本偏差属于人为差错引起，由于缺少标准品数据，4015-A200904/

This deviation is caused by human error. Due to the lack of standard product data, the 8-oxo-B1a content of 4015-A200904/5 6M batch of stability samples cannot be calculated. The project's map data is invalidated and retained, and the original sample package needs to be re-tested for 8-oxygen. Generation-B1a project; the results of the content and related substances tested at the same time are not affected, and this deviation has no effect on the stability trend study. Reviewing the experiments conducted by the experimenter Huang Hong since he took office, there was no deviation caused by similar leakage of the standard solution, so the quality risk of the products and batches tested by the employee in the early stage was controllable. The CAPA was formulated for this deviation: Training related personnel H0-AM-10025-R02 High Performance Liquid Chromatography Inspection Record 00 version of the pre-inspection checklist of the inspectors before sampling, emphasizing the need to verify the correctness of the solution preparation steps.

The deviation was caused by human error. Due to the lack of standard data, the content of 8-oxo-b1a in 4015-a200904 / 56m batch of stability samples could not be calculated. The atlas data of this project was invalid and retained, and the original sample package was needed to re detect 8-oxo-b1a project; At the same time, the results of content and related substances were not affected, and this deviation had no effect on the stability trend study. After reviewing the experiments of Huang Hong, the experimenter, no similar deviation caused by standard solution leakage was found, so the quality risk of products and batches detected by the experimenter in the early stage was controllable. For this deviation, CAPA was formulated: training of relevant personnel, h0-am-10025-r02 high performance liquid chromatography test record, version 00, self inspection list of inspectors before sample injection, emphasizing the need to check and confirm whether the steps of solution preparation are correct.<br>

This deviation is caused by human error. Due to the lack of standard data, the results of 8- oxo -B1a content in 4015-A200904/5 6M batch of stability samples cannot be calculated. The map data of this project is invalid and reserved, so it is necessary to re-test the 8- oxo -B1a project with the original package. At the same time, the test results of content and related substances are not affected, and this deviation has no influence on stability trend research. After reviewing the experiments conducted by Huang Hong, an experimenter, no deviation caused by the leakage of standard solution was found, so the quality risks of products and batches detected by this employee in the early stage were controllable. In view of this deviation, CAPA: train relevant personnel, H0-AM-10025-R02, Inspection Record of High Performance Liquid Chromatography, version 00, and check the correctness of the solution preparation steps.