2019.07.29日16:38，209车间王望娥在Y53幢二楼在对辛

On July 29th, 2019 at 16:38, Wang Wange of Workshop 209, on the second floor of Building Y53, was performing a TLC test on the cyclization reaction solution 3011-B2190751-HH of simvastatin 3011-B2190751-CP, and found that the sample climbing plate was abnormal After the simvastatin 3011-B2190751-CP batch climbing board developed color, the simvastatin point and the ammonium salt point were not completely separated, and the size of the ammonium salt point could not be determined. <br><br>The main reason for this deviation is that the operator did not check the console after the TLC board operation in the morning, and forgot to put the lid of the developing agent exhibition cylinder back, causing the developing agent in the exhibition cylinder to volatilize, thereby reducing the polarity of the developing agent. Eventually, the ammonium salt point and simvastatin in the sample could not be separated and did not meet the requirements. <br><br>This deviation belongs to the operator's forgetting to replace the cover of the exhibition cylinder during the TLC detection process, resulting in the evaporation agent in the exhibition cylinder evaporating. It belongs to the operation deviation of the personnel, and there is no problem with the sample itself. Replacing the developing agent in the exhibition tank, the TLC spotting was re-used at 16:49 on July 29, 2019. The ammonium salt content is less than 1%, which meets the process requirements and the next step can be performed. <br><br>1. The original test TLC spot board shall be invalid and retained, and the test result shall be retested as is and the test report shall be issued. <br>2. Mark on the cover of the exhibition tank (cover it in time), and use the deviation as an example to train the post operator, emphasizing that the operator should check the operation platform after the test and cover it in time.

2019.07.29日16:38，209车间王望娥在Y53幢二楼在对辛伐他汀3011-B2190751-CP批次的环化反应液3011-B2190751-HH进行TLC检测时，发现样品爬板发生异常，辛伐他汀3011-B2190751-CP批次爬板显色后，辛伐他汀点和铵盐点未完全分离，无法判断铵盐点大小。 <br><br>本偏差主要原因为操作人员在上午TLC点板操作后，未检查操作台，忘将展开剂展缸的盖子盖回来，导致展缸中的展开剂挥发，从而使展开剂的极性变小。最终导致样品中的铵盐点和辛伐他汀无法分离、不符合要求。 <br><br>该偏差属于TLC检测过程中操作人员忘将展缸的盖子盖回，导致展缸内展开剂挥发，属于人员操作偏差，样品本身不存在问题。更换展缸内展开剂，已于2019年07月29日16：49分用原样重新进行TLC点板，铵盐含量少于1%，符合工艺要求，可进行下一步操作。<br><br>1.原检测TLC点板作废保留，以原样复测结果并出具检测报告。<br>2.在展缸的盖子上标识（及时盖回），并以此次偏差为案例对岗位操作人员进行培训，强调检测结束后要检查操作台，及时盖回盖子。

At 16:38209 on July 29, 2019, Wang Wange was on the second floor of building y53 when TLC detection was carried out for batch 3011-b2190751-hh of cycloreaction solution of simvastatin 3011-b2190751-cp, it was found that the sample climbing board was abnormal. After the color of batch 3011-b2190751-cp climbing board, simvastatin point and ammonium salt point were not completely separated, so the size of ammonium salt point could not be determined.<br>The main reason for this deviation is that the operator did not check the operation platform after the TLC point board operation in the morning, and forgot to cover the cover of the developing agent cylinder back, resulting in the volatilization of the developing agent in the cylinder, thus reducing the polarity of the developing agent. Finally, the ammonium salt point and simvastatin in the sample could not be separated and did not meet the requirements.<br>This deviation is due to the operator's forgetting to cover the cover of the spreading cylinder during TLC detection, which results in the volatilization of the developing agent in the spreading cylinder. It is due to the operator's operation deviation, and the sample itself has no problems. Replace the developing agent in the expanding cylinder. TLC spot plate has been re conducted with the original sample at 16:49 on July 29, 2019. The content of ammonium salt is less than 1%, which meets the process requirements. The next operation can be carried out.<br>1. The original TLC spot plate shall be discarded and retained, and the retest results shall be based on the original samples and the test report shall be issued.<br>2. Mark the cover of the display cylinder (cover it back in time), and take this deviation as an example to train the post operators, emphasizing to check the operation platform after the test, and cover it back in time.<br>