制药行业GMP英文词汇

1、精品文档Approve批准Artwork药品标签Authorized Person ， AQ WHO关于质量受权人Bacteriostatic Water for Injection抑菌注射用水Batch-based production按批次生产Blending 混合Blending batches混批Calibration校验Calibration校准Campaign-based production阶段性生产Checked 校验Cleanance or site cleaning清场Cleaning 清洁Cleaning Validation清洁验证Clinical Trials临床研究

2、Contamination 污染Contamination Control污染控制Continuous production连续生产Contract manufacturing委托生产Contract Analysis委托检验Cool Storage 阴凉储存Critical Deviation关键偏差Critical Process Parameter关键工艺参数Critical Processing Step关键操作步骤Cross contamination 交叉污染Design qualification, DQ设计确认Deviation偏差Drinking Water 饮用水Dry P

3、lace干燥储存education个人学历Equipment logbook设备使用日志Excessive heat 过热Expected Yield, expected预期收率experience工作经验Expiry Date有效期Factory Acceptance Test， FAT 供应商工厂的验收测试Freezer Storage冷冻储存Holding Time贮存期I ：Implemente 执行Impurity profile杂质概况In-process Controls过程控制In-process Sampling过程取样Installation qualification,

4、IQ安装确认。1 欢迎下载精品文档Intermediate中间体Logbook 使用日志Maintenance Basic Practice维护基本实践Maintenance Best Practice维护最佳实践Maintenance Good Practice维护良好实践Maintenance Plan维护计划Maintenance Program维护管理程序Manufacture制造Master Cell Bank , MCB主细胞库mix-ups 混淆Non-conformance不合格Operation qualification, OQ运行确认Out of Specificatio

5、n , OOS超标Performance qualification, PQ性能确认Preliminary Cell Bank ,PCB原始细胞库Preventive Maintenance预防性维护Production 生产Production Operations生产操作Purified Water纯化水Qaultiy Assurance， QA 质量保证Qualification确认Qualified Person，QP 质量受权人Quality Agreement质量协议Quality Control ，QC 质量控制Quality Management ，QM质量管理Quality

6、review质量审核Quality Unit， QU/Quality Operations ，QO质量管理部门Responsible负责Rechecked 复验Reconciliation物料平衡Refrigerator Storage冷藏储存Reject 拒收Retest dates复验期Risk Assessment风险评估Room Temperature Storage室温储存Safety Environment Health, EHS环境、健康及安全Semi-continuous production半连续生产Site Acceptance Test， SAT 用户工厂的验收测试Spe

7、cification质量标准Stability稳定性Sterile Purified Water灭菌纯化水Sterile Water for Inhalation灭菌吸入用水。2 欢迎下载精品文档Sterile Water for Injection灭菌注射用水Sterile Water for Irrigation灭菌冲洗用水Subdividing Operation分装操作Tamper Evidence防篡改封签Time Limits生产时限training 培训Update Batch Production Record, BPR批记录User Requirement Specification, URS用户需求标准Validation验证Validation master plan验证主计划Verification复核Verification检定Water for Injection注射用水Working Cell Bank , WCB工作细胞库Worst Case最差情况Yield 收率Yield , actual实际收率Sign