2019.06.04日17：30，分析员杨满霞在对洛伐他汀回收乙酸乙酯

At 17:30 on 2019.06.04, after analyzing the sequence injection of ethyl acetate YSYZ-3020-190604 for lovastatin recovery, analyst Yang Manxia looked at the sequence table and found that both the standard solution and the sample solution injection vials were input at 101 , There is an input error. <br><br>This deviation is caused by the wrong input of the sample solution into the vial when the analyst created the new sequence table, the self-inspection before the injection, and the review by the reviewer. <br><br>This deviation was caused by the analyst inputting the wrong sample solution vial when creating the sequence table. The self-inspection and the reviewer's review before the sample injection were not in place, which was a human error. Modify the position of the sample solution in the sequence table from 101 to 102. Re-inject the standard solution and sample solution under other original conditions, the peak is normal, and lovastatin recovers ethyl acetate The result is 98.6%, which meets SOP requirements ≥95%. No impact on production quality assessment. <br><br>1. Obsolete the error map. After re-evaluating the suitability of the instrument system, inject lovastatin and recover ethyl acetate YSYZ-3020-190604 for testing, and issue a testing report. <br>2. Train analysts and reviewers on the H3-SOP-72027 analysis raw data recording and processing management procedures and H0-SOP-71031 second-person review and audit management procedures training, emphasizing the initial self-examination of the analyst before gas sampling Checklists and reviewers review the checklist before sampling. Analysts and reviewers must complete the item-by-item review according to the SOP before they can sign and date the records.

2019.06.04 at 17:30, analyst Yang Manxia in the Lovastatin recovery of ethyl acetate YSYZ-3020-190604 sequence after the sample, look at the sequence table, found that the standard solution and sample solution into the sample vial position input is 101, there is an input error. <br><br>This deviation is the analyst in the new sequence table when the sample solution into the sample vial position input error, before the sample did not go through self-examination and the reviewer review did not come into place, is a personnel error. <br><br>This deviation for the analyst in the new sequence table when the sample solution into the sample vial position input error, before the sample did not go through self-examination and the reviewer review did not lead to, is a personnel error. The position of the sample solution in the modified sequence list was changed from 101 to 102, and in other cases where the original conditions remained unchanged, the standard solution and the sample solution were re-sampled, the peak was normal, and the result of the recovery of ethyl acetate YSYZ-3020-190604 was 98.6%, in line with The SOP requirement s.95%. No impact on production quality assessment.<br><br>1. The error map is invalidated. The adaptability of the instrument system was re-evaluated and then sampled by Lovastatin to recover ethyl acetate YSYZ-3020-190604 for testing and a test report.<br>2. Training of analysts and reviewers in the analysis of raw data records and processing management procedures and H0-SOP-71031 second-party review and audit management procedures, emphasizing that for the gas-phase advanced pre-analyst's preliminary self-examination list and the reviewer's pre-review list, the analyst must be reviewed according to SOP item-by-item completion before signing and date.

At 17:30 on June 4, 2019, analyst Yang manxia looked at the sequence table after the end of sequence injection of ysyz-3020-190604 for the recovery of ethyl acetate from lovastatin, and found that the position input of standard solution and sample solution injection vials was 101, with input error.<br>This deviation is caused by the analyst's wrong input of the position of the sample solution injection vial when creating a new sequence table, no self-examination before injection, and the reviewer's review is not in place, which is a human error.<br>This deviation is caused by the analyst's wrong input of the sample solution injection vial position when creating a new sequence table. Before injection, it was not self checked and rechecked by the reviewer, which is a mistake of personnel operation. The position of sample solution in the modified sequence table was changed from 101 to 102. Under the condition that other original conditions remained unchanged, the standard solution and sample solution were re injected, and the peak was normal. The recovery result of ethyl acetate ysyz-3020-190604 by lovastatin was 98.6%, which met the requirements of SOP ≥ 95%. No impact on production quality assessment.<br>1. Cancel and retain the error map. After reevaluating the adaptability of the instrument system, inject lovastatin to recover ethyl acetate ysyz-3020-190604 for testing, and issue a test report.<br>2. Train the analysts and reviewers on h3-sop-72027 analysis original data record and processing management procedure and h0-sop-71031 second person review and audit management procedure. Emphasize that the analysts' preliminary self inspection list and reviewers' pre injection review list before gas phase injection. The analysts and reviewers can sign on the record and indicate the date only after the completion of one by one review according to SOP.<br>