2021年03月18日下午15：45分，API QA 沈晓军在整理年报

At 15:45 pm on March 18, 2021, when API QA Shen Xiaojun compiled the annual report data, he found that there was a deviation in the annual report D-TZ-05AC-21001 follow-up investigation handling form and investigation report, so he immediately checked the CAPA summary table and found the deviation The relevant CAPA has not been entered in the summary table, and the approval date of the deviation is February 22, 2021. According to the H0-SOP-71008 Corrective and Preventive Measures Management Procedures, the CAPA notification and entry time limit has been exceeded. <br><br><br>The root cause of this deviation is due to the tight time and heavy workload of the annual report after the year. QA engineers focus on the preparation of the annual report, and accidentally add the deviation handling table and the investigation report to the annual report data, and mistakenly believe that the deviation has been submitted. The CAPA administrator failed to conduct further communication and confirmation, which resulted in the failure to find and archive the deviation questionnaire in time and hand over the relevant CAPA to the CAPA administrator, which eventually caused the CAPA entry date to exceed the time limit required by the program. <br><br><br>Continued in the "Impact Assessment and Risk Assessment" column on the right: This deviation is caused by the negligence of the personnel to cause the CAPA to fail to enter the date beyond the time limit required by the procedure, and has no impact on product quality, and does not involve product release.

At 15:45 p.m. on March 18, 2021, API QA Shen Xiaojun found that the deviation d-tz-05ac-21001 follow-up investigation and treatment form and investigation report were included in the annual report when sorting out the annual report data, so he immediately inquired the CAPA summary table and found that the deviation related CAPA was not entered in the summary table, and the approval date of the deviation was February 22, 2021, according to the provisions of h0-sop-71008 management procedure for corrective and preventive measures, The notice and entry time limit of CAPA has been exceeded.<br>The root cause of this deviation is that the annual report preparation time is tight and the workload is heavy. QA engineers focus on the annual report preparation work, carelessly bring the deviation processing table and investigation report into the annual report data, mistakenly think that the deviation has been handed over to the CAPA administrator, without further communication and confirmation, As a result, the deviation questionnaire was not found and filed in time, and the relevant CAPA was handed over to the CAPA administrator, which eventually led to the entry date of CAPA exceeding the time limit specified in the procedure.<br>Continue the column of "impact assessment and risk assessment" on the right: this deviation is due to the negligence of personnel, which leads to the failure of the entry date of CAPA to exceed the time limit specified in the procedure, and has no impact on the product quality and does not involve the product release.<br>

At 15: 45 pm on March 18, 2021, API QA Shen Xiaojun found that the annual report contained deviation D-TZ-05AC-21001 follow-up investigation treatment table and investigation report, and immediately inquired CAPA summary table and found that the CAPA related to the deviation was not entered in the summary table, and the approval date of the deviation was February 22, 2021, according to H0-SOP-71008.The root cause of this deviation is due to the tight preparation time and heavy workload of the annual report after the year. The QA engineer focused on the preparation work of the annual report, inadvertently and accidentally carried the deviation treatment table and investigation report into the annual report data, and mistakenly thought that the deviation had been handed over to the CAPA administrator, without further communication and confirmation. As a result, the deviation questionnaire was not found and filed in time and the relevant CAPA was handed over to the CAPA administrator, which eventually led to the CAPA entry date exceeding the time limit specified in the procedure.Continued from the column of "Impact Assessment and Risk Assessment" on the right: this deviation is that the CAPA failed to enter the date beyond the time limit specified in the procedure due to personnel negligence, which has no impact on product quality and does not involve product release.