15：00，微生物一部IPC实验室分析员何琴琴在高效液相（编号：CAY

15:00, an IPC laboratory analyst He Qinqin microorganisms in HPLC (ID: CAY-WSW1-09) sample spectra processing of pravastatin sodium "3036-E1190403 a purified product" on the instrument, found Rt: 11.591 the peak occurs at the flat min. During sampling, He Qinqin found there may be small air bubbles into the injector, but the data has been collected, it can not be stopped. <br><br>The reason for this deviation occurs when the analyst He Qinqin manual injection, the sample "3036-E1190403 a purified product" inject injector, due to the air bubbles injected into the barrel, Rt: 11.591min flat peak at bubbles peak, regardless of the sample itself, has no effect on product quality. <br><br>The only variation relates to a sample of pravastatin sodium "3036-E1190403 a purified product", through investigation that, since the sample was injected manually when the analyst injector, due to the air bubbles injected into the barrel. After finding laboratory error correction re-testing results without exception, and as the result of test report issued. The bias had no effect on the production process and product quality. <br><br>1. void and retain sample "3036-E1190403 a purified product" in the initial test pattern. <br>2. After correction re-testing of liquid samples "3036-E1190403 once refined products" and thus test report issued. <br>3. In this case the deviation of the column, manual analysis of all the training phase H3-TM-22108 "10A / 20A Series HPLC protocol" version of the injector 03 Operating Details "is injected into the sample injection when the sample loop, in particular the need to observe the presence or absence of small bubbles into the syringe, prevent bubble injection. "

15：00，微生物一部IPC实验室分析员何琴琴在高效液相（编号：CAY-WSW1-09）仪器上处理普伐他汀钠样品“3036-E1190403一次精制品”的图谱时，发现Rt：11.591min处出现扁平峰。进样过程中，何琴琴发现可能有小气泡进入进样器，但数据已经采集，故不能停止。 <br><br>此偏差发生的原因是分析员何琴琴在手动进样时，将样品“3036-E1190403一次精制品” 注入进样器时，将气泡注入针筒内所致， Rt：11.591min处的扁平峰为气泡峰，与样品自身无关，对产品质量无影响。 <br><br>本次偏差仅涉及普伐他汀钠样品“3036-E1190403一次精制品”，通过调查发现，由于分析员手动将样品注入进样器时，将气泡注入针筒内所致。在找到实验室差错纠偏后重新检测的结果无异常，并以此结果出具检测报告。本次偏差对生产过程及产品质量无影响。 <br><br>1.作废并保留样品“3036-E1190403一次精制品”的初测图谱。<br>2.纠偏后对样品“3036-E1190403一次精制品”原液重新检测并以此出具检测报告。<br>3.以此偏差为案列，对全体液相分析人员培训H3-TM-22108 《10A/20A系列高效液相色谱仪操作规程》03版的手动进样操作细节“进样时将样品注入进样环时，需特别注意观察进样针有无小气泡，防止将气泡注入”。

15: When he Qinqin, an analyst of IPC Laboratory of No.1 Department of Microbiology, processed the atlas of "3036-e1190403 primary refined product" of pravastatin sodium sample on the high performance liquid phase instrument (No.: cay-wsw1-09), it was found that there was a flat peak at RT: 11.591min. During the injection process, he Qinqin found that there may be small bubbles entering the injector, but the data has been collected, so it cannot be stopped.<br>The reason for this deviation is that when analyst he Qinqin injected the sample "3036-e1190403 primary refined product" into the syringe, the bubble was injected into the syringe. The flat peak at RT: 11.591min is the bubble peak, which has nothing to do with the sample itself and has no effect on the product quality.<br>This deviation only involves the "3036-e1190403 primary refined product" of pravastatin sodium sample. According to the investigation, it is found that the gas bubble is injected into the syringe when the analyst manually injects the sample into the syringe. After finding out the error correction in the laboratory, the results of the retest are normal, and the test report is issued based on the results. This deviation has no effect on the production process and product quality.<br>1. Discard and retain the primary test Atlas of the sample "3036-e1190403 primary refined product".<br>2. After correction, retest the original solution of the sample "3036-e1190403 primary refined product" and issue the test report accordingly.<br>3. Take this deviation as a case, train all the liquid analysis personnel on the manual injection operation details of h3-tm-22108 operating procedures for 10A / 20A series high performance liquid chromatograph (version 03), "when injecting samples into the injection ring, pay special attention to observe whether there are small bubbles in the injection needle to prevent the injection of bubbles".