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
成品
finished goods
工序
process
机构与人员
organization andpersonnel
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
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
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
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
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
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
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
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
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;
Process instruction
Livzon Group Fuzhou Fuxing Pharmaceutical Co. Ltd.
Hunan Erkang Pharmaceutical Co., Ltd
Hunan Huari Pharmaceutical Co., Ltd
Guangzhou Chemical Reagent Factory
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 andfacilities
生产环境
production environment
空气洁净级别贴签和Fra bibliotek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