本偏差发生的直接原因是检测人员和生产人员对精制品的检测结果复核不到位，

The direct cause of this deviation is that the test personnel and production personnel did not check the test results of the refined products in place. The fundamental reason is that the analyst did not carefully check the intermediate quality standards during the result judgment, which led to the result judgment error, which is a human cause. <br><br>1. Check and analyze all products analyzed by Fang Ping 3 months before the date of the result judgment, and found no error in the result judgment. 2. The verification analyst Li Yaya's review of this deviation involves the review data of the first 3 months from the batch date, and no error was found in the review of the results. 3. The workshop operator's review of the test results of letrozole (B process south line) refined products has not occurred in the past three years. 4. According to the OOS-API-KZLH-19007 letrozole (process B) OOS survey, the result shows that the single unknown impurity of 1117-C191001 letrozole refined product does not meet the quality standards. The root cause is that the mobile filter is sealed Poor performance leads to incomplete degassing, and bubbles are generated during the liquid phase gradient mixing process, regardless of product quality. 5. The batch number of the letrozole product involved in this deviation is 1117-C191001, and the detection standard is YBH standard. The QC personnel conducted liquid phase detection on the batch of samples on November 11, 2019. The detection patterns are normal, and the single impurity detection result is < 0.02%, in line with quality standards, this deviation has no effect on the quality of the finished product. <br><br>CP-TZ-API-D-TZ-API-IP-19044- <br>20001: Link deviation, OOS number, and a brief description in the original test record of 1117-C191001 letrozole refined products. <br>CP-TZ-API-D-TZ-API-IP-19044- <br>20002: Anti-tumor IPC personnel were trained in H3-QS-20055 "Letrozole (Process B) Intermediate Quality Standards", emphasizing the requirements of each intermediate . <br>CP-TZ-API-D-TZ-API-IP-19044- <br>20003: Anti-tumor IPC personnel were trained in H0-SOP-72047 "Laboratory Review Audit Management Procedures", emphasizing that the review content must include a statement of the final result And includes comparison with established standards.<br>CP-TZ-API-D-TZ-API-IP-19044- <br>20004: Train the relevant personnel of building Y38 on the production operation regulations of H3-MPD-10329-07 letrozole (south line of B process), emphasize: review The test results of each intermediate need to be checked item by item.

The direct cause of this deviation is that the test personnel and production personnel of the refined products test results review is not in place, the root cause is that the analyst in the results of the judgment did not carefully check the intermediate quality standards, resulting in the results of error, belongto on human causes.<br><br>1. Verification analyst Fang Ping in the results of the first 3 months of the date of analysis of all products, did not find the results of the error. 2. Verification analyst Li Yaya in the review of this deviation involving the batch of the first 3 months of the review data, did not find the results of the review error. 3. The error of review of the test results of fine products of the workshop operator has not occurred in the last three years. 4. According to OOS-API-KZLH-19007 to querzine (B process) OOS survey, the results show that 1117-C191001 to querzine concentrate siculs a single unknown impurity does not meet quality standards due to the filter flow phase of the filter bottle seal ingressation is poor, resulting in incomplete degassing, in the liquid phase gradient mixing process to produce bubbles, not related to product quality. 5. This deviation involves the batch number of the finished product of 1117-C191001, the test standard is YBH standard, QC personnel in 2019.11.11 on the batch of samples for liquid phase testing, detection map is normal, a single impurity test results 0.02%, in line with quality standards, this deviation has no effect on the quality of its finished product.<br><br>CP-TZ-API-D-TZ-API-IP-19044-<br>20001: Link deviation, OOS number, and a brief description in the original record of the inspection of the 1117-C191001 to the original record of the toequer refined products.<br>CP-TZ-API-D-TZ-API-IP-19044-<br>20002: Anti-tumor IPC personnel to H3-QS-20055 "Toquepyrium (B process) intermediate quality standards" training, emphasizing the limits of each intermediate requirements.<br>CP-TZ-API-D-TZ-API-IP-19044-<br>20003: Anti-tumor IPC personnel trained h0-SOP-72047 "Laboratory Review Audit Management Procedure", emphasizing that the review content must include a statement of the final result, and include comparison with established standards.<br>CP-TZ-API-D-TZ-API-IP-19044-<br>20004: Y38 related personnel h3-MPD-10329-07 to querthorium (B process south line) post production operation procedures training, emphasizing: review the test results of the intermediates need to carry out article-by-article verification of the testing items.

The direct cause of this deviation is that the inspection results of the refined products are not reviewed properly by the inspection personnel and the production personnel, and the root cause is that the analyst did not carefully check the quality standards of the intermediates during the result judgment, resulting in the result judgment error, which belongs to the human reason.<br>1. Check all products analyzed by the analyst Fang Ping in the first three months since the date of result determination, and no result determination error is found. 2. Li Yaya, the inspection analyst, rechecked the recheck data of the first three months since the date of the batch involved in the deviation, and found no error in the recheck result. 3. The operator of the workshop rechecked the test results of letrozole (south line of B process) precision products without any error in the past three years. 4. According to oos-api-kzlh-19007 letrozole (B process) OOS investigation, the result shows that the root cause of the single unknown impurity of 1117-c191001 letrozole refined product not meeting the quality standard is the poor sealing of the suction filtration bottle of the filtration mobile phase, resulting in incomplete degassing and the generation of bubbles in the liquid phase gradient mixing process, which has nothing to do with the product quality. 5. The batch number of letrozole products involved in this deviation is 1117-c191001, and the test standard is ybh standard. QC personnel conducted liquid phase test on the samples of this batch on November 11, 2019, and the test atlas was normal. The test result of single impurity is less than 0.02%, meeting the quality standard. This deviation has no impact on the product quality.<br>CP-TZ-API-D-TZ-API-IP-19044-<br>20001: link deviation, OOS number in the original inspection record of 1117-c191001 letrozole refined products, and give a brief description.<br>CP-TZ-API-D-TZ-API-IP-19044-<br>20002: anti tumor IPC personnel were trained in h3-qs-20055 "quality standard for letrozole (B process) intermediates", emphasizing the limit requirements for each intermediate.<br>CP-TZ-API-D-TZ-API-IP-19044-<br>20003: anti tumor IPC personnel were trained in h0-sop-72047 "laboratory review and audit management procedure", emphasizing that the review content should include the statement of the final results and the comparison with the established standards.<br>CP-TZ-API-D-TZ-API-IP-19044-<br>20004: train the relevant personnel of building Y38 on the post production and operation procedures of h3-mpd-10329-07 letrozole (south line of process B), emphasizing that the test items shall be checked one by one when checking the test results of each intermediate.