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制药⾏业常⽤英语词汇（缩写、中英⽂对照）

序号中⽂英⽂及缩写

1药品⽣产质量管理规范GMP：GoodManufacturingPractice

2国家⾷品与药品监督管理局StateFoodandDrugAdministration

3总则GeneralProvisions

4《中华⼈民共和国药品管理法》theDrugAdministrationLawofthePeople'sRepublicofChina

5制剂Preparation

6原料药API:ActivePharmaceuticalIngredient

7成品finishedgoods

8⼯序process

9机构与⼈员organizationandpersonnel

10专业知识professionalknowledge

11⽣产经验productionexperience

12组织能⼒organizationalskill

13技术⼈员technicalstaff

14实施implementation

15药品⽣产pharmaceuticalmanufacturing

16质量管理qualitymanagement

17质量检验qualityinspection

18专业技术培训professionalandtechnicaltraining

19基础理论知识basictheoreticalknowledge

20实际操作技能practicaloperationskills

21⾼⽣物活性highlypotent

21⾼⽣物活性highlypotent

22⾼毒性hightoxicity

23污染contamination

24考核评估asssment

25⼚房与设施buildingsandfacilities

26⽣产环境productionenvironment

27空⽓洁净级别cleanairlevel

28昆⾍inct

29洁净室（区）cleanroom(area)

30光滑smooth

31⽆裂缝nocracks

32⽆颗粒物脱落noparticleshedding

33耐受endure

34消毒disinfection

35⽆菌sterile

36交界处junction,joint

37弧形arc

38灰尘积聚duesaccumulation

39储存区storearea

40⽣产规模productionscale

41设备equipment

42物料material

43中间产品intermediateproduct

44待验品quarantinedmaterial

45交叉污染cross-contamination

46管道pipeline,ductwork

47风⼝tuber

48公⽤设施,公⽤⼯程utilitiesofpublicrvice

49照明lighting

50照度illumination

51应急紧急情况emergency

52净化purification,clean

53微⽣物,微⽣物学,微⽣物的micro-organism,microbiology,microbiologic

54监测monitoring

55记录record

56天棚天花板ceiling,roof

57密封al

58静压差StaticDifferentialPressure

59温度temperature

60相对湿度RH:RelativeHumidity

61低漏地漏floordrainer

62青霉素penicillin

63分装室paratingroom,fillingroom

64相对负压relativenegativepressure

65废⽓wastegas,exhaustedair

66β－内酰胺结构类药品β-Lactastructuredrug,drugsofβ-Lacticgroup

67避孕药品contraceptives

68激素类hormone

69抗肿瘤类anti-tumor,oncology

70放射性药品Radiopharmaceuticals

71包装packing,package

72循环使⽤recycling

73微粒particles

74辐射radiation,irradiation

75细菌bacteria

76病毒virus

77细胞cell

78脱毒前后preandpostdetoxification

79活疫苗与灭活疫苗activevaccine/inactivatedvaccine

80⼈⾎液制品bloodproducts

81预防制品preventionproducts

82灌装filling

83中药Chinetraditionalmedicines

84前处理pretreatment

85提取extraction

86浓缩concentration

87动物脏器visceraofanimal,organofanimal

88蒸、炒、炙、煅steaming,frying,sunburn,testing

89炮制concocted

90通风ventilation

91除烟smokeremoval

92除尘dustremoval

93降温设施temperature-reducingestablishment,cooling

94筛选screening,sift

95切⽚slicing

96粉碎grinding

97压缩空⽓compresdair

98惰性⽓体noblegas

99取样Sampling

100称量室weighingroom,dispensingroom

101中药标本Chineherbalsample,exemplarofTCM

102检定鉴定verification,identification

103同位素Isotope

104设备equipment

105选型model/typelection

106耐腐蚀anticorrosion

107吸附adsorption,absorption

108润滑剂,润滑lubricant,lubricate

109冷却剂coolant

110流向flowdirection

111纯化⽔PW:PurifiedWater

112注射⽤⽔WFI:WaterforInjection

113滋⽣breeding

114储罐tank

115死⾓neglectedportion

116盲管blindpipe

117纤维fiber

118疏⽔性hydrophobicity

119仪表instrumentation

120量具measuringtool

121衡器weighinginstrument

122精密度precision

123维修maintenance

124不合格disqualifiedreject

125物料material

126购买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

132挥发性volatile

133净药材netmedicine,netTCM

134⿇醉药品narcotics

135精神药品psychotropicdrug

136易燃combustible

137易爆explosive

138验收acceptance

139使⽤说明书instruction

140标签label

141卫⽣,清洁/消毒sanitation

142车间,辅房workshop

143间隔时间timeinterval

144清洁剂detergent

145消毒剂disinfectant

146废弃物wastes

147更⾐室changingroom

148⼯作服,workclothes

149颗粒性物质,颗粒剂granules

150耐药菌株drug-resistantstrain

151传染病infectiousdia

152⽪肤病dermatitis

153验证verification,validation

154确认qualification

154确认qualification

155安装installation

156运⾏runningoperation

157性能performance

158原辅料rawmaterialandincipient

159⽂件document

160投诉complaint

161报废reject

162品名productname

163处⽅preion,formula

164技术参数technicalparameter

165容器container

166半成品mi-finishedproduct,intermediate

167申请application

168稳定性stability

169起草draft

170⽣产管理productionmanagement,manufacturingcontrol.

171事故accident

172混淆mix-up

173喷雾spray

174合格证certificate

175清场clearance

176质量管理qualitymanagement

177内控internalcontrol,on-linetest

178滴定液tartan

179培养基medium

180有效期validity,expirydate,shelflife

181产品销售与收回productsalesandrecovery/recall

182投诉与不良反应报告complaintsandadverreaction

183⾃检lf-inspection

184附则scheduleappendix

185平衡balance

186饮⽤⽔drinkingwater,potablewater

187蒸馏法distillation

188离⼦交换法ionexchange

189反渗透法RO:ReverOsmosis

190附加剂添加剂additives

191滞留strandedresort

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ActiveIngredient

196⾮活性成份Inactiveingredient

197中间产品in-processproduct,intermediateproduct

198批号batchnumber

199药⽤物料medicatedfeed

200药⽤预混合料medicatedpremix

201质量控制部门Qualitycontroldepartment

202理论产量Theoreticalyield

203实际产量Actualyield

204⽐率Percentage,rate

205验收标准可接受标准Acceptancecriteria

206代表性样品Reprentativesample

207微粒状的particulate

208污染物contaminant

209⽯棉asbestos

210诊断diagnosis

211缓解mitigation

212化学变化chemicalchange

213组分ingredient,component

214制备fabricatepreparation

215复合compound

216混合blend

217加⼯processing

218浓度concentration

219单位剂量unitdo

220药品包装容器drugproductcontainers

221密封件,封盖closure

222效价Titer

223纯度purity

224规格strength

225监督supervi,monitor

226实验室laboratory

227⽆菌操作apticoperation,sterileoperation

228层流laminarflow

229湍流turbulentairflow

230空⽓过滤airfiltration

231空⽓加热airheating

232预过滤器profiler

233排⽓系统exhaustsystem

234管件plumbing

235虹吸倒流back-siphonage

236污⽔wage

237废料refu

238盥洗设备toiletfacilities

239空⽓⼲燥器airdrier

240垃圾trash

241有机废料organicwaste

242杀⿏剂rodenticides

243杀昆⾍剂incticides

243杀昆⾍剂incticides

244杀真菌剂fungicides

245熏蒸剂fumigatingreagents

246去垢剂cleaningagents

247消毒剂sanitizingagents

248滂沱剂lubricant

249⾃动化设备automatic,mechanical,orelectronicequipment

250微型胶卷microfilm

251注射剂injection

252灭菌设备sterilizationequipment

253⽆菌取样技术apticsamplingtechniques

254显微镜microscope

255热源,内毒素pyrogen,endotoxin

256偏差deviation

257变更changecontrol

258进料charge-in

259项⽬代码itemcode

260鉴别identify

261⽚剂tablet

262胶囊capsule

263颗粒剂granule

264溶解时间溶出时间dissolutiontime

265澄明度clarity

265澄明度clarity

266隔离系统quarantinesystem,isolationsystem

267返⼯reprocessing

268发放issuance,relea

269⾮处⽅药OTC:over-the-counter

270处⽅药preedmedicine

271⽪肤科药、⽛粉、胰岛素、喉⽚dermatological,dentifrice,insulin,orthroatlozengeproduct

272保险包装tamper-resistantpackage

273明胶硬胶囊hardgelatincapsule

274顺势治疗homeopathic

275⼊库warehousing

276变质deteriorate

277准确性accuracy

278灵敏性nsitivity

279特异性specificity

280重复性reproducibility,repeatability

281变应原提取物allergenicextracts

282眼膏ophthalmicointment

283粗糙或磨蚀物质harshorabrasivesubstances

284控释制剂controlled-releadosageform

285实验动物laboratoryanimals

286供应商Supplier

287光谱spectrum

288测量单位unitsofmeasure

289换算系数conversionfactors

290试剂reagent

291安慰剂placebo

292明确地explicitly

293取代superde

294溶液solution

295批准approval

296(美国)⾷品药品监督管理局FDA:FoodandDrugAdministration

297标准操作程序SOP:StandardOperatingProcedure

298质量保证QA:QualityAssurance

299质量控制QC:QualityControl

300批⽣产记录BPR:BatchProductionRecord

301批检验记录BAR:BatchAnalysisRecord

302⼯艺规程PP:ProcessProcedure

303健康,安全,环保EHS:Environment,HealthandSafe

304美国联邦法规CFR:CodeofFederalRegulation

305美国药典USP:TheUnitedStatesPharmacopeia

306欧洲药典EP:Europeanpharmacopeia

307英国药典BP:Britishpharmacopeia

308药物主⽂件DMF:DrugMasterFile

309验证主计划VMP:ValidationMasterPlan

310验证⽅案VP:ValidationProtocol

311验证报告VR:ValidationReport

312安装确认IQ:InstallationQualification

313运⾏确认OQ:OperationQualification

314性能确认PQ:PerformanceQualification

315超出标准(限度)OOS:OutofSpecification

316冻⼲产品freeze-dryproduct,lyophilizatedproduct

317⼯⼚主述⽂件SMF:SiteMasterFile

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