本次偏差是由于人员在修订批记录时，造成文件错误，从而导致操作员陈伟杰工

This deviation is due to file errors caused by personnel when revising the batch records, which caused the operator Chen Weijie to be unable to record the relevant operating parameters in the relevant position. Reported to QA immediately after spot discovery. Under the guidance of QA on-site at 13:50 on February 20, 2021, the employee has recorded this step in the blank space of the batch record. The data can be traced and the risk is small. This deviation batch is the first use of version 06 of H3-MPD-10351 "HS-25 Batch Production Record (300701)". It does not involve other batches and has no effect on other batches. Looking back over the past 24 months, HS-25 products have not experienced similar deviations, and the frequency and risk of such deviations are low.

This deviation is due to the file error caused by the personnel when revising the batch record, resulting in the operator Chen weijiegong unable to record the relevant operation parameters in the relevant position. Report to QA immediately after finding on site. Under the guidance of QA at 13:50 on February 20, 2021, the employee has recorded the operation in the blank space of batch record. The data is traceable and the risk is small. This deviation batch is the first use of version 06 of h3-mpd-10351 hs-25 batch production record (300701), which does not involve other batches and has no impact on other batches. In the past 24 months, no similar deviation occurred in hs-25 products, and the frequency and risk of such deviation were low.<br>

This deviation is due to the document error caused by the personnel revising the batch record, which leads to the failure of the operator Chen Weijie to record the relevant operation parameters in the relevant position. Immediately report it to QA after site discovery. At 13: 50 on February 20, 2021, under the guidance of QA site, the employee recorded the operation in this step in the blank space of batch record. The data can be traced back and the risk is small. This deviation batch is the first use of H3-MPD-10351 HS-25 Batch Production Record (300701), which does not involve other batches and has no impact on other batches. Looking back in recent 24 months, HS-25 products have not experienced similar deviations, and the frequency and risk of such deviations are relatively low.