(整理)药厂功能间中英文对照

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制药常见词汇英文对照

制药常见词汇英文对照中文英文中文英文ICH 颗粒granulation国际协调会议原料药GMP Q7A 粒度particle size原料药API 磨粉milling指导原则guideline 微粉micronizingGMP要求GMP requirements 符合要求Meet therequirements纯度purity 执行v implement物料接收receipt of materials 组织机构organisationalstructure生产production 质量相关事物quality relatedactivities包装packaging 偏差deviation重包装repackaging 关键偏差Critical deviations 贴标labelling 评价evaluation重贴标relabelling 药政检查regulatoryinspections质量控制quality control 严重GMP缺陷serious GMPdeficiencies放行release 审核并批准review and approve储存storage 委派delegate销售distribution 拒收reject安全方面safety aspects 包装物和标签packaging andlabelling materials环境保护protection of theenvironment 实验室控制记录laboratory controlrecord国家法律national laws 标准specifications注册registration 主生产文件master productioninstructions人用药human drug 自检internal auditsself-inspections无菌原料药sterile APIs 合同生产商contractmanufacturers消毒sterilization 验证方案和报告validation protocolsand reports当地药政部门local authorities 投诉complaints化学合成chemical synthesis 维护maintaining提取extraction 校正calibrating发酵fermentation 稳定性数据stability data排除exclude 复验/失效日期retest or expiry dates 临床试验clinical trials 存储条件storage conditions起始物料Starting Material 产品质量回顾product qualityreviews结构单元structural fragment 批生产记录production batchrecords供应商supplier 设施premises化学性质chemical properties 设施变更modified facilities 具体分析case-by-case 证实verify关键步骤critical process 纠偏措施corrective actions前面几部early API steps 工艺的稳定性consistency of theprocess最后几部final steps 分析方法analytical methods 纯化purification 稳定性监控计划stability monitoringprogram分离Isolation 人员资格PersonnelQualifications需要书面写下should be specifiedin writing培训记录Records of training人员卫生Personnel Hygiene 微生物总数total microbialcounts顾问Consultants 控制菌objectionableorganisms潜在污染potential 非无菌non-sterilecontamination微生物标准microbiologicalspecifications专用的Dedicated混淆mix-ups 无水Sewage待验quarantine 垃圾Refuse洗涤剂detergent 卫生Sanitation手烘器air driers 书面程序Written procedures 反作用影响adversely affect 设备维护EquipmentMaintenance蒸汽steam 预防性维护preventativemaintenance通风ventilation 集中生产campaignproduction图纸Drawings 清洗媒介cleaning agents空气过滤air filtration 卸disassembling排气exhaust 连续批号successive batches交叉污染cross-contamination 非专用设备Non-dedicatedequipment空气压力air pressure 可接受标准Acceptance criteria 尘埃dust 残留residues微生物microorganisms 清洁程序cleaning procedures 回风recirculate 状态status管道pipework 预先计划established schedule 中间体intermediate 可追踪的traceable排水沟Drains 对有影响had an impact on饮用水potable water 计算机化系统ComputerizedSystems文件系统DocumentationSystem电子格式electronic form修订历史revision histories 电子签名electronic signatures 扩产报告scale-up reports 中间控制in-process controls 技术转化technical transfer 内控检测in-house testing开发历程报告developmenthistory reports中试规模pilot scale保留期限retention periods 历史数据historical data生产工艺规程Master ProductionInstructions不合格Out-of-specification工艺参数process parameters 混批Blending Batches批量batch size 一级对照品primary standard时间限制time limits 杂质概况impurity profile预期产量expected yield 微生物检测microbiological tests 实际产量Actual yield 商业规模commercial scale关键物料critical materials 留样Retention Samples 进厂物料incoming materials 预验证Prospectivevalidation回顾性验证retrospectivevalidation结晶crystallization不少于not less than 回收溶剂recovered solvents 不大于not more than 母液mother liquors摄氏度centigrade 重新加工Reworking兽用Veterinary use 保留时间retention time氢氧化钠sodium hydroxide 拆分溶液Resolution solution 盐酸hydrochloric acid 水分water甲醇methanol 重金属Heavy metal残留溶剂Residual solvents 流动相Mobile phase炽灼残渣Residue on ignition 柱子column含量Assay 容器Container作一个空白对照Perform a blankdetermination剂型dosage form鉴别Identification 规格strength熔点Melting point 适应症proposed indication 熔程Melting range 给药途径route ofadministration干燥失重Loss on drying 辅料Excipient有关物质Related substance 结构式structural formula比旋度Specific rotation 分子式molecular formula无水anhydrous静态at rest动态in operationGMP车间房间名称中英文对照更衣室? 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。

制药行业术语中英文对照

术语表Acceptance Criteria–接受标准:接受测试结果的数字限度、范围或其他适宜的量度标准。

Active Pharmaceutical Ingredient〔API〕〔or Drug Substance〕-活性要用成分〔原料药〕旨在用于药品制造中的任何一种物质或物质的混合物，而且在用于制药时，成为药品的一种活性成分。

此种物质在疾病的诊断，治疗，病症缓解，处理或疾病的预防中有药理活性或其他直接作用，或者能影响机体的功能和结构。

API Starting Material–原料药的起始物料:用在原料药生产中的，以主要结构单元被并入该原料药的原料、中间体或原料药。

原料药的起始物料可能是在市场上有售，能够根据合同或商业协议从一个或多个供给商处购得，或者自己生产。

原料药的起始物料通常有特定的化学特性和结构。

Batch〔or Lot〕-批:有一个或一系列工艺过程生产的一定数量的物料，因此在规定的限度内是均一的。

在连续生产中，一批可能对应与生产的某以特定局部。

其批量可规定为一个固定数量，或在固定时间间隔内生产的数量。

Batch Number〔or Lot Number〕-批号用于标识一批的一个数字、字母和/或符号的唯一组合，从中可确定生产和销售的历史。

Bioburden–生物负载：可能存在与原料、原料药的起始物料、中间体或原料药中的微生物的水平和种类〔例如，治病的或不治病的〕。

生物负载不应当当作污染，除非含量超标，或者测得治病生物。

Calibration–校验：证明某个仪器或装置在一适当的量程范围内测得的结果与一参照物，或可追溯的标准相比在规定限度内。

Computer System–计算机系统：设计安装用于执行某一项或一组功能的一组硬件元件和关联的软件。

Computerized System–计算机化系统与计算机系统整合的一个工艺或操作。

Contamination–污染：在生产、取样、包装或重新包装、贮存或运输过程中，具化学或微生物性质的杂质或外来物质进入或沾染原料、中间体或原料药。

制药行业术语中英文对照

术语表Acceptance Criteria–接受标准:接受测试结果的数字限度、范围或其他合适的量度标准。

Active Pharmaceutical Ingredient（API）（or Drug Substance）-活性要用成分（原料药）旨在用于药品制造中的任何一种物质或物质的混合物，而且在用于制药时，成为药品的一种活性成分。

此种物质在疾病的诊断，治疗，症状缓解，处理或疾病的预防中有药理活性或其他直接作用，或者能影响机体的功能和结构。

API Starting Material–原料药的起始物料:用在原料药生产中的，以主要结构单元被并入该原料药的原料、中间体或原料药。

原料药的起始物料可能是在市场上有售，能够根据合同或商业协议从一个或多个供应商处购得，或者自己生产。

原料药的起始物料通常有特定的化学特性和结构。

Batch（or Lot）-批:有一个或一系列工艺过程生产的一定数量的物料，因此在规定的限度内是均一的。

在连续生产中，一批可能对应与生产的某以特定部分。

其批量可规定为一个固定数量，或在固定时间间隔内生产的数量。

Batch Number（or Lot Number）-批号用于标识一批的一个数字、字母和/或符号的唯一组合，从中可确定生产和销售的历史。

Bioburden–生物负载：可能存在与原料、原料药的起始物料、中间体或原料药中的微生物的水平和种类（例如，治病的或不治病的）。

生物负载不应当当作污染，除非含量超标，或者测得治病生物。

Calibration–校验：证明某个仪器或装置在一适当的量程范围内测得的结果与一参照物，或可追溯的标准相比在规定限度内。

Computer System–计算机系统：设计安装用于执行某一项或一组功能的一组硬件元件和关联的软件。

Computerized System–计算机化系统与计算机系统整合的一个工艺或操作。

Contamination–污染：在生产、取样、包装或重新包装、贮存或运输过程中，具化学或微生物性质的杂质或外来物质进入或沾染原料、中间体或原料药。

药厂车间名称中英文版

英文Male Changing Room General Changing Room Female Changing Room Materials Entrance Waste Exit Male Toilet Female Toilet Washing Basin HandSterilizer Middle Station Qualified Zone Area To Be Tested Failure Zone LockerLock The Door Please SafetyBe Careful Your Hands Close The Door Please Package Material Entrance Finished Product Exit车间标识中文1. 男更衣室2. 总更衣室3. 女更衣室4. 物料进口5. 废弃物出口6. 男洗手间7. 女洗手间8. 洗手池9. 手消毒器 10.中间站 11.合格区 12.待验区 13.不合格区 14. 更衣柜 15.请把柜门锁好16.注意安全 17.小心伤手 18.随手关门 19.内包材入口21.原料库Material Warehouse22.缓冲间Buffer Room23.紫外线灯UV lamp24.中间品Middle Products25.中控室Central Control Room26.内包车间Inside Package Workshop27.外包车间Outside Package Workshop28.传递窗Transfer Window29.小心有电Electric Careful30.物料运输车Material Transporter31.物料柜Material Cabinet32.温湿度记录Temperature and Humidity Record33.洁净区Cleaning Zone34.洁具间Sanitary Room35.洗衣房Laundry36.造粒车间Granulation workshop37.清洗站Clean Station38.颗粒混合车间Granule Mixing Workshop39.清场合格证Clearance Certification40.生产状态卡Producing Status Card41.保持池内卫生Keeping Cleaning42.物料出口Material Exit。

制药常见词汇英文对照

purity
执行v
implement
物料接收
receipt of materials
组织机构
organisational structure
生产
production
质量相关事物
quality related activities
包装
packaging
偏差
deviation
重包装
repackaging
retrospective validation
结晶
crystallization
不少于
not less than
回收溶剂
recovered solvents
不大于
not more than
母液
mother liquors
摄氏度
centigrade
重新加工
Reworking
兽用
Veterinaryuse
不合格
Out-of-specification
工艺参数
process parameters
混批
Blending Batches
批量
batch size
一级对照品
primary standard
时间限制
time limits
杂质概况
impurity profile
预期产量
expected yield
微生物检测
清洁程序
cleaning procedures
回风
recirculate
状态
status
管道
pipework
预先计划
established schedule
中间体

药厂车间名称中英文版

车间标识中文英文1.男更衣室Male Changing Room2.总更衣室General Changing Room3.女更衣室Female Changing Room4.物料进口Materials Entrance5.废弃物出口Waste Exit6.男洗手间Male Toilet7.女洗手间Female Toilet8.洗手池Washing Basin9.手消毒器Hand Sterilizer10.中间站Middle Station11.合格区Qualified Zone12.待验区Area To Be Tested13.不合格区Failure Zone14.更衣柜Locker15.请把柜门锁好Lock The Door Please16.注意安全Safety17.小心伤手Be Careful Your Hands18.随手关门Close The Door Please19.内包材入口Package Material Entrance20.成品出口Finished Product Exit21.原料库Material Warehouse22.缓冲间Buffer Room23.紫外线灯UV lamp24.中间品Middle Products25.中控室Central Control Room26.内包车间Inside Package Workshop27.外包车间Outside Package Workshop28.传递窗Transfer Window29.小心有电Electric Careful30.物料运输车Material Transporter31.物料柜Material Cabinet32.温湿度记录Temperature and Humidity Record33.洁净区Cleaning Zone34.洁具间Sanitary Room35.洗衣房Laundry36.造粒车间Granulation workshop37.清洗站Clean Station38.颗粒混合车间Granule Mixing Workshop39.清场合格证Clearance Certification40.生产状态卡Producing Status Card41.保持池内卫生Keeping Cleaning42.物料出口Material Exit。

制药行业常用英语词汇中英文对照表

序号
1 2 3 4 5 6 7 8 9 10 11
制药行业常用英语词汇中英文对照
英文原文 Application file Acceptance criteria Active moiety
Additives Adventitious agents Analytical procedures
Anti-microbial Antimicrobial preservatives
83
Glycosylation sites
84
Guidance
85
Guideline
86
Higher order structure
87
Holding times
88
Human or animal origin
89
Immunological activity
90
Immunochemical properties
Solvents
191
Sorption
192
Specifications
193
Specificity
缩小规模模型放大批次
二级/三级/四级结构次级包装章节子章节灵敏度有效期跳检溶解性溶剂吸附质量标准专属性
194
Stability
195
Starting materials
196
Proprietary name
157
Purification steps
158
Purity
159
Quality
160
Quality module
161
Quality overall summary (QOS)

制药常见词汇英文对照

modified facilities
具体分析
case-by-case
证实
verify
关键步骤
critical process
纠偏措施
corrective actions
前面几部
early API steps
工艺的稳定性
consistency of the process
最后几部
final steps
purity
执行v
implement
物料接收
receipt of materials
组织机构
organisational structure
生产
production
质量相关事物
quality related activities
包装
packaging
偏差
deviation
重包装
repackaging
不合格
Out-of-specification
工艺参数
process parameters
混批
Blending Batches
批量
batch size
一级对照品
primary standard
时间限制
time limits
杂质概况
impurity profile
预期产量
expected yield
微生物检测
熔程
Melting range
给药途径
route of administration
干燥失重
Loss on drying
辅料
Excipient
有关物质
Related substance
结构式

药厂功能间中英文对照

外用药车间标牌定做清单
外用药定置区域文字打印
8待清洁工作服56cm*6cm不干胶蓝底白字9WY111016cm＊6cm不干胶蓝底白字10烘手器26cm＊6cm不干胶蓝底白字11洗手液26cm＊6cm不干胶蓝底白字12消毒器16cm＊6cm不干胶蓝底白字13成品暂存区16cm＊6cm不干胶蓝底白字14工作台56cm*6cm不干胶蓝底白字排
15
125cm＊10cm不干胶白底黑字风
16
饮
用
水
115cm＊2cm不干胶白底绿字
17
饮
用
水
115cm＊2cm不干胶白底绿字
18真空115cm*2cm不干胶黑底白字19
真
空
115cm*2cm不干胶黑底白字
20
压
缩
空
气
215cm＊2cm不干胶黑底白字
21
白(黄、蓝、绿)色抹
布43。

5cm*1。

5cm不干胶
相对应的颜色为
底色+黑字
22半成品暂存区16cm＊6cm不干胶蓝底白字
仓库标牌定做清单
房间名称数量单位
字牌尺
寸字体大
小
编号英文名称备注
原辅料常温库1个23*9.520＊7CK1102Raw Temperature Warehouse
仓库驱鼠器编号。

药厂房间中英文对照

Male 2nd Dressing Room Male 2nd Dressing Room Female 1st Dressing Room Female 1st Dressing Room Female 2st Dressing Room Female 2st Dressing Room Hand Disinfection Hand Disinfection IPC Room Moulds Storage Room Laundry Counting Tablets Room Counting Tablets Room Primary Packaging Primary Packaging Primary Packaging Primary Packaging Primary Packaging Transfer Room Rejected Products Storage Primary Packaging Material Room Primary Packaging Material Room Primary Packaging Material Room Buffer Room Buffer Room Cleaning Tools Room Intermediate Station Intermediate Station Elevator Room
Changer Room for Male Changer Room for Male Changer Room for Female Changer Room for Female Unbrella Room Fire Monitoring Male 1st Dressing Room Male 2nd Dressing Room Female 1st Dressing Room Female 2st Dressing Room Elevator Room Equipment Management Office Technology Office Cleaning Tools Room Staff Lounge Changing Shoes Room Wash Hands Toliet Changing Shoes Room Wash Hands Toliet Cleaning Tools Room Auxiliary Room Buffer Room Spray Dryer Room Control Room Buffer Room Buffer Room Buffer Room Secondary Packaging Secondary Packaging Moulds Storage Room Label Storage Room Packaging Material Temporary Storage Temporary Storage Temporary Storage Products Holding Products Holding Temporary Storage Temporary Storage Waste Area Tools Room Spare Room

制药常见词汇英文对照修订稿

保留时间
retention time
氢氧化钠
sodium hydroxide
拆分溶液
Resolution solution
盐酸
hydrochloric acid
水分
water
甲醇
methanol
重金属
Heavy metal
残留溶剂
Residual solvents
流动相
Mobile phase
炽灼残渣
Residue on ignition
柱子
column
含量
Assay
容器
Container
作一个空白对照
Perform a blank determination
剂型
dosage form
鉴别
Identification
规格
strength
熔点
Melting point
适应症
proposed indication
laboratory control record
国家法律
national laws
标准
specifications
注册
registration
主生产文件
master production instructions
人用药
human drug
自检
internal audits self-inspections
清洁程序
cleaning procedures
回风
recirculate
状态
status
管道
pipework
预先计划
established schedule

(中英文)药厂标示标牌功能间名称

（中英文）药厂标示/标牌/功能间名称办公区OFFICE AREA质检部QUALITY TEASTING DEPARTMENT质量部THE QUALITY DEPARTMENT研发部RESEARCH AND DEVELOPMENT DEPARTMENT质控部QUALITY CONTROL DEPARTMENT工程部ENGINEERING DEPARTMENT生产部PRODUCTION DEPARTMENT后勤保障部LOGISTICS DEPARTMENT总经理GENERAL MANAGER业务部THE BUSINESS DEPARTMENT计划部PLANNING DEPARTMENT董事长PRESIDENT秘书SECRETARY党工部THE PARTY AND LABOR UNION DEPARTMENT综合办COMPREHENSIVE OFFICE国际事务部INTERNATIONAL BUSINESS DEPARTMENT会议室MEETING ROOM会客室RECEPTION ROOM餐厅DINING ROOM卫生间TOILET男士GENTELEMEN女士LADIES监控室MONITOR ROOM休息室LOUNGEWORKSHOP 生产车间男更衣室MEN'S CHANGING ROOM 3女更衣室WOMEN'S CHANGING ROOM 3更衣室CHANGING ROOM 1缓冲室BUFFER ROOM 6洗手消毒室HANDS DISINFECTION ROOM 2粉碎过筛室MILLING AND SIEVING ROOM 2称量室WEIGHING ROOM 3制粒室GRANULATING ROOM 1制浆室PASTE PREPARATION 1总混室FINAL BLENDING ROOM 1压片室TABLET COMPRESSING 1工具室TOOL STORAGE 2凉片室TABLET COOLING ROOM 1包衣室TABLET COA TING ROOM 1配浆室COATING MIXTURE PREPARATION 1中间站IN PROCESS STORAGE 1收衣室UNCLEANDED CLOTHES 1洗衣室CLOTHES W ASHING 3整衣室CLOTHES ARRANGING 2内包材暂存室PACKAGING MA TERIAL STORAGE 2容器具清洗室CONTAINER W ASHING 3洁具清洗室CLEANING TOOL WASHING 3容器具烘干室CONTAINER DRYING 1容器具存放室CONTAINER STORAGE 3暂存室TEMPORARY STORAGE 1包材缓冲室PACKAGING MA TERIAL BUFFER ROOM 1 模具室DIES STORAGE 1胶囊填充室CAPSULE FILLING ROOM 1胶囊暂存室CAPSULE STORAGE 1软双铝包装室DOUBLE-ALUMINUM PACKING ROOM 1颗粒包装室GRANULE PACKING ROOM 1塑瓶包装室PLASTIC BOTTLE PACKING 1干燥室DRYING ROOM 1工具存放室TOOL STORAGE 2包衣缓冲室TABLET COA TING BUFFER ROOM 1物料暂存室MATERIAL STORAGE 2物料接收室MATERIAL RECEIVING ROOM 3浸膏粉接收室POWDERED EXTRACT RECEIVING ROOM 1 物料缓冲室MATERIAL BUFFER ROOM 4包装室PACKING ROOM 1检验室TESTING ROOM 2灌封室FILLING & SEALING ROOM液体调配室LIQUOR ROOM 1传递窗TRANSFER WINDOW 12提取室EXTRACTING ROOM 1前处理室PRETREATMENT ROOM 1淋浴SHOWER ROOM 1前室FRONT ROOM 3气闸AIRLOCK ROOM 4阳性对照POSITIVE TEST ROOM 1留样观察室SAMPLES KEEPING ROOM 1拆包间OUTER PACKAGE REMOVING ROOM 3除尘室DUST CHAMBER 3废弃物W ASTE MA TERIAL ROOM 1机械室MECHANICAL ROOM 1标签室LABEL ROOM 1配电室DISTRIBUTION ROOM 3空压机房AIR COMPRESSOR ROOM 1空调机房AIR CONDITIONING ROOM 2纯水室PURIFIED WATER PRODUCTION ROOM 1冷冻机房COOLING ROOM 1消毒清洗室CLEANING & DISINFECTING ROOM 1高温室HIGH TEMPERATURE INSTRUMENT LAB 1稳定性实验室STABILITY TESTING ROOM 1玻璃仪器存放室GLASSW ARE STOREROOM1标准液配制TITRANT & STANDARD SOLUTION试剂存放室REAGENT STOREROOM1天平室BALANCE ANAL YSIS LAB1无菌室STERILIZED ROOM 1微生物培养室MICROCULTURE ROOM 1限度检测室LIMIT DETECTION ROOM 1阳性对照室POSITIVE CONTROL ROOM 1管理资料室REFERENCE ROOM 1留样观察室SAMPLES KEEPING ROOM 1理化检测室PHYSICAL AND CHEMICAL ANAL YSIS ROOM 1 普通仪器室GENERAL INSTRUMENT ROOM1精密仪器实验室PRECISION INSTRUMENT LAB1锅炉房BOILER ROOM 1。

药企中英文标示

药企中英文标示质检办公楼 Quality Control Block董事长 Managing Director总经理 General Manager副总经理 Deputy General Manager副总经理 Deputy General Manager综合办公室 General Office首席药师 Superintendent Pharmacist总工程师 Chief Engineer展览厅 Products Exhibition Hall接待室 Reception Room营销部 Sales Department海外营销部 Export Sales Department会议室 Conference Room财务室 Financial Department消防控制室 Fire Control Room卫生间 Washroom男（含图案） Male女（含图案） Female研发室1 Research & Development Room 1研发室2 Research & Development Room 2中试室 Pilot Study Room普通留样观察室 Long-term Stability Room加速留样观察室 Accelerated Stability Room阴凉留样观察室 Cold Sample Stability Room会议室 Conference Room卫生学实验室准备间 Microbiological Laboratory Preparation Room 卫生学实验室 Microbiological Laboratory高温室 High Temperature Room理化分析室 Physicochemical Analysis Room男更衣室 Men's Changing Room女更衣室 Women's Changing Room天平室 Scales Room气相分析室 Gas Chromatography Room液相分析室 HPLC Room光学分析室 Optical Analysis Room化学试剂储存间 Chemical Reagent Store Room清洗消毒间 Washing and Disinfecting Room清洗间 Cleaning Room空调机房 Air Condition Supply Room安全门 Emergency Exit更衣间 Changing RoomB级气闸 Class B Airlock Room无菌室 Sterilisation Room阳性对照室 Positive Control Room微生物限度检查室 Microbial Limit Testing Room C级走廊 Class C Corridor质量保证部 Quality Assurance Department质控经理 Quality Control Manager倒班宿舍楼 Dormitory Block男卫生间 Washroom Male女卫生间 Washroom Female食堂 Canteen公寓楼 Residential Block女卫生间 Washroom Female男卫生间 Washroom Male活动室 Recreation Center制剂楼 Production Block机修配件室 Mechanical Hardware Warehouse 操作室 Operating Room锅炉房 Boiler Room配电室 Electricity Distribution Room机房 Machinery Room机房 Machinery Room安全出口 Emergency Exit制水间 Water Treatment Plant库区办公室 Storage Area Office特殊原料库 Special Raw Materials Store原料库1 Raw Materials Store 1原料库2 Raw Materials Store 2标签存放室 Label Storage Room不合格品库 Unqualified Products Store冷库 Cold Storeroom阴凉库 Cool Storeroom卫生间 Washroom男（含图标） Male女（含图标） Female生产经理 Production Manager车间管理 Workshop Management工衣整理间 Clothing Arrangement Room工衣清洗间 Clothing Washing Room男更 Change Room Male女更 Change Room Female女淋浴间 Female showering男淋浴间 male showering取样间 Sampling Room更衣间 Change Room取样室 Sampling Room气闸 Airlock活性炭称量 AC Weighing Room消毒液配置 Disinfectant Solution Preparation Room原料暂存间 Raw Material Temporary Store Room男更 Change Room Male女更 Change Room Female气闸 Airlock工衣整理 Clothing Arrangement Room工衣清洗消毒 Clothes Washing and Disinfecting Room容器具清洗 Container Cleaning Room容器具消毒 Container Sterilization Room疏散门 Emergency Exit清洗间 Cleaning Room洁具间 Cleaning Tools Room清洁间 Cleaning Room物净室 Material Cleaning Room气闸室 Airlock Room称量间 Weighing Room模具间 Tools Room浓配间 Concentrated Solution Preparation Room稀配间 Dilute Solution Preparation Room中检室 In-process Control Lab包材暂存间 Packaging Material Temporary Storage Room 废品暂存间 Wastes Temporary Store Room废品处理间 Waste Disposal Room灌封间 Filling and Sealing Section缓冲间 Buffer Room灭菌前室 Pre-Sterilization Room灭菌后室 Post-Sterilization Room灭菌机房 Sterilization Equipment Room灭菌控制室 Sterilization Control Room灯检室 Visual Examination Room包装间 Packaging Section原料库 Raw Materials Store成品库 Finished Products Store不合格品室 Temporary Rejected Products Store Room标签暂存 Temporary Label Store room货流出口 Logistics Exit货流入口 Logistics Entrance包材区 Packing Materials Area成品区 Finished Products Area成品暂存区 Quarantined Finished Products Area退货暂存区 Returned Products Area外包材暂存区 Quarantined Outpackage Materials Area 门房 Security Room。

药厂功能间中英文对照

20*7
ZJ1106
ArchiveRoom
收样室
1
个
23*9.5
20*7
ZJ1107
SamplesCollectionRoom
理化室
1
个
23*9.5
20*7
ZJ1108
PhysicalandChemicalAnalysisRoom
仪器一室
1
个
23*9.5
20*7
ZJ1109
InstrumentsRoom1
常温留样室
1
个
23*9.5
20*7
ZJ1114
RetainedSamplesRoom(Ambient)
阴凉留样室
1
个
23*9.5
20*7
ZJ1115
RetainedSamplesRoom(Cool)
培养室
1
个
23*9.5
20*7
ZJ1116
CultivatingRoom
仪器三室
1
个
23*9.5
20*7
ZJ1117
InstrumentsRoom3
仪器四室
1
个
23*9.5
20*7
ZJ1118
InstrumentsRoom4
天平室
1
个
23*9.5
20*7
ZJ1119
BalancesRoom
走廊
1
个
23*9.5
20*7
ZJ1120
Corridor
缓冲
6
个
23*9.5
20*7
ZJ1121、ZJ1131、ZJ1132、ZJ1137、CK1117、CK1122

药厂房间名称中英文

药厂房间编号-中英文编号房间翻译级别R001 换鞋间Changing Shoes 一般R002 男更衣间Men’s changing room 一般R003 女更衣间Women’s changing room 一般R004 缓冲Buffer 一般R005 洗衣间Laundry Room 一般R006 洁具间Sanitary ware Room 一般R007 变配电站transformer and distribution power station 一般R008 女厕Women’s Room 一般R009 男厕Men’s Room 一般R010 收发区Sending and Receiving Area 一般R011 综合仓库区Composite Depository 一般R012 阴凉库1 Shady Depository 1 一般R013 阴凉库2 Shady Depository 2 一般R014 不合格品库Reject Depository 一般R015 纯化水站Purified Water 一般R016 仓库办公室Depository Office 一般R017 男洗手间Men’s Room 一般R101 换鞋间Changing Shores 一般R102 男脱外衣Men’s Coat off 一般R103 男穿工衣Men wear work cloth CR104 女脱外衣Women’s Coat off 一般R105 女穿工衣Women wear work cloth CR106 手消间Hands Disinfection CR107 洁净走廊Clean Corridor CR108 洗衣间Laundry Room CR109 理衣间Collation Clothes room C+A R110 洁具间Sanitary ware Room CR111 器具存放Storing Appliance CR112 铝盖清外包Taking off Aluminium cap’s Cover 一般R113 铝盖暂存Scratching Aluminium cap CR114 铝盖消毒处理Aluminium cap Disinfection CR115 消毒铝盖暂存Scratching Disinfected Aluminium cap C+A R116 轧盖前室Capping Lobby CR117 轧盖间Capping Room CR118 外包缓冲Cover Buffer 一般R119 清洗间Cleaning Room CR120 废弃物暂存缓冲Scratching Waste Buffer CR121 废弃物暂存Scratching Waste 一般R122 待清洗物暂存Scratching awaiting cleaning matter CR123 消毒液配制Disinfecting Fluid Preparation CR124 消毒液过滤Filtering Disinfecting Fluid CR125 原料包装物表面消毒Disinfecting Surface CR126 原料气闸Raw Material’s pneumatic brake CR127 原料清外包Taking off Raw Material’s Cover 一般R201 换鞋间Changing Shores CR202 脱工衣Taking off work cloth CR203 穿无菌内衣Wearing Sterile Underwear BR204 穿无菌外衣Wearing Sterile coat BR205 手消间Hands Disinfection BR206 B级洁净走廊Clean Corridor B BR207 退出缓冲间Quitting Buffer BR208 脱无菌衣Taking off Sterile cloth BR209 消毒液接受Receiving Disinfecting Fluid BR210 原料暂存Scratching Raw material BR211 取样间Sampling Room B+A R212 称量间Weighing Room B+A R213 除尘间Removing Dust 一般R214 混合间Mixing Room B+A R215 分装前室Split Charging Lobby BR216 分装间Split Charging Room B+A R217 质控间Quality Control Room B+A R218 待清洗物缓冲awaiting cleaning matter Buffer BR219 灭菌后存放Storing after sterilization BR301 换鞋间Changing Shores 一般R302 脱外衣Taking off coats 一般R303 穿工衣Wearing work cloth D R304 手消间Hands Disinfection D R305 洗衣间Laundry Room D R306 洁具间Sanitary ware Room D R307 器具暂存间Scratching Appliance D R308 清洗间Cleaning Room D R309 西林瓶、胶塞清洗灭菌Washing, Sterilizing D R310 胶塞暂存间Scratching rubber plug D R311 胶塞清外包Taking off rubber plug’s Cover 一般R312 理瓶间Collation vial room 一般R313 西林瓶、胶塞暂存Scratching vial and rubber plug 一般R314 外包装区external packing area 一般R315 标签管理Label Management 一般R316 洁具间Sanitary ware Room 一般R601 车间办公室Workshop Office 一般R602 饮水间Drinking Room 一般R603 洁具间Sanitary ware Room 一般R604 空调机房 1 Air-conditioner Room 1 一般R605 机修间Machine repaired Room 一般R606 空调机房 2 Air-conditioner Room 2 一般R607 冷冻水Frozen Water 一般R608 注射用水Water for Injection 一般R609 空压、真空机房Vacuum Room 一般R402 脱外衣Taking off coats 一般R403 穿工衣Wearing work cloth C R404 缓冲1 Buffer 1 C R405 微生物限度检测室Microbial Limit Tested Room C R406 缓冲2 Buffer 2 C R407 无菌室1（左）Sterile Room 1 C R408 无菌室2（右）Sterile Room 2 C R409 缓冲Buffer 一般R501 换鞋Changing Shores 一般R502 脱外衣Taking off coats 一般R503 穿工衣Wearing work cloth C。

（中英文）药厂标示标牌功能间名称

（中英文）药厂标示标牌功能间名称第一篇：(中英文)药厂标示标牌功能间名称（中英文）药厂标示/标牌/功能间名称办公区 OFFICE AREA 质检部QUALITY TEASTING DEPARTMENT 质量部THE QUALITY DEPARTMENT 研发部RESEARCH AND DEVELOPMENT DEPARTMENT 质控部QUALITY CONTROL DEPARTMENT 工程部ENGINEERING DEPARTMENT 生产部PRODUCTION DEPARTMENT 后勤保障部LOGISTICS DEPARTMENT 总经理GENERAL MANAGER 业务部THE BUSINESS DEPARTMENT 计划部PLANNING DEPARTMENT 董事长PRESIDENT 秘书SECRETARY 党工部THE PARTY AND LABOR UNION DEPARTMENT 综合办COMPREHENSIVE OFFICE 国际事务部INTERNATIONAL BUSINESS DEPARTMENT 会议室MEETING ROOM 会客室RECEPTION ROOM 餐厅DINING ROOM 卫生间TOILET男士GENTELEMEN女士LADIES监控室MONITOR ROOM 休息室LOUNGEWORKSHOP 生产车间男更衣室MEN'S CHANGING ROOM 3 女更衣室WOMEN'S CHANGING ROOM 3 更衣室CHANGING ROOM 1 缓冲室BUFFER ROOM 6洗手消毒室HANDS DISINFECTION ROOM 2 粉碎过筛室MILLING AND SIEVING ROOM 2 称量室WEIGHING ROOM 3 制粒室GRANULATING ROOM 1 制浆室PASTE PREPARATION 总混室FINAL BLENDING ROOM 1 压片室TABLET COMPRESSING 1 工具室TOOL STORAGE 2凉片室TABLET COOLING ROOM包衣室TABLET COATING ROOM 1配浆室COATING MIXTURE PREPARATION 1 中间站IN PROCESS STORAGE 1 收衣室UNCLEANDED CLOTHES 1 洗衣室CLOTHES WASHING整衣室CLOTHES ARRANGING 2内包材暂存室PACKAGING MATERIAL STORAGE容器具清洗室CONTAINER WASHING 3洁具清洗室CLEANING TOOL WASHING 容器具烘干室容器具存放室暂存室包材缓冲室模具室胶囊填充室胶囊暂存室软双铝包装室颗粒包装室塑瓶包装室干燥室工具存放室包衣缓冲室物料暂存室物料接收室浸膏粉接收室物料缓冲室包装室检验室灌封室液体调配室传递窗提取室前处理室淋浴前室气闸阳性对照留样观察室拆包间除尘室废弃物机械室标签室配电室CONTAINER DRYING 1 CONTAINER STORAGE 3 TEMPORARY STORAGE 1PACKAGING MATERIAL BUFFER ROOM 1 DIES STORAGE 1CAPSULE FILLING ROOMCAPSULE STORAGEDOUBLE-ALUMINUM PACKING ROOM 1 GRANULE PACKING ROOM 1 PLASTIC BOTTLE PACKING 1 DRYING ROOM 1 TOOL STORAGETABLET COATING BUFFER ROOM 1 MATERIAL STORAGE 2MATERIAL RECEIVING ROOM 3POWDERED EXTRACT RECEIVING ROOM 1 MATERIAL BUFFER ROOM 4 PACKING ROOM 1 TESTING ROOM 2 FILLING & SEALING ROOM LIQUOR ROOM 1TRANSFER WINDOW 12EXTRACTING ROOM PRETREATMENT ROOM 1 SHOWER ROOM 1 FRONT ROOM 3 AIRLOCK ROOM 4POSITIVE TEST ROOM 1 SAMPLES KEEPING ROOM 1OUTER PACKAGE REMOVING ROOM 3 DUST CHAMBER 3WASTE MATERIAL ROOM 1 MECHANICAL ROOM 1 LABEL ROOM 1DISTRIBUTION ROOM 3空压机房AIR COMPRESSOR ROOM 1 空调机房AIR CONDITIONING ROOM 2 纯水室PURIFIED WATER PRODUCTION ROOM 1 冷冻机房COOLING ROOM 1 消毒清洗室CLEANING & DISINFECTING ROOM高温室HIGH TEMPERATURE INSTRUMENT LAB 1 稳定性实验室STABILITY TESTING ROOM 1 玻璃仪器存放室GLASSWARE STOREROOM1 标准液配制TITRANT & STANDARD SOLUTION 试剂存放室天平室无菌室微生物培养室限度检测室阳性对照室管理资料室留样观察室理化检测室普通仪器室精密仪器实验室锅炉房REAGENT STOREROOM1 BALANCE ANALYSIS LAB1 STERILIZED ROOM 1MICROCULTURE ROOM 1 LIMIT DETECTION ROOM 1 POSITIVE CONTROL ROOM 1 REFERENCE ROOM 1SAMPLES KEEPING ROOM 1PHYSICAL AND CHEMICAL ANALYSIS ROOM GENERAL INSTRUMENT ROOM1 PRECISION INSTRUMENT LAB1 BOILER ROOM 1第二篇：道路名称标示规范道路名称标示规范根据《广东省地名管理条例》的有关规定，结合我市的具体实际，为规范我市地名工作管理，特制定我市的道路名称标示规范。

药厂功能间中英文对照

TemporaryStorageRoom
5
洁具存放室
1
个
23*9.5
20*7
SanitaryApplianceStorageRoom
6
外包材暂存室
1
个
23*9.5
20*7
TemporaryStorageRoomforPackagMaterials
7
缓冲室
2
个
23*9.5
20*7
BufferRoom
8
20*7
CK2304
北面走廊东
1
个
23*9.5
20*7
CK2305
仓库灭蝇灯编号
灭蝇灯(走廊)
1
个
23*9.5
20*7
CK1701
质量控制部功能间标牌定做清单
房间名称
数量
单位
字牌尺寸
字体大小
房间编号
英文名称
备注
总更
1
个
23*9.5
20*7
ZJ1101
DressingRoom
稳定性考察室
1
个
23*9.5
20*7
ZJ1106
ArchiveRoom
收样室
1
个
23*9.5
20*7
ZJ1107
SamplesCollectionRoom
理化室
1
个
23*9.5
20*7
ZJ1108
PhysicalandChemicalAnalysisRoom
仪器一室
1
个
23*9.5
20*7
ZJ1109
InstrumentsRoom1
20*7

制药行业常用英语(中英文对照版)

制药行业常用英语1、药品生产质量管理规范GMP：Good ManufacturingPractice2、国家食品与药品监督管理局State Food andDrug Administration3、总则GeneralProvisions4、《中华人民共和国药品管理法》the DrugAdministration Law of the People's Republic of China 5、制剂Preparation6、原料药API: Active PharmaceuticalIngredient7、成品finished goods8、工序process9、机构与人员organization and personnel10、专业知识professional knowledge11、生产经验production experience12、组织能力organizational skill13、技术人员technical staff14、实施implementation15、药品生产pharmaceutical manufacturing 16、质量管理quality management17、质量检验quality inspection18、专业技术培训professional and technicaltraining 19、基础理论知识basic theoreticalknowledge20、实际操作技能practical operationskills 21、高生物活性highly potent22、高毒性high toxicity23、污染contamination24、考核评估assessment25、厂房与设施buildings and facilities 26、生产环境production environment 27、空气洁净级别clean air level28、昆虫insect29、洁净室（区）clean room(area)30、光滑smooth31、无裂缝no cracks32、无颗粒物脱落no particle shedding 33、耐受endure34、消毒disinfection35、无菌sterile36、交界处junction, joint37、弧形arc38、灰尘积聚dues accumulation 39、储存区store area40、生产规模production scale 41、设备equipment42、物料material43、中间产品intermediate product 44、待验品quarantined material 45、交叉污染cross-contamination 46、管道pipeline, ductwork 47、风口tuber48、公用设施, 公用工程utilities of publicservice 49、照明lighting50、照度illumination51、应急紧急情况emergency52、净化purification, clean53、微生物, 微生物学, 微生物的micro-organism, microbiology,microbiologic 54、监测monitoring55、记录record56、天棚天花板ceiling, roof57、密封seal58、静压差Static DifferentialPressure 59、温度temperature60、相对湿度RH: Relative Humidity 61、低漏地漏floor drainer62、青霉素penicillin63、分装室separating room, fillingroom64、相对负压relative negativepressure65、废气waste gas,exhausted air66、β－内酰胺结构类药品β-Lactasestructure drug, drugs of β-Lactic group67、避孕药品contraceptives68、激素类hormone69、抗肿瘤类anti-tumor, oncology70、放射性药品Radiopharmaceuticals71、包装packing, package72、循环使用recycling73、微粒particles74、辐射radiation, irradiation75、细菌bacteria76、病毒virus77、细胞cell78、脱毒前后pre and post detoxification 79、活疫苗与灭活疫苗active vaccine/inactivatedvaccine 80、人血液制品blood products 81、预防制品prevention products82、灌装filling83、中药Chinesetraditional medicines 84、前处理pretreatment85、提取extraction86、浓缩concentration87、动物脏器viscera of animal,organ of animal 88、蒸、炒、炙、煅steaming, frying,sunburn, testing 89、炮制concocted90、通风ventilation91、除烟smoke removal92、除尘dust removal93、降温设施temperature-reducingestablishment, cooling94、筛选screening, sift95、切片slicing96、粉碎grinding97、压缩空气compressed air98、惰性气体noble gas99、取样Sampling100、称量室weighing room, dispensingroom 101、中药标本Chinese herbal sample,exemplar of TCM 102、检定鉴定verification, identification 103、同位素Isotope104、设备equipment105、选型model/type selection 106、耐腐蚀anticorrosion107、吸附adsorption, absorption 108、润滑剂, 润滑lubricant, lubricate 109、冷却剂coolant110、流向flow direction111、纯化水PW: Purified Water 112、注射用水WFI: Water for Injection 113、滋生breeding114、储罐tank115、死角neglected portion 116、盲管blind pipe117、纤维fiber118、疏水性hydrophobicity119、仪表instrumentation 120、量具measuring tool 121、衡器weighing instrument 122、精密度precision123、维修、保养maintenance 124、不合格disqualified reject 125、物料material126、购买purchasing127、发放releasing128、产地origin129、入库loading130、固体solid131、液体liquid132、挥发性volatile133、净药材net medicine, netTCM 134、麻醉药品narcotics135、精神药品psychotropic drug 136、易燃combustible137、易爆explosive138、验收acceptance139、使用说明书instruction140、标签label 141、卫生, 清洁/消毒sanitation142、车间, 辅房workshop143、间隔时间time interval144、清洁剂detergent145、消毒剂disinfectant146、废弃物wastes147、更衣室changing room148、工作服,work clothes149、颗粒性物质, 颗粒剂granules150、耐药菌株drug-resistant strain151、传染病infectiousdisease152、皮肤病dermatitis153、验证verification, validation 154、确认qualification155、安装installation156、运行running operation 157、性能performance158、原辅料raw material and incipient 159、文件document160、投诉complaint 161、报废reject162、品名product name163、处方preion, formula164、技术参数technicalparameter165、容器container166、半成品semi-finished product,intermediate167、申请application168、稳定性stability169、起草draft170、生产管理production management,manufacturing control.171、事故accident172、混淆mix-up173、喷雾spray174、合格证certificate175、清场clearance176、质量管理quality management 177、内控internal control,on-line test 178、滴定液tartan179、培养基medium180、有效期validity, expiry date,shelf life 181、产品销售与收回product sales andrecovery/recall 182、投诉与不良反应报告complaints and adversereaction 183、自检self-inspection184、附则schedule appendix185、平衡balance186、饮用水drinking water, potablewater 187、蒸馏法distillation188、离子交换法ion exchange189、反渗透法RO: Reverse Osmosis190、附加剂添加剂additives191、滞留stranded resort192、批batch, lot193、组分, 组成component194、无纤维脱落的过滤器non-fiber-releasingfilter195、活性成份Active Ingredient196、非活性成份Inactive ingredient197、中间产品in-process product,intermediate product 198、批号batch number199、药用物料medicated feed200、药用预混合料medicated premix 201、质量控制部门Quality control department 202、理论产量Theoretical yield203、实际产量Actual yield204、比率Percentage, rate205、验收标准可接受标准Acceptance criteria206、代表性样品Representative sample 207、微粒状的particulate208、污染物contaminant209、石棉asbestos210、诊断diagnosis211、缓解mitigation212、化学变化chemical change 213、组分ingredient, component 214、制备fabricate preparation 215、复合compound216、混合blend217、加工processing218、浓度concentration219、单位剂量unit dose220、药品包装容器drug product containers 221、密封件, 封盖closure222、效价Titer223、纯度purity224、规格strength225、监督supervise, monitor226、实验室laboratory227、无菌操作aseptic operation,sterile operation 228、层流laminar flow229、湍流turbulent air flow230、空气过滤air filtration231、空气加热air heating 232、预过滤器profiler233、排气系统exhaust system 234、管件plumbing 235、虹吸倒流back-siphon age 236、污水sewage237、废料refuse238、盥洗设备toilet facilities 239、空气干燥器air drier240、垃圾trash 241、有机废料organic waste242、杀鼠剂rodenticides243、杀昆虫剂insecticides244、杀真菌剂fungicides245、熏蒸剂fumigating reagents246、去垢剂cleaning agents247、消毒剂sanitizing agents248、滂沱剂lubricant249、自动化设备、机械化设备和电子设备automatic, mechanical,or electronic equipment 250、微型胶卷microfilm251、注射剂injection252、灭菌设备sterilization equipment 253、无菌取样技术aseptic sampling techniques 254、显微镜microscope255、热源, 内毒素pyrogen, endotoxin256、偏差deviation257、变更change control258、进料charge-in259、项目代码item code260、鉴别identify 261、片剂tablet262、胶囊capsule263、颗粒剂granule264、溶解时间溶出时间dissolution time265、澄明度clarity266、隔离系统quarantinesystem, isolation system 267、返工reprocessing268、发放issuance, release269、非处方药OTC:over-the-counter270、处方药preed medicine271、皮肤科药、牙粉、胰岛素、喉片dermatological, dentifrice,insulin, or throat lozenge product272、保险包装tamper-resistant package273、明胶硬胶囊hard gelatin capsule274、顺势治疗homeopathic275、入库warehousing276、变质deteriorate277、准确性accuracy278、灵敏性sensitivity279、特异性specificity280、重复性reproducibility, repeatability 281、变应原提取物allergenic extracts282、眼膏ophthalmic ointment283、粗糙或磨蚀物质harsh or abrasivesubstances 284、控释制剂controlled-releasedosage form 285、实验动物laboratory animals286、供应商Supplier287、光谱spectrum288、测量单位units of measure289、换算系数conversion factors290、试剂reagent291、安慰剂placebo292、明确地explicitly293、取代supersede294、溶液solution295、批准approval296、(美国)食品药品监督管理局FDA: Food and DrugAdministration 297、标准操作程序SOP: Standard OperatingProcedure 298、质量保证QA: Quality Assurance299、质量控制QC:Quality Control300、批生产记录BPR: Batch ProductionRecord 301、批检验记录BAR: Batch AnalysisRecord302、工艺规程PP: Process Procedure303、健康,安全,环保EHS: Environment,Health and Safe 304、美国联邦法规CFR: Code of FederalRegulation 305、美国药典USP: The United StatesPharmacopeia 306、欧洲药典EP: European pharmacopeia307、英国药典BP: British pharmacopeia308、药物主文件DMF: Drug Master File309、验证主计划VMP: Validation MasterPlan310、验证方案VP: Validation Protocol311、验证报告VR: Validation Report312、安装确认IQ: Installation Qualification 313、运行确认OQ: Operation Qualification 314、性能确认PQ: Performance Qualification 315、超出标准(限度)OOS: Out of Specification 316、冻干产品freeze-dry product,lyophilizated product317、工厂主述文件SMF: Site Master File。

制药行业术语中英文对照

术语表Acceptance Criteria–接受标准:接受测试结果的数字限度、范围或其他合适的量度标准。

此种物质在疾病的诊断，治疗，症状缓解，处理或疾病的预防中有药理活性或其他直接作用，或者能影响机体的功能和结构。

API Starting Material–原料药的起始物料:用在原料药生产中的，以主要结构单元被并入该原料药的原料、中间体或原料药。

原料药的起始物料可能是在市场上有售，能够根据合同或商业协议从一个或多个供应商处购得，或者自己生产。

原料药的起始物料通常有特定的化学特性和结构。

Batch（or Lot）-批:有一个或一系列工艺过程生产的一定数量的物料，因此在规定的限度内是均一的。

在连续生产中，一批可能对应与生产的某以特定部分。

其批量可规定为一个固定数量，或在固定时间间隔内生产的数量。

Batch Number（or Lot Number）-批号用于标识一批的一个数字、字母和/或符号的唯一组合，从中可确定生产和销售的历史。

Bioburden–生物负载：可能存在与原料、原料药的起始物料、中间体或原料药中的微生物的水平和种类（例如，治病的或不治病的）。

生物负载不应当当作污染，除非含量超标，或者测得治病生物。

Calibration–校验：证明某个仪器或装置在一适当的量程范围内测得的结果与一参照物，或可追溯的标准相比在规定限度内。

Computer System–计算机系统：设计安装用于执行某一项或一组功能的一组硬件元件和关联的软件。

Computerized System–计算机化系统与计算机系统整合的一个工艺或操作。

Contamination–污染：在生产、取样、包装或重新包装、贮存或运输过程中，具化学或微生物性质的杂质或外来物质进入或沾染原料、中间体或原料药。