁具室 Cleaning Tools Room清洗室 Cleaning Room模具室 Dies Room内包装室Immediate Package Room安全门 Emergency Door外包清室Outer Package Removing Room 存料间 Storage Room of Raw Materials 粉碎室 Pulverizing Room备料室 Materials Preparing Room硬胶室 Hard Capsules Filling Room软胶室 Soft Capsules Room制粒干燥室 Granulating and Drying Room 总混间 Blending Room中间站 Intermediate Station压片室 Tablets Room Compression Room 包衣室 Coating Room配浆间 Coating Mixture Preparing Room 铝塑包装间 Packing Room传递窗 Transferring Window外包装室Outer Packing Room蒸馏水室Water Purifying Room质检室 Quality Control Room浓配室 Concentrated Solution Room稀配室 Diluted Solution Room BATCH PRODUCTION：批量生产；分批生产BATCH PRODUCTION RECORDS：生产批号记录POST-OR PRE- MARKET SURVEILLANCE：销售前或销售后监督INFORMED CONSENT：知情同意（患者对治疗或受试者对医疗试验了解后表示同意接受治疗或试验）PRESCRIPTION DRUG：处方药OTC DRUG（OVER—THE—COUNTER DRUG）：非处方药U．S．PUBLIC HEALTH SERVICE：美国卫生福利部药品制备preparation of drug products针对 pertain to人用生物制品 biological products for human use补充 supplement代替条例supersede the requlation提议免除proposed exemption一般销售和消费 ordinarily marketed and consumed美德，优点，效力 virtue联邦注册表 FR/federal register人用物品 human foods用于鉴别，测定 shall be applied in determining生产，加工，包装，贮存 manufacture,process,pack,hold,职责和权力responsibility and authority批准和拒收 approve or reject/withhold复查生产记录review production records对qc来说可以获得的shall be available to QC适当的 adequate效价和含量 strength提供证明文件 shall be documented符合 conform to制订完善 sound每装货量 each shipment变质的is subject to deteriorationaccommodation (车，船，飞机等的)预定铺位批号 batch有害微生物 objectionable microorganism联合批号 the number of units准确性，灵敏性，特异性，重复性accuracy, sensitivity, specificity, and reproducibility特征，属性attribute配伍reconstitution设计 project顺势治疗药品 homeopathic drug products可配伍性compatibility标明 purporting to应成文并遵循shall be in writing and shall be followed.可检出水平 detectable levels通过参考文献具体化 incorporated by reference副作用 adeverse/side effect类型 type混放 mixups签收 receipt处理 disposition正压下过滤 be filtered under positive pressure层流或非层流laminar or nonlaminar;无菌环境aseptic conditions照明 lighting通风、空气过滤、空气加热与冷却 Ventilation, air filtration, air heating and cooling.空气输送系统 Air-handling systems附近建筑物immediate premises专用毛巾 single-service towels 进料 Charge-in标示量或规定量labeled or established amount实际产量 Actual yields理论产量 theoretical yields生产周期 the production of a batch of a drug product药品的一致性和完整性uniformity and integrity of drug products崩解时间 Disintegration time溶液的澄明度、溶解完全性及pH值 Clarity, completeness, or pH of solutions稳定性评估 variability estimates装卸 handlingNIH（NATIONAL INSTITUTE OF HEALTH）：（美国）全国卫生研究所CLINICAL TRIAL：临床试验ANIMAL TRIAL：动物试验ACCELERATED APPROVAL：加速批准FDA（FOOD AND DRUG ADMINISTRATION）：（美国）食品药品管理局IND（INVESTIGATIONAL NEW DRUG）：临床研究申请（指申报阶段，相对于NDA而言）；研究中的新药（指新药开发阶段，相对于新药而言，即临床前研究结束）NDA（NEW DRUG APPLICATION）：新药申请ANDA（ABBREVIATED NEW DRUG APPLICATION）：简化新药申请EP诉（EXPORT APPLICATION ）：出口药申请（申请出口不被批准在美国销售的药品）TREATMENT IND：研究中的新药用于治疗ABBREVIATED（NEW）DRUG：简化申请的新药DMF（DRUG MASTER FILE）：药物主文件（持有者为谨慎起见而准备的保密资料，可以包括一个或多个人用药物在制备、加工、包装和贮存过程中所及的设备、生产过程或物品。

GMP常用名词-中英文对照发表于570 天前⁄ 医药相关⁄ 暂无评论⁄ 被围观577 views+Lot Number –批号见批号(Batch Number)Manufacture –制造物料的接收、原料药的生产、包装、重新包装、贴签、重新贴签、质量控制、放行、贮存和分发以及相关控制的所有操作。

Material –物料原料(起始物料，试剂，溶剂)，工艺辅助用品，中间体，原料药，和包装及贴签材料的统称。

Mother Liquor –母液结晶或分离后剩下的残留液。

母液可能含有未反应的物料、中间体、不同级别的原料药和/或杂质。

它可用于进一步加工。

Packaging Material –包装材料在储运过程中保护中间体或原料药的任何物料。

Procedure –程序对要进行的操作、要采取的预防措施以及与原料药或中间体生产直接或间接相关的方法的描述文件。

Process Aids –工艺辅料除溶剂外，在原料药或中间体生产中起辅助作用、本身不参与化学或生物学反应的物料(例如，助滤剂、活性炭)。

Process Control –工艺控制见中间控制Production –生产在原料药制备过程中，从接收原料，到工艺加工和原料药包装所涉及的所有操作。

Qualification –确认证明设备或辅助系统，安装正确、工作正常、确实产生预期的结果，并以文件佐证的行为。

确认是验证的一部分，但单独的确认步骤不构成工艺验证。

Quality Assurance (QA) –质量保证以确保所有原料药达到其应用所要求的质量，并维持质量体系为目的的全部组织安排的总和。

Quality Control –质量控制是否符合质量规格的检查或测试。

Quality Unit(s) –质量部门独立于生产部门的履行质量保证和质量控制职责的组织机构。

按照组织机构的大小和结构，可以是单独的QA 和QC部门，或个人，或小组。

Quarantine –待验在实物上或以其它有效方式将物料隔离，等待对其随后的批准或拒收做出决定的状态。