1.药品生产质量治理标-准
GMPGood ManufacturingPractice
2.国家食物与药品监视治理局
State Food andDrug Administration
3.总则
GeneralProvisions
4.《中华农民共和国药品治理法》
the DrugAdministration Law of the People's Republic of China
5.制剂
Preparation
6.本料药
API: Active PharmaceuticalIngredient
7.制品
finished goods
8.工序
process
9.机构与职员
organization and personnel
10.专注学
professional knowledge
11.生产经验
production experience
12.组织才气
organizational skill
13.技术职员
technical staff
14.实行
implementation
15.药品生产
pharmaceutical manufacturing
16.质量治理
quality management
17.质量检查
quality inspection
18.专注技术培训
professional and technicaltraining
19.基本理-论学
basic theoreticalknowledge
20.现实操做技术
practical operationskills
21.高动物活性
highly potent
22.高性
high toxicity
23.污浊
contamination
24.审核评价
assessment
25.厂房与装备
buildings and facilities
26.生产环-境
production environment
27.空-气清洁级别
clean air level
28.虫子
insect
29.清洁室（区）
clean room(area)
30.平滑
smooth
31.无裂痕
no cracks
32.无颗粒物脱落
no particle shedding
33.耐受
endure
34.消
disinfection
35.无菌
sterile
36.接壤处
junction, joint
37.弧形
arc
38.灰尘积累
dues accumulation
39.贮存区
store area
40.生产范围
production scale
41.装备
equipment
42.物料
material
43.中心成品
intermediate product
44.待验品
quarantined material
45.交织污浊
cross-contamination
46.管道
pipeline, ductwork
47.风口
tuber
48.公用装备, 公用工程
utilities of publicservice
49.照明
lighting
50.照度
illumination
51.应急 紧急情形
emergency
52.清洁
purification, clean
53.微动物, 微动物学, 微动物的
micro-organism, microbiology,microbiologic
54.监测
monitoring
55.纪录
record
56.天棚 天花板
ceiling, roof
57.密封
seal
58.静压差
Static DifferentialPressure
59.温度
temperature
60.对应湿度
RH: Relative Humidity
61.低漏 地漏
floor drainer
62.青霉素
penicillin
63.分装室
separating room, fillingroom
64.对应负压
relative negativepressure
65.废气
waste gas,exhausted air
66.β－内酰胺结构类药品
β-Lactasestructure drug, drugs of β-Lactic group
67.避孕药品
contraceptives
68.激素类
hormone
69.抗肉类
anti-tumor, oncology
70.喷射性药品
Radiopharmaceuticals
71.包装
packing, package
72.重复运用
recycling
73.微粒
particles
74.辐射
radiation, irradiation
75.细菌
bacteria
76.病
virus
77.细胞
cell
78.脱先后
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 products
82.灌装
filling
83.中药
Chinesetraditional medicines
84.前处置
pretreatment
85.提取
extraction
86.压缩
concentration
87.动物脏器
viscera of animal,organ of animal
88.蒸.炒.炙.煅
steaming, frying,sunburn, testing
89.炮制
concocted
90.透风
ventilation
91.除烟
smoke removal
92.除尘
dust removal
93.降温装备
temperature-reducingestablishment, cooling
94.挑选
screening, sift
95.切片
slicing
96.破碎
grinding
97.松缩空-气
compressed air
98.惰性气体
noble gas
99.取样
Sampling
100.称量室
weighing room, dispensingroom
101.中药标本
Chinese herbal sample,exemplar of TCM
102.检定 判定
verification, identification
103.同位素
Isotope
104.装备
equipment
105.选型
model/type selection
106.耐侵蚀
anticorrosion
107.吸附
adsorption, absorption
108.平滑剂, 平滑
lubricant, lubricate
109.冷却剂
coolant
110.流向
flow direction
111.纯化水
PW: Purified Water
112.注射用水
WFI: Water for Injection
113.滋生
breeding
114.储罐
tank
115.死角
neglected portion
116.盲管
blind pipe
117.纤维
fiber
118.疏水性
hydrophobicity
119.仪表
instrumentation
120.量具
measuring tool
121.衡器
weighing instrument
122.精致度
precision
123.修理.调养
maintenance
124.分歧格
disqualified reject
125.物料
material
126.购置
purchasing
127.发放
releasing
128.产地
origin
129.入库
loading
130.固体
solid
131.液体
liquid
132.挥发性
volatile
133.净药材
net medicine, netTCM
134.***品
narcotics
135.精神药品
psychotropic drug
136.易燃
combustible
137.易爆
explosive
138.验收
acceptance
139.运用运用办法
instruction
140.标签
label
141.卫生, 清洁/消
sanitation
142.车间, 辅房
workshop
143.距离时刻
time interval
144.清洁剂
detergent
145.消剂
disinfectant
146.荒凉物
wastes
147.换衣室
changing room
148.工做服,
work clothes
149.颗粒性物质, 颗粒剂
granules
150.耐药菌株
drug-resistant strain
151.传患病
infectiousdisease
152.肌肤病
dermatitis
153.检查
verification, validation
154.确认
qualification
155.安置
installation
156.运转
running operation
157.功效
performance
158.本辅料
raw material and incipient
159.文件
document
160.告密
complaint
161.报废
reject
162.品名
product name
163.处方
preion, formula
164.技术参数
technicalparameter
165.容器
container
166.半制品
semi-finished product,intermediate
167.申请
application
168.稳固性
stability
169.起草
draft
170.生产治理
production management,manufacturing control.
171.事件
accident
172.混淆
mix-up
173.喷雾
spray
174.及格证
certificate
175.清场
clearance
176.质量治理
quality management
177.内控
internal control,on-line test
178.滴定液
tartan
179.培育基
medium
180.有用期
validity, expiry date,shelf life
181.成品售卖与收回
product sales andrecovery /recall
182.告密与不良反映报-告
complaints and adversereaction
183.自检
self-inspection
184.附 则
schedule appendix
185.平衡
balance
186.饮用水
drinking water, potablewater
187.蒸馏法
distillation
188.离子调换法
ion exchange
189.反渗透法
RO: Reverse Osmosis
190.附加剂增添剂
additives
191.滞留
stranded resort
192.批
batch, lot
193.组分, 组成
component
194.无纤维脱落的过滤器
non-fiber-releasingfilter
195.活性成份
Active Ingredient
196.非活性成份
Inactive ingredient
197.中心成品
in-process product,intermediate product
198.批号
batch number
199.药用物料
medicated feed
200.药用预混淆料
medicated premix
201.质量掌控部门
Quality control department
202.理-论产量
Theoretical yield
203.现实产量
Actual yield
204.比率
Percentage, rate
205.验收标-准可吸收标-准
Acceptance criteria
206.代表性样板
Representative sample
207.微粒状的
particulate
208.污浊物
contaminant
209.石棉
asbestos
210.诊断
diagnosis
211.缓解
mitigation
212.化学转变
chemical change
213.组分
ingredient, component
214.制备
fabricate preparation
215.复合
compound
216.混淆
blend
217.加工
processing
218.浓度
concentration
219.单元剂量
unit dose
220.药品包装容器
drug product containers
221.密封件, 封盖
closure
222.效价
Titer
223.纯度
purity
224.规格
strength
225.监视
supervise, monitor
226.试验室
laboratory
227.无菌操做
aseptic operation,sterile operation
228.层流
laminar flow
229.湍流
turbulent air flow
230.空-气过滤
air filtration
231.空-气加热
air heating
232.预过滤器
profiler
233.排气体制
exhaust system
234.管件
plumbing
235.虹吸倒流
back-siphon age
236.污水
sewage
237.废物
refuse
238.盥洗装备
toilet facilities
239.空-气缓慢器
air drier
240.废物
trash
241.有机废物
organic waste
242.杀鼠剂
rodenticides
243.杀虫子剂
insecticides
244.杀真菌剂
fungicides
245.熏蒸剂
fumigating reagents
246.去垢剂
cleaning agents
247.消剂
sanitizing agents
248.澎湃剂
lubricant
249.努力化妆备.机械化妆备和电子装备
automatic, mechanical,or electronic quipment
250.微型胶卷
microfilm
251.注射剂
injection
252.灭菌装备
sterilization equipment
253.无菌取样技术
aseptic sampling techniques
254.显微镜
microscope
255.热源, 内素
pyrogen, endotoxin
256.误差
deviation
257.变换
change control
258.进料
charge-in
259.事情事件代码
item code
260.判别
identify
261.片剂
tablet
262.胶囊
capsule
263.颗粒剂
granule
264.熔解时刻 溶出时刻
dissolution time
265.澄明度
clarity
266.隔绝体制
quarantinesystem, isolation system
267.返工
reprocessing
268.发放
issuance, release
269.非处方药
OTC:over-the-counter
270.处方药
preed medicine
271.肌肤科药.牙粉.胰岛素.喉片
dermatological, dentifrice,insulin, or throat lozenge product
272.保险包装
tamper-resistant package
273.明胶硬胶囊
hard gelatin capsule
274.顺势医疗抢救
homeopathic
275.入库
warehousing
276.变质
deteriorate
277.准确性
accuracy
278.敏捷性
sensitivity
279.特区别样的性别别的人
specificity
280.重复性
reproducibility, repeatability
281.变应本提取物
allergenic extracts
282.眼膏
ophthalmic ointment
283.粗拙或者磨蚀物质
harsh or abrasivesubstances
284.控释制剂
controlled-releasedosage form
285.试验动物
laboratory animals
286.供应商
Supplier
287.光谱
spectrum
288.丈量单元
units of measure
289.换算系数
conversion factors
290.试剂
reagent
291.抚慰剂
placebo
292.明确地
explicitly
293.取代
supersede
294.溶液
solution
295.允许
approval
296.(美国)食物药品监视治理局
FDA: Food and DrugAdministration
297.标-准操做程-序
SOP: Standard OperatingProcedure
298.质量保证
QA: Quality Assurance
299.质量掌控
QC:Quality Control
300.批生产纪录
BPR: Batch ProductionRecord
301.批检查纪录
BAR: Batch AnalysisRecord
302.工艺规程
PP: Process Procedure
303.安康,平安,环保
EHS: Environment,Health and Safe
304.美国联邦法例
CFR: Code of FederalRegulation
305.美国药典
USP: The United StatesPharmacopeia
306.欧洲药典
EP: European pharmacopeia
307.英国药典
BP: British pharmacopeia
308.药物主文件
DMF: Drug Master File
309.检查胁从划
VMP: Validation MasterPlan
310.检查计划
VP: Validation Protocol
311.检查报-告
VR: Validation Report
312.安置确认
IQ: Installation Qualification
313.运转确认
OQ: Operation Qualification
314.功效确认
PQ: Performance Qualification
315.逾越标-准()
OOS: Out of Specification
316.冻干成品
freeze-dry product,lyophilizated product
317.工厂主述文件
SMF: Site Master File
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