GMP数据完整性和计算机管理培训.pptxVIP

GMP数据完整性和计算机管理培训 内 容FDA 对数据完整性要求MHRA（英国药监机构）数据完整性指南要求计算机管理要求FDA 数据完整性要求Data IntegrityFDA检查发现What FDA Observed during Inspections数据完整性问题Data Integrity Issues（1）FDA检查发现事实 FDA Observed Facts:未及时记录 Not recording activities contemporaneously倒签日期 Backdating没有原始记录或记录造假 No raw data and/or fabricating data复制历史数据作为新数据 Copying existing data as new data重复进样和预检测 Re-running samples and pre-testing丢弃数据（无效数据未说明） Discarding data (invalid data without justification)数据完整性问题Data Integrity Issues (2)没有原始数据 No raw data for:标准品配制 Standard preparation样品称重 Sample weights样品溶液准备和样品稀释Sample solution preparation and sample dilutions没有这些信息，无法计算结果Without this information, assays cannot be calculated.数据完整性问题Data Integrity Issues (3)分析方法没有很好执行Analytical Methods are not well-defined and followed调整HPLC的积分参数 Change HPLC integration parameters 重新进样直到结果符合 Re-run samples until passing results obtained重新计算直到结果符合 Re-calculate until acceptable results obtained测试时间和记录报告不匹配Time used for complete the tests not added up with the time purported in the records审计追踪功能没有启用或没有审核Audit trail function was disabled or not reviewed数据完整性问题Data Integrity Issues (4)QC实验室数据 Quality Control Data某批次的结果数据应用于其他批次的放行Test results from one batch were used to release other batches电子版本与打印版本不一致Discrepancies between electronic and printed versions数据完整性问题Data Integrity Issues (4)QC实验室数据 Quality Control Data转抄数据（从小纸片上转抄到实验室记录本中）Transcribing data (from small pieces of paper onto analytical worksheets)首次记录的数据为原始数据The first recorded data is considered as the original raw data因此丢弃了原始数据Therefore, discarding the “original raw data”增加了转抄的风险Increase the risk of transcription errors转抄错误从不会发现并组织调查Transcription errors would never be detected in the event of investigation同样数据先用铅笔填写，随后抹去, 然后进入使用永久性墨水稍后提供虚假印象按时记录。数据完整性问题Data Integrity Issues (5)QC实验室数据 Quality Control Data在系统适应性运行前预检测, Pre-testing samples before system suitability runs非正式样品使用不同的名字，例如“测试/小试、演示、培训等”Unofficial testing of samples with different file names, such as, Test, Trail, Demo, a