十五 制药常见词汇英文对照

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1、十五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particlesize原料药API磨粉milling指导原则guideline微粉micronizing符合要求MeettherequirementsGMP要求GMPrequirements纯度purity执行vimplement物料接收receiptofmaterials组织机构organisationalstructure生产production质量相关事物qualityrelatedact

2、ivities包装packaging偏差deviation重包装repackaging关键偏差Criticaldeviations贴标labelling评价evaluation重贴标relabelling药政检查regulatoryinspections质量控制qualitycontrol严重GMP缺陷seriousGMPdeficiencies放行release审核并批准reviewandapprove储存storage委派delegate销售distribution拒收reject安全方面safe

3、tyaspects包装物和标签packagingandlabellingmaterials环境保护protectionoftheenvironment实验室控制记录laboratorycontrolrecord国家法律nationallaws标准specifications注册registration主生产文件masterproductioninstructions人用药humandrug自检internalauditsself-inspections无菌原料药sterileAPIs合同生产商cont

4、ractmanufacturers消毒sterilization验证方案和报告validationprotocolsandreports当地药政部门localauthorities投诉complaints化学合成chemicalsynthesis维护maintaining提取extraction校正calibrating发酵fermentation稳定性数据stabilitydata排除exclude复验/失效日期retestorexpirydates临床试验clinicaltrials存储条件sto

5、rageconditions起始物料StartingMaterial产品质量回顾productqualityreviews结构单元structuralfragment批生产记录productionbatchrecords供应商supplier设施premises化学性质chemicalproperties设施变更modifiedfacilities具体分析case-by-case证实verify关键步骤criticalprocess纠偏措施correctiveactions前面几部earlyAPIst

6、eps工艺的稳定性consistencyoftheprocess最后几部finalsteps分析方法analyticalmethods纯化purification稳定性监控计划stabilitymonitoringprogram分离Isolation人员资格PersonnelQualifications需要书面写下shouldbespecifiedinwriting培训记录Recordsoftraining人员卫生PersonnelHygiene微生物总数totalmicrobialcounts顾问C

7、onsultants控制菌objectionableorganisms潜在污染potentialcontamination非无菌non-sterile微生物标准microbiologicalspecifications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airdriers书面程序Writtenprocedures反作用影响adverselyaffect设备维护EquipmentMaint

8、enance蒸汽steam预防性维护preventativemaintenance通风ventilation集中生产campaignproduction图纸Drawings清洗媒介cleaningagents空气过滤airfiltration卸disassembling排气exhaust连续批号successivebatches交叉污染cross-contamination非专用设备Non-dedicatedequipment空气压力airpressur