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1、制药常见词汇英文对照中文英文中文英文国际协调会议ICH颗粒granulation原料药GMPQ7A粒度particle size原料药API磨粉milling指导原则guideline微粉micronizing符合要求Meet the requirementsGMP要求GMP requirements纯度purity执行vimplement物料接收receipt of materials组织机构organisational structure生产production质量相关事物quality related activities包装packaging偏差deviation重包装repackag
2、ing关键偏差Critical deviations贴标labelling评价evaluation重贴标relabelling药政检查regulatory inspections质量控制quality control严重GMP缺陷serious GMP deficiencies放行release审核并批准review and approve储存storage委派delegate销售distribution拒收reject安全方面safety aspects包装物和标签packaging and labelling materials环境保护protection of the environme
3、nt实验室控制记录laboratory control record国家法律national laws标准specifications注册registration主生产文件master production instructions人用药human drug自检internal audits self-inspections无菌原料药sterile APIs合同生产商contract manufacturers消毒sterilization验证方案和报告validation protocols and reports当地药政部门local authorities投诉complaints化学合成
4、chemical synthesis维护maintaining提取extraction校正calibrating发酵fermentation稳定性数据stability data排除exclude复验/失效日期retest or expiry dates临床试验clinical trials存储条件storage conditions起始物料Starting Material产品质量回顾product quality reviews结构单元structural fragment批生产记录production batch records供应商supplier设施premises化学性质chemi
5、cal properties设施变更modified facilities具体分析case-by-case证实verify关键步骤critical process纠偏措施corrective actions前面几部early API steps工艺的稳定性consistency of the process最后几部final steps分析方法analytical methods纯化purification稳定性监控计划stability monitoring program分离Isolation人员资格Personnel Qualifications需要书面写下should be speci
6、fied in writing培训记录Records of training人员卫生Personnel Hygiene微生物总数total microbial counts顾问Consultants控制菌objectionable organisms潜在污染potential contamination非无菌non-sterile微生物标准microbiological specifications专用的Dedicated混淆mix-ups无水Sewage待验quarantine垃圾Refuse洗涤剂detergent卫生Sanitation手烘器air driers书面程序Written p
7、rocedures反作用影响adversely affect设备维护Equipment Maintenance蒸汽steam预防性维护preventative maintenance通风 ventilation集中生产campaign production图纸Drawings清洗媒介cleaning agents空气过滤air filtration卸disassembling排气exhaust连续批号successive batches交叉污染cross-contamination非专用设备Non-dedicated equipment空气压力air pressure可接受标准Acceptan
8、ce criteria尘埃dust残留residues微生物microorganisms清洁程序cleaning procedures回风recirculate状态status管道pipework预先计划established schedule中间体intermediate可追踪的traceable排水沟Drains对 有影响had an impact on饮用水potable water计算机化系统Computerized Systems文件系统Documentation System电子格式electronic form修订历史revision histories电子签名electroni
9、c signatures扩产报告scale-up reports中间控制in-process controls技术转化technical transfer内控检测in-house testing开发历程报告development history reports中试规模pilot scale保留期限retention periods历史数据historical data生产工艺规程Master Production Instructions不合格Out-of-specification工艺参数process parameters混批Blending Batches批量batch size一级对照
10、品primary standard时间限制time limits杂质概况impurity profile预期产量expected yield微生物检测microbiological tests实际产量Actual yield商业规模commercial scale关键物料critical materials留样Retention Samples进厂物料incoming materials预验证Prospective validation回顾性验证retrospective validation结晶crystallization不少于not less than回收溶剂recovered solv
11、ents不大于not more than母液mother liquors摄氏度centigrade重新加工Reworking兽用Veterinary use保留时间retention time氢氧化钠sodium hydroxide拆分溶液Resolution solution盐酸hydrochloric acid水分water甲醇methanol重金属Heavy metal残留溶剂Residual solvents 流动相Mobile phase炽灼残渣Residue on ignition柱子column含量Assay容器Container作一个空白对照Perform a blank de
12、termination剂型dosage form鉴别Identification 规格strength熔点Melting point适应症proposed indication熔程Melting range 给药途径route of administration干燥失重Loss on drying辅料Excipient有关物质Related substance 结构式structural formula比旋度Specific rotation分子式molecular formula无水anhydrous静态at rest动态in operationGMP车间房间名称中英文对照 更衣室 Changing Room一更 First Changing Room手消室 Hands Disinfection Room气闸室 Airlock Room洁具室 Cleaning Tools Room清洗室 Cleaning Room模具室 Dies Room内包装室 Immediate Package Room安全门 Emergency Door外包清室Outer Package Removing Room存料间Storage Room of Raw Materials粉碎室 Pulverizing Room
