Free Essay

Method Management

In: Business and Management

Submitted By cyycyy51
Words 608
Pages 3
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GMP |Q7A |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 requirements |GMP要求 |GMP requirements |
|纯度 |purity |执行v |implement |
|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 |repackaging |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 environment |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 |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 |chemical 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 specified 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 procedures |
|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 |Acceptance 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 |electronic 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 solvents |
|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 determination |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 operation | | |

GMP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…...

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