该偏差为人员疏忽及文件对于色谱柱注意事项信息未备注导致标准回针不符合要

This deviation is due to the negligence of personnel and the lack of remarks in the document for the precautions of the chromatographic column. The standard back needle does not meet the requirements. The product quality of imipenem (calibrated batch number 2065011N210508, after calibration is 2101) will not be affected, and the E0085 chromatogram must be replaced The column is recalibrated and the results are reported as retest.

The deviation was due to the negligence of personnel and the lack of notes on the column information in the document, which resulted in the standard return needle not meeting the requirements. The product quality of imipenem (the calibration batch number was 2065011n210508, and the batch number was 2101 after calibration) was not affected. The e0085 column should be replaced for recalibration, and the retest results should be reported.<br>

The deviation is caused by negligence of personnel and omission of notes on chromatographic column information in the document, which leads to the failure of standard needle return. The product quality of imipenem (the calibrated batch number is 2065011N210508, and the calibrated batch number is 2101) is not affected, so it is necessary to replace E0085 chromatographic column for recalibration and report the retest results.