GMP常用英语单词
Abbreviated New drug
简化申请的新药Accelerated approval
加速批准Adverse effcet
副作用Adverse reaction
不良反应Agency
审理部门ANDA(Abbreviated New drug application)简化新药申请Animal trial
动物试验Archival copy
存档用副本Batch production records
生产批号记录Batch production
批量生产CFR （Code of federal regulation ）(美)联邦法规Clinical trial
临床试验COS/CEP
欧洲药典符合性认证Dietary supplement
食品补充品DMF(Drug master file)
药物主文件Drug substance
原料药Generic name
非专利名称ICH(International Conference on
Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use)
人用药物注册技术要求国际协调会议IND(Investigation new drug)
临床研究申请（指申报阶段，相对于NDA）；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）Informed consent
知情同意INN(international nonproprietary name)国际非专有名称Investigator
研究人员；调研人员Labeled amount
标示量NDA(New drug application)
新药申请NF(National formulary)
(美)国家药品集NIH(National Institute of Health)(美)国家卫生研究所Panel
专家小组preparing and Submitting
起草和申报Prescription drug
处方药Proprietary name
专有名称Regulatory methodology
质量管理方法Regulatory methods validation
管理用分析方法的验证Regulatory specification
质量管理规格标准Review copy
审查用副本Sponsor
主办者（指负责并着手临床研究者）Standard drug
标准药物Strength
规格；规格含量（每一剂量所含有效成分的量）Submission
申报；递交Treatment IND
研究中的新药用于治疗生产工艺相关
Acceptance criteria
可接受标准air driers
手烘箱Airlock Room
气闸室analytical methods
分析方法anhydrous
无水API
原料药Assay 含量
at rest静态
batch size批量
Blending Batches混批
Blending Room总混间
calibrating校正
case-by-case具体分析
centigrate摄氏度
Changing Room更衣室
Charge-in进料
chemical properties化学性质
Clarity,completeness,or PH of solutions溶液的澄明度、溶解完全性及PH值cleaning agents清洗媒介
cleaning procedures清洁程序
Cleaning Tools Room洁具室
Coating Mixture Preparing Room配浆间
Commercial scale可配伍性
Concentrated Solution Room浓配室
consistency of the process工艺的稳定性
critical process关键步骤
dedicated专用的
Documentation System文件系统
dosage form剂型
electronic form电子格式
electronicsignatures电子签名
Emergency Door安全门
established schedule预先计划
Excipient辅料
exhaust排气
fermentation发酵
Granulation颗粒
HAVC(Heating ventilation and air conditioning)空调净化系统
Heavy metal重金属
historical date历史数据Hydrochloric acid盐酸
in operation动态
incoming materials进厂物料
in-house testing内控检测installation qualification(IQ)安装确认intermediate中间体
intermal audits self-inspection自检
laboratory control record实验室控制记录laboratory information management
system(LIMS)
实验室信息管理系统local authorities当地药政部门
Loss on drying干燥失重
Meet the requirement符合要求
Melting point熔点
Melting range熔程microbiological specifications微生物标准microorganisms微生物
Milling磨粉
Mix-ups混放
modified facilities设施变更molecular formula分子式
Non-dedicated equipment非专用设备Operational qualification(OQ)运行确认
Out-of-specification不合格
Packaging包装
Particle size粒度
Perform a blank determination作一个空白对照Personnel Hygiene人员卫生
pilot scale中试规模
potable water饮用水
premises设施
process parameters工艺参数
Process validation工艺验证，过程验证product quality reviews产品质量回顾production batch records批生产记录proposed indication适应症
purification纯化
performance qualification(PQ)性能确认
Process flow diagrams(PFDS)工艺流程图product validation产品验证regulatory inspection evaluation药政检查
Related substance有关物质
release放行
Residual solvents残留溶剂
retention periods保留期限Retention samples留样
retention time保留时间Retrospective validation回顾性验证Revalidation再验证
review and approve审核并批准
route of administration给药途径Sanitation环境卫生
scale-up reports报产报告
serious GMP deficiencies严重GMP缺陷
Sip sterilization in place在线灭菌
sodium hydroxide氢氧化钠
Specific rotation比旋度specifications标准
stability date稳定性数据stability monitoring program稳定性监控计划status状态
sterile APIs无菌原料药sterilization消毒
succ essive batches连续批号
supplier供应商
technical transfer技术转化
total microbial counts微生物总数traceable可追踪的
turnover packages验证文件集
Validation master plan验证总计划
Validation report验证报告
常用中译英
系统system
物料平衡reconciliation
批batch or lot
批号batch number
批生产记录batch records
文件document
标准操作规程standard operating proceddures (SOP)生产工艺规程master formula
工艺用水water for processing
纯化水purified water
注射用水water for injection
状态标志status mark/label
中间产品intermediate product
理论产量theoretical yield
物料material
待验quarantine
起始原料staring material
洁净室(区)clean room(zone)
待包品bulk product
成品finished product
灭菌sterilization
控制点control point
质量监督quality surveillance
生产过程控制in-process control
退货returned product
拒收rejected
交叉污染cross contamination
放行released
质量要求quality requirement
可追溯性traceability
计量确认metrologial confirmation
人员净化室room for cleaning human body
物料净化室room for cleaning material
悬浮粒子airborne particles
洁净度cleanliness
净化cleaning
传递箱pass box
洁净服clean working garment
洁净工作台clean bench
静态at-rest
动态operational
粗效过滤器roughing filter
中效过滤器medium efficiency filter
高效过滤器hepa filter
安装确认instalation qualification(IQ)
运行确认operational qualification(OQ)
性能确认performance qualification(PQ)
工艺验证process validation