在2019.04.15日12:50，分析员陆启明检测3040-A190

At 2019.04. At 12:50 on the 15th, an analyst Lu Qiming detect 3040-A190405-CLC approved rosuvastatin calcium statin side chain alcohol when he found that the solvent peak is small, carefully review the batch table and sample tray, find sample tray 203 is not placed on the sample position, sample No. 204 is placed. <br><br>The fundamental reason for the deviation occurs 1) the end of the experimental operation, the experimenter is not cleared up the operating table, cross-contamination. 2) When the actual sequence table Analyst set position error samples provided 203, resulting in inconsistency bottle batch number and the actual table position sample vial, and the reviewer also Wang Liying not checked out this problem, resulting in 3040-A190405-CLC batch rosuvastatin calcium into the wrong kind of a side chain alcohol solution, the abnormality detecting pattern appears as a man-made causes. <br><br>The deviation of the laboratory bias, are the reasons staff, 3040-A190405-CLC approved rosuvastatin calcium side chain alcohol detection spectrum set aside reserves to dope test report issued retest results. <br><br>1. The original map set aside reserves to re-dope tests to retest the results of test report issued. <br>2. Training H0-SOP-72022 laboratory management procedures of the relevant personnel, stressed that the end of the experimental operation, the experimenter should be cleared up operating table, to avoid cross-contamination. <br>3. relevant personnel "H3-SOP-61081 IPC laboratory test sample management procedures" and "H0-SOP-72047 laboratory management audit review program" Retraining, emphasizing analysts who review and review, in accordance with the list carefully review review, and live demonstrations. <br>4. analyst Lu Qiming Wang Liying people to experiment and review procedures three months of tracking.

在2019.04.15日12:50，分析员陆启明检测3040-A190405-CLC批瑞舒伐他汀钙侧链醇时，发现溶剂峰偏小，仔细查看批处理表与进样盘，发现进样盘203号位上未放置样品，样品放置在204号位上。 <br><br>本次偏差发生的根本原因为1）实验操作结束后，实验员未及时清理操作台面，造成交叉污染。2)分析员设置序列表时将实际样品位置错误设置成203号，导致批处理表的瓶号与实际进样小瓶位置不一致，而复核者王丽颖也未核对出此问题，导致3040-A190405-CLC批瑞舒伐他汀钙侧链醇溶液进错样，检测图谱出现异常，为人为原因。 <br><br>该偏差为实验室偏差，属于人员原因， 3040-A190405-CLC批瑞舒伐他汀钙侧链醇检测图谱作废保留，以原液复测结果出具检测报告。 <br><br>1.原图谱作废保留，原液重新检测，以复测结果出具检测报告。<br>2.对相关人员进行H0-SOP-72022实验室管理程序的培训，强调实验操作结束后，实验员应及时清理操作台面，避免造成交叉污染。<br>3.对相关人员进行“H3-SOP-61081 IPC实验室样品检验管理程序”和“H0-SOP-72047实验室复核审核管理程序”再培训，强调分析者和复核者复核时，按照复核清单仔细复核，并进行现场演示。<br>4.对分析员陆启明和复核人王丽颖进行3个月的实验程序跟踪。

At 12:50 on April 15, 2019, when analyst Lu Qiming detected 3040-a190405-clc batch of rosuvastatin calcium side chain alcohol, it was found that the solvent peak was small. Carefully check the batch table and the sample tray, and it was found that no sample was placed on position 203 of the sample tray, and the sample was placed on position 204.<br>The root cause of this deviation is 1) after the experiment, the experimenter did not clean the operation table in time, resulting in cross contamination. 2) When the analyst set up the sequence table, the actual sample position was set to No. 203, which led to the inconsistency between the bottle number of the batch table and the actual injection vial position, and the reviewer Wang Liying did not check out the problem, which led to the wrong injection of 3040-a190405-clc batch of rosuvastatin calcium side chain alcohol solution, and the abnormal detection pattern was caused by human factors.<br>The deviation is laboratory deviation, which belongs to personnel reasons. The 3040-a190405-clc batch of rosuvastatin calcium side chain alcohol detection map is invalid and reserved, and the test report is issued based on the retest results of the original solution.<br>1. The original atlas is invalid and reserved, the original solution is retested, and the test report is issued based on the retest results.<br>2. Train relevant personnel on the management procedure of h0-sop-72022 laboratory, and emphasize that after the completion of the experiment, the experimenter should clean up the operation table in time to avoid cross contamination.<br>3. Retraining the relevant personnel in "h3-sop-61081 IPC laboratory sample inspection management procedure" and "h0-sop-72047 laboratory review and audit management procedure", emphasizing that when the analyst and reviewer review, carefully review according to the review list, and conduct on-site demonstration.<br>4. Follow up the experimental procedure of analyst Lu Qiming and reviewer Wang Liying for 3 months.