1) 本偏差属于设备设施原因引起，由于色谱柱出现主峰分叉，实验结果无法

1) This deviation is caused by equipment and facilities. Because the main peak of the chromatographic column is bifurcated, the experimental results cannot be calculated, the map data is invalid, and the original sample package needs to be re-tested. This deviation has no effect on the product quality evaluation. 2) Check the A0727# chromatographic column in the past two years, only once tested the related substance items of sterile imipenem foreign registration standards, and the results normally met the quality requirements; at the same time, the other products tested did not show the abnormality of the main peak bifurcation, the system is applicable The performance meets the requirements, so the experimental results detected by the chromatographic column in the early stage are valid and risk-free. 3) The chromatographic column number A0727# used for this deviation is no longer suitable for the detection of sterile imipenem foreign registered standard related substances, and the column usage record and its cover note that the column is not suitable for sterile imipenem Foreign registration method related substance item testing. 4) In order to avoid recurrence of similar incidents, the training of liquid-phase personnel using this deviation as a case emphasizes: The detection of related substances in the foreign registration method of sterile imipenem requires special chromatographic columns and cannot be mixed with other products.

1) The deviation is caused by equipment and facilities. Because of the main peak bifurcation of the chromatographic column, the experimental results cannot be calculated, the atlas data is invalid, and the original sample package is required to re test. The deviation has no effect on the product quality evaluation. 2) The results of the test showed that only one time the aseptic imipenem foreign registration standard related substances were detected in a0727 column in recent two years, and the results were in line with the quality requirements; At the same time, there is no abnormal peak bifurcation in other products, and the system applicability meets the requirements. Therefore, the experimental results detected by the column in the early stage are effective and risk free. 3) The column No. a0727 used for this deviation is not applicable to the test of relevant substances in the aseptic imipenem foreign registration standard. The use record and the cover note of the column are not applicable to the test of relevant substances in the foreign registration method of aseptic imipenem. 4) In order to avoid similar events, the training for liquid phase personnel based on this deviation emphasizes that special chromatographic column is required for the testing of substances related to aseptic imipenem foreign registration method, and it cannot be mixed with other products.<br>

My name is Huang Hongsheng. I am 39 years old. My favorite interests are watching art exhibitions, music, movies and video games.