本偏差主要由于卡氏容量水分测定检验原始记录未按产品进行单独划分保存，化

本偏差主要由于卡氏容量水分测定检验原始记录未按产品进行单独划分保存，化验员陆启明开具报告单时未依据利奈唑胺中间体质量标准进行逐条核对，致使在未获得所有检测结果时就输出结果并在样品检测台帐上登记完成时间，导致化验员张海晶误认为该批样品已完成所有项目的检测，故未在2019年12月11日当天对该批样品进行水分检测。复核者王丽颖未复核到位，岗位负责人包海建未严格按照H3-SOP-61035《车间物料管理程序》规定仔细核对检验报告单，导致利奈唑胺芳胺物在水分项目未检测时就投入下步生产。属于人为和方法原因。<br><br>1. 2019年12月15日，IPC对2081-191203批利奈唑胺芳胺物的水分进行检测，水分结果为0.06%（标准：水分≤1.0%），检测结果合格，符合利奈唑胺中间体质量标准要求，以该结果重新出具检测报告单。2. 2081-191203批利奈唑胺芳胺物于偏差发现时已生产至粗品，后续工序的三光气反应液、缩合反应液、缩合物、肼解反应液、乙酰化反应液、粗品检测均符合利奈唑胺中间体质量标准要求。该偏差的发生对产品质量无影响。3. 2018年度共生产利奈唑胺共10批，2019年度到目前为止共生产利奈唑胺共3批，所有中间体均在下一步生产前进行检测，结果均合格。4. 排查化验员陆启明近2年的所有检验报告单，均在所有项目检测完成后出具检测报告单。排查化验员王丽颖近2年的所有检验报告单复核结果，均无异常。排查岗位负责人近2年放行的中间体，所有项目均在放行前检测合格。<br><br>CP-TZ-API-D-TZ-API-11LI-19001-20001: Testing of 2091-191203 batches of linezolid aromatic amines moisture items. CP-TZ-API-D-TZ-API-11LI-19001-20002: Add moisture test results to the test report form for linezolid arylamines in 2081-191203, correct the report time, and correct the completion of inspection in the sample receiving account time. CP-TZ-API-D-TZ-API-11LI-19001-20003: H3-SOP-61035 "Workshop Material Management Procedure" and H3-SOP-61019 "Pre-production Preparation and Inspection Management" for the person in charge of the post Bao Haijian The retraining of "Procedure" emphasizes the need to carefully check the inspection report according to quality standards. CP-TZ-API-D-TZ-API-11LI-19001-20004: The original records of the determination of the water content of the Kjeldahl volume are separately distinguished according to the product. CP-TZ-API-D-TZ-API-11LI-19001-20005: Training of analysts Lu Qiming, Wang Liying and Zhang Haijing in H3-SOP-61081 "IPC Laboratory Sample Inspection Management Procedure", emphasizing: After the inspection results of the project have been verified by the second person, the inspection report shall be issued. The contents of the review include: checking whether the project is complete, whether the method used in each project is correct, and whether the experimental records are filled in completely and correctly.

This deviation is mainly due to the Kars capacity moisture determination test original record is not separately divided and saved by product, laboratory inspector Lu Qiming issued a report sheet did not follow the Linaethine intermediate quality standards for article-by-article check, resulting in the output results on the failure to obtain all the test results and the sample test ingress account registration completion time, resulting in laboratory inspector Zhang Haijing mistakenly believe that the batch of samples has completed the testing of all items, so the same day the sample was not tested on the same day. Reviewer Wang Liying did not review in place, the position leader Bao Haijian did not strictly in accordance with H3-SOP-61035 "workshop material management procedures" carefully check the inspection report sheet, resulting in linamine aphasiamine in the moisture project did not detect when put into the next step of production. It's for human and methodological reasons.<br><br>1. On December 15, 2019, IPC tested the moisture of 2081-191203 batches of linamine aramids, the moisture result was 0.06% (standard: moisture s.1.0%), the test results were qualified, and the results met the requirements of the Linaemine intermediate syme quality standards, and the test report was reissued with the results. 2. 2081-191203 batch of linamine amine aramids have been produced to crude products at the time of deviation detection, and the three-light gas reaction fluid, the compact reaction fluid, the compactor, the solution fluid, the acetylation reaction fluid, and the crude product test all meet the quality standards of linamine intermediates. The occurrence of this deviation has no effect on product quality. 3. A total of 10 batches of linamine were produced in 2018 and 3 batches of linamolide have been produced so far in 2019, all intermediates were tested before the next production, and the results were qualified. 4. All inspection reports for the laboratory inspector Lu Qiming in the past 2 years are issued after the completion of all items testing. There were no anomalies in the review results of all inspection reports by inspector Wang Liying in the past 2 years. Check the post responsible for nearly 2 years release of intermediates, all items are in the release before the detection of qualified.<br><br>CP-TZ-API-D-TZ-API-11001-20001: Detection of the 2081-191203 linamine aphoramine moisture project. CP-TZ-API-D-TZ-API-11LI-19001-20002: Add moisture detection results, correct report time, and correct inspection completion time in the sample receiving desk in 2081-191203 batch of Linaeamine aphorain inspection report. CP-TZ-API-D-TZ-API-11001-20003: Retraining of the H3-SOP-61035 Workshop Material Management Procedure and H3-SOP-61019 Pre-Production Preparation and Inspection Management Procedure for the position-in-charge Bao Haijian, emphasizing the need to carefully check the report sheet in accordance with quality standards. CP-TZ-API-D-TZ-API-11LI-19001-20004: The original record of the Kars capacity moisture determination test is individually distinguished by product. CP-TZ-API-D-TZ-API-11001-20005: Training of analysts Lu Qiming, Wang Liying, Zhang Haijing H3-SOP-61081 IPC Laboratory Sample Inspection Management Procedure, emphasizing: After obtaining the results of all projects and reviewing the accuracy of the second person, the inspection report is issued. The contents of the review are: check whether the project is complete, the method used in each project is correct, whether the experimental record is complete, correct and so on.

This deviation is mainly due to the original records of the measurement and inspection of the water content in the Karl Fischer scale are not separately classified and kept according to the products, and the analyst Lu Qiming did not check one by one according to the quality standard of the intermediate of linezolid when he issued the report, so that when all the test results are not obtained, the output results and the completion time are registered in the sample test account, leading to the analyst Zhang Haijing mistaking the batch of samples The test of all items has been completed, so the moisture test of this batch of samples was not carried out on December 11, 2019. Wang Liying, the reviewer, did not recheck in place, and Bao Haijian, the person in charge of the post, did not carefully check the inspection report in strict accordance with the provisions of h3-sop-61035 workshop material management procedure, which led to the next production of linezolid aromatic amines when the moisture items were not tested. It belongs to human and method reasons.<br>1. On December 15, 2019, IPC tested the water content of 2081-191203 batches of linazolamide aromatic amines, and the water content result was 0.06% (standard: water content ≤ 1.0%). The test result was qualified, meeting the requirements of linazolamide intermediate quality standard, and a new test report was issued based on the result. 2. 2081-191203 batches of linazolamide aromatic amines have been produced to the crude product when the deviation is found. The following process's triphosgene reaction solution, condensation reaction solution, condensation product, hydrazinolysis reaction solution, acetylation reaction solution and crude product detection all meet the quality standard requirements of linazolamide intermediate. The deviation has no effect on the product quality. 3. A total of 10 batches of linezolid were produced in 2018, and 3 batches of linezolid have been produced so far in 2019. All intermediates were tested before the next production, and the results were qualified. 4. For all the inspection reports of Lu Qiming, the screening analyst in the past two years, the inspection report shall be issued after all the items are tested. All the recheck results of the inspection reports of Wang Liying in the past two years were normal. For the intermediates released by the person in charge of the screening post in recent 2 years, all the items are qualified before release.<br>Cp-tz-api-d-tz-api-11li-19001-20001: test the moisture content of 2081-191203 batches of linazolamide aromatic amines. Cp-tz-api-d-tz-api-11li-19001-20002: add moisture test results, correct the report time, and correct the inspection completion time in the sample receiving account in the batch 2081-191203 linazolamide aromatic amine inspection report. Cp-tz-api-d-tz-api-11li-19001-20003: retraining the person in charge of the post, Bao Haijian, on h3-sop-61035 workshop material management procedure and h3-sop-61019 pre production preparation and inspection management procedure, emphasizing the need to carefully check the inspection report according to the quality standard. Cp-tz-api-d-tz-api-11li-19001-20004: the original records of the measurement and inspection of the moisture content of the kappa capacity shall be distinguished separately according to the products. Cp-tz-api-d-tz-api-11li-19001-20005: train analysts Lu Qiming, Wang Liying and Zhang Haijing on h3-sop-61081 management procedure for sample inspection in IPC laboratory, emphasizing that the inspection report shall be issued after the inspection results of all items are obtained and verified by the second person. The review contents include: whether the inspection items are complete, whether the methods used for each item are correct, whether the experimental records are complete and correct, etc.<br>