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1、2015/9/7 1 Data Integrity in Pharmaceutical Manufacturing 药品生产行业的数据完整性 Prevention and Detection 预防及探查 Which one is more effective? Prevention Training Speak-up Culture Validation Detection Internal Auditing Third Party Auditing 哪一项措施更为有效？ 预防 培训 畅所欲言的文化 验证 探查 内部审计 第三方审计 2015/9/7 2 Deletion of data Ov
2、erwriting of data Testing into compliance Altering integration parameters Performing sample trial injections Administration privileges Backdoor Manipulation 数据删除 数据覆盖 重复检验直至获得满意的结果 修改积分参数 进行样本注射液预测试 管理权限 背后操纵 Chromatography 色谱分析 Different ways to delete data Folders Individual data files High risk o
3、f occurrence if the software is not monitored properly High risk of occurrence if non-compliant software is used High risk of occurrence if Analysts are not trained 使用不同的方法删除数据 文件夹 个人数据文件 如果对软件未能进行正确监控，发生该问题的风险很高 如果使用了不兼容的软件，发生该问题的风险很高 如果分析员没有接受培训，发生该问题的风险很高 Deletion of Data 数据删除 2015/9/7 3 Steve 1/
4、29/2013 13:05 Sequence - Acquire and Analyze Run 1 - D:DATA2013Finish ProductIbuprofen29012013001.dat Steve 1/29/2013 14:07 Sequence - Acquire and Analyze Run 2 - D:DATA2013Finish ProductIbuprofen29012013002.dat Steve 1/29/2013 15:03 Sequence - Acquire and Analyze Run 3 - D:DATA2013Finish ProductIbu
5、profen29012013003.dat Steve 1/29/2013 15:56 Sequence - Acquire and Analyze Run 4 - D:DATA2013Finish ProductIbuprofen29012013004.dat Steve 1/29/2013 17:01 Sequence - Acquire and Analyze Run 1 - D:DATA2013Finish ProductIbuprofen29012013001.dat Steve 1/29/2013 17:52 Sequence - Acquire and Analyze Run 2
6、 - D:DATA2013Finish ProductIbuprofen29012013002.dat Steve 1/29/2013 18:45 Sequence - Acquire and Analyze Run 3 - D:DATA2013Finish ProductIbuprofen29012013003.dat Steve 1/29/2013 19:35 Sequence - Acquire and Analyze Run 4 - D:DATA2013Finish ProductIbuprofen29012013004.dat Overwriting 数据覆盖 Sample Name
7、 Vial Injection Date Aquired Sample Set Name Blank 1 1 5/5/2013 3:51 Xyl_Stb_Assay_05052013 Sys Suit 2 1 5/5/2013 4:01 Xyl_Stb_Assay_05052013 Sys Suit 2 2 5/5/2013 4:11 Xyl_Stb_Assay_05052013 Sys Suit 2 3 5/5/2013 4:21 Xyl_Stb_Assay_05052013 Sys Suit 2 4 5/5/2013 4:31 Xyl_Stb_Assay_05052013 Sys Suit
8、 2 5 5/5/2013 4:41 Xyl_Stb_Assay_05052013 06L1001 Sample_1 3 1 5/5/2013 4:51 Xyl_Stb_Assay_05052013 06L1001 Sample_2 3 2 5/5/2013 5:01 Xyl_Stb_Assay_05052013 06L1002 Sample_1 4 1 5/5/2013 5:11 Xyl_Stb_Assay_05052013 06L1002 Sample_2 4 2 5/5/2013 5:21 Xyl_Stb_Assay_05052013 06L1003 Sample_1 5 1 5/5/2
9、013 5:31 Xyl_Stb_Assay_05052013 06L1003 Sample_2 5 2 5/5/2013 5:41 Xyl_Stb_Assay_05052013 Bkt Std 2 1 5/5/2013 5:51 Xyl_Stb_Assay_05052013 06L1002 Sample_1 4 1 5/5/2013 6:01 Xyl_Stb_Assay_05052013 06L1002 Sample_2 4 2 5/5/2013 6:11 Xyl_Stb_Assay_05052013 Testing Into Compliance 重复检验直至获得满意的结果 2015/9/
10、7 4 Altering Integration Parameters 修改积分参数 Trial sample analysis Prior to running the official/reported sample set, samples are pre-tested to determine if they will meet specifications Results are not documented and investigated according to written procedures Results often differ from the subsequen
11、t official analysis (e.g. fail specifications) Suggests that the analyst is choosing only those sample solutions found to be meeting specifications 预测试样本分析 在进行正式/报告样本集测试之前，预先进行测试以检验样本是否达标 对测试结果未能按照书面流程的要求进行记录和检查 测试结果经常与之后的正式测试结果不同（如：未达标） 说明分析员只选择达标的样本溶液上报 Trial Samples 预测试样本 2015/9/7 5 Name 样本名称样本名称
12、 Vial Position 进样口进样口 Sample Type 样本类型样本类型 Date Aquired 试验日期试验日期/时间时间 Trial Disso B0654-1 预测试溶解样本B0654-1 101 Unknown 未知 5/5/2013 18:45 Trial Disso B0654-2 预测试溶解样本B0654-2 102 Unknown 未知 5/5/2013 18:56 Trial Disso B0654-3 预测试溶解样本B0654-3 103 Unknown 未知 5/5/2013 19:05 Trial Disso B0654-4 预测试溶解样本B0654-4
13、104 Unknown 未知 5/5/2013 19:15 Trial Disso B0654-5 预测试溶解样本B0654-5 105 Unknown 未知 5/5/2013 19:27 Trial Disso B0654-6 预测试溶解样本B0654-6 106 Unknown 未知 5/5/2013 19:43 Sample Trial Injections Case Study 预测试样本注射液案例研究 Trial Injections 预测试注射液 Official Standard Injection 正式标准注射液 Official Sample Injection 4 hour
14、 Acid 正式样本注射液-4小时酸溶 Sample Trial Injections Case Study 预测试样本注射液案例研究 2015/9/7 6 4 hour acid dissolution specification = NLT 60% 4小时酸溶标准=不小于60% Name 样本名称 Vial Position 进样口 Peak Area 峰面积 % Dissolution 溶解度% Meets Specification 是否达标 Trial Disso B0654-1 预测试溶解样本B0654-1 101 111,312 65% Yes 是 Trial Disso B06
15、54-2 预测试溶解样本B0654-2 102 120,561 70% Yes 是 Trial Disso B0654-3 预测试溶解样本B0654-3 103 115,984 68% Yes 是 Trial Disso B0654-4 预测试溶解样本B0654-4 104 60,837 30% No 否 Trial Disso B0654-5 预测试溶解样本B0654-5 105 110,512 64% Yes 是 Trial Disso B0654-6 预测试溶解样本B0654-6 106 65,943 33% No 否 Name 样本名称 Vial Position 进样口 Peak Area 峰面积 % Dissolution 溶解度% Meets Specification 是否达标 B0654 Acid 4 hours 1 4小时酸溶B0654-1 101 111,453 65% Yes 是 B0654 Acid 4 hours 2 4小时酸溶B0654-2 102 120,123 70% Yes 是 B0654 Acid 4 hours 3 4小时酸溶B0654-3 103 115,894 68% Yes 是 B0654 Acid 4 hours 4 4小时酸溶B0654-4 104 11
