生产工艺常用词汇：
中文英文
单硫酸卡那霉素Kanamycin sulfate
硫酸氢钠sodium bisulfate
枸橼酸钠sodium citrate
硫酸溶液Sulfuric acid solution
中性硼玻璃安瓿瓶Neutral borosilicate glass ampoule
安瓿瓶清洗Ampoule washing
安瓿瓶灭菌除热源Ampoule sterilization and depyrogenation
配料Batching
过滤Filtration
灌封Filling and sealing
灭菌和检漏测试Sterilization and leakage test
灯检Visual / Lamp inspection
贴签和包装Labeling and packaging
关键工艺参数Critical Process Parameter
升温段heating section
传送带conveyor belt
压差Differential pressure
时间间隔Time interval
过滤器孔径Pore size of filter
过滤压力Filtration pressure
灌装量Filling volume
缓冲罐buffer tank
灌装前充氮保护pre-filling nitrogen flush
灌装后充氮保护post-filling nitrogen overlay
真空检漏测试Vacuum leak test
内包材Primary packaging material
Process instruction
Livzon Group Fuzhou Fuxing
Pharmaceutical Co. Ltd.
Hunan Erkang Pharmaceutical Co., Ltd
Hunan Huari Pharmaceutical Co., Ltd
Guangzhou Chemical Reagent Factory
Zhuhai Da Lin Wan Industrial Gas Co., Ltd
SCHOTT Glass Technologies (Suzhou) Co.
Ltd
quality specification
Circulation water
Rotating speed
QC常用英文词汇
中文英文
物理性状Physical attributes
外观Appearance
不溶性微粒Particulate matter
溶液颜色Solution color
鉴别Identification
保留时间retention time
含量Assay
有关物质Related substance
标示量labeled amount
可见异物Visible particles
无菌Sterility
薄膜过滤法Membrane filtration method
内毒素Bacterial endotoxins
Initial bioburden
stirring uniformity
ashy top
pointed end
bubble head, flat head, broken ampoule,
crooked ampoule, empty ampoule;
中文英文
药品生产质量管理规范GMP: Good Manufacturing Practice
国家食品与药品监督管理局State Food and Drug Administration
总则General Provisions
制剂preparation
原料药API: Active Pharmaceutical Ingredient
成品finished goods
工序process
机构与人员organization and personnel
专业知识professional knowledge
生产经验production experience
组织能力organizational skill
技术人员technical staff
实施implementation
药品生产pharmaceutical manufacturing
质量管理quality management
质量检验quality inspection
专业技术培训professional and technical training 基础理论知识basic theoretical knowledge
实际操作技能practical operation skills
高生物活性highly potent
高毒性high toxicity
污染contamination
考核评估assessment
厂房与设施buildings and facilities
生产环境production environment
空气洁净级别clean air level
昆虫insect
洁净室（区）clean room(area)
光滑smooth
无裂缝no cracks
无颗粒物脱落no particle shedding
耐受tolerance
消毒disinfection
无菌sterile
交界处junction, joint
弧形arc
灰尘积聚dust accumulation
储存区store area
生产规模production scale
设备equipment
物料material
中间产品intermediate product
待验品quarantined material
交叉污染cross-contamination
管道pipeline
公用设施utilities of public service
照明lighting
照度illumination
应急,紧急情况emergency
净化purification, clean
微生物, 微生物学, 微生物的micro-organism, microbiology, microbiologic 监测monitoring
记录record
天棚天花板ceiling, roof
密封seal
静压差Static Differential Pressure
温度temperature
相对湿度RH: Relative Humidity
地漏floor drainer
分装室separating room, filling room
相对负压relative negative pressure
废气waste gas, exhausted air
β－内酰胺结构类药品β-Lactams structure drug
避孕药品contraceptives
激素类hormone
抗肿瘤类anti-tumor, oncology
放射性药品Radiopharmaceuticals
包装packing, package
循环使用recycling
微粒particles
辐射radiation
细菌bacteria
病毒virus
细胞cell
脱毒前后Pre-detoxification and post detoxification 活疫苗与灭活疫苗active vaccine/inactivated vaccine
人血液制品blood products
预防制品prevention products
灌装filling
中药Chinese traditional medicines
前处理pretreatment
提取extraction
浓缩concentration
动物脏器viscera of animal, organ of animal
炮制concocted
通风ventilation
除烟smoke removal
除尘dust removal
降温设施temperature-reducing establishment, cooling 筛选screening
切片slicing
粉碎grinding
压缩空气compressed air
惰性气体noble gas
取样sampling
称量室weighing room
中药标本Chinese herbal sample, exemplar of TCM
检定鉴定verification, identification
同位素Isotope
设备equipment
选型model/type selection
耐腐蚀anticorrosion
吸附adsorption, absorption
润滑剂, 润滑lubricant, lubricate
冷却剂coolant
流向flow direction
纯化水PW: Purified Water
注射用水WFI: Water for Injection
滋生breeding
储罐tank
死角neglected portion
盲管blind pipe
纤维fiber
疏水性hydrophobicity
仪表instrumentation
量具measuring tool
衡器weighing instrument
精密度precision
维修、保养maintenance
不合格disqualified
物料material
购买purchasing
发放releasing
产地origin
固体solid
液体liquid
挥发性volatile
净药材net medicine, net TCM
麻醉药品narcotics
精神药品psychotropic drug
易燃combustible
易爆explosive
验收acceptance
使用说明书instruction
标签label
卫生hygiene
车间workshop
间隔时间time interval
清洁剂detergent
消毒剂disinfectant
废弃物wastes
更衣室changing room
工作服,work clothes
颗粒性物质, 颗粒剂granules
耐药菌株drug-resistant strain
传染病infectious disease
皮肤病dermatosis
验证verification, validation 确认qualification
安装installation
运行running operation
性能performance
原辅料raw material and excipient
文件document
投诉complaint
报废reject
品名product name
处方prescription, formula
技术参数technical parameter
容器container
申请application
稳定性stability
起草draft
生产管理production management, manufacturing control.混淆mix-up
喷雾spray
合格证certificate
清场clearance
质量管理quality management
内控internal control
滴定液titrant
培养基medium
有效期validity, expiry date, shelf life
产品销售与收回product sales and recall
投诉与不良反应报告complaints and adverse reaction report
自检self-inspection
附则appendix
平衡balance
饮用水drinking water
蒸馏法distillation
离子交换法ion exchange
反渗透法RO: Reverse Osmosis
附加剂添加剂additives
滞留stranded resort
批batch, lot
组分, 组成component
无纤维脱落的过滤器non-fiber-releasing filter
活性成份Active Ingredient
非活性成份Inactive ingredient
中间产品intermediate product
批号batch number
药用物料medicated feed
药用预混合料medicated premix
质量控制部门Quality control department
理论产量Theoretical yield
实际产量Actual yield
比率Percentage, rate
验收标准可接受标准Acceptance criteria
代表性样品Representative sample
微粒状的particulate
污染物contaminant
石棉asbestos
诊断diagnosis
缓解mitigation
化学变化chemical change
组分ingredient, component
制备fabricate preparation
复合compound
混合blend
加工processing
浓度concentration
单位剂量unit dose
药品包装容器drug product containers
密封件, 封盖closure
效价titer
纯度purity
规格strength
监督supervise, monitor
实验室laboratory
无菌操作aseptic operation, sterile operation
层流laminar flow
湍流turbulent air flow
空气过滤air filtration
空气加热air heating
预过滤器Pre-filter
排气系统exhaust system
管件plumbing
污水sewage
废料refuse
空气干燥器air drier
垃圾trash
有机废料organic waste
杀鼠剂rodenticides
杀昆虫剂insecticides
杀真菌剂fungicides
熏蒸剂fumigating reagents
去垢剂cleaning agents
消毒剂sanitizing agents
滂沱剂lubricant
自动化设备、机械化设备和电子设
automatic, mechanical, or electronic equipment 备
微型胶卷microfilm
注射剂injection
灭菌设备sterilization equipment
无菌取样技术aseptic sampling techniques
显微镜microscope
热源, 内毒素pyrogen, endotoxin
偏差deviation
变更change control
进料charge-in
项目代码item code
鉴别identify
片剂tablet
胶囊capsule
颗粒剂granule
溶解时间dissolution time
澄明度clarity
隔离系统isolation system
返工reprocessing
发放issuance, release
非处方药OTC: over-the-counter
处方药prescription medicine
保险包装tamper-resistant package
明胶硬胶囊hard gelatin capsule
顺势治疗homeopathic
入库warehousing
变质deteriorate
准确性accuracy
灵敏性sensitivity
特异性specificity
重复性reproducibility, repeatability
变应原提取物allergenic extracts
眼膏ophthalmic ointment
粗糙或磨蚀物质harsh or abrasive substances
控释制剂controlled-release dosage form
实验动物laboratory animals
供应商supplier
光谱spectrum
测量单位units of measure
换算系数conversion factors
试剂reagent
安慰剂placebo
明确地explicitly
取代supersede
溶液solution
批准approval
(美国)食品药品监督管理局FDA: Food and Drug Administration 标准操作程序SOP: Standard Operating Procedure 质量保证QA: Quality Assurance
质量控制QC: Quality Control
批生产记录BPR: Batch Production Record
批检验记录BAR: Batch Analysis Record
工艺规程PP: Process Procedure
健康,安全,环保EHS: Environment, Health and Safe
美国联邦法规CFR: Code of Federal Regulation
美国药典USP: The United States Pharmacopeia
欧洲药典EP: European pharmacopeia
英国药典BP: British pharmacopeia
药物主文件DMF: Drug Master File
验证主计划VMP: Validation Master Plan
验证方案VP: Validation Protocol
验证报告VR: Validation Report
安装确认IQ: Installation Qualification
运行确认OQ: Operation Qualification
性能确认PQ: Performance Qualification
超出标准(限度)OOS: Out of Specification
冻干产品freeze-dry product, lyophilized product 工厂主述文件SMF: Site Master File