制药常见词汇英文对比(7页)Good is good, but better carries it.精益求精，善益求善。制药常见词汇英文对比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...
