2019.09.03日，实验员李天威在ICE3500型原子吸收光谱仪上

On 09.03.2019, when testing the Pd content of batches of linezolid 2081-190601, 2081-190602, and 2081-190603 on the ICE3500 atomic absorption spectrometer, the experimenter Li Tianwei found that the standard 5 back test did not meet the acceptance standard (standard 5 signal value Is ± 20%). <br><br>This deviation is due to the fact that the experimenters are not familiar with the parameter settings of the ICE3500 atomic absorption spectrometer (a total of 3 tests in 2019). After the PinAAcle 900T atomic absorption spectrometer is often used (the system standard and the backtest standard are the same measuring cup), it only falls The habit of a standard solution, when using the ICE3500 atomic absorption spectrometer, habitually only poured a standard solution, and did not pour back the test solution (the test solution was not placed in the corresponding position on the autosampler), resulting in The syringe is empty, and the backtest result is abnormal. <br><br>This deviation is caused by the experimenter's inadequate experimental operation process, which has nothing to do with the quality of the product itself, and the product quality is confirmed to be free of risks. <br>The linezolid 2081-190601, 2081-190602, and 2081-190603 spectra were discarded and reserved. The response values ​​of the spectrum were basically the same as the retest of the original solution (see Annex 2 of the investigation report). Test Report. <br>This experiment is man-made, and has nothing to do with the performance of ICE3500 atomic absorption spectrometer, so there is no risk for the samples previously tested on this instrument. <br>After investigating the experiment carried out by the experimenter on the ICE3500 atomic absorption spectrometer in the past two years, no errors similar to the unreturned solution have occurred, so the quality risk of the products and batches detected by the experimenter in the early stage can be controlled. <br><br>1. Retain the original test data of 2081-190601, 2081-190602, 2081-190603, and re-test linezolid 2081-190601, 2081-190602, 2081-190603 and the corresponding standard stock solutions.<br>2. Training related personnel H0-SOP-72046 laboratory sample inspection process version 03, emphasizing that before testing, it is necessary to check whether the equipment used is normal, the relevant information of the testing product such as product name, batch number is entered correctly, the method used Whether it is accurate, whether the injection sequence setting and injection vial placement are correct.

On 2019.09.03, experimenter Li Tianwei detected Linaethamine 2081-190601, 2081-190602, 2081-190603 batch Pd content itemon on the ICE3500 atomic absorption spectrometer, and found that the standard 5 echo test did not meet the accepted standard (standard 5 signal value is 20%). <br><br>This deviation is due to the experimenter's lack of familiarity with the ICE3500 atomic absorption spectrometer parameters (3 tests in 2019), after regular use of the PinAAcle 900T atomic absorption spectrometer (system standards and echo standards are the same Volume cup) to form a habit of reversing only one standard solution, when using ICE3500 atomic absorption spectrometer, habitually only poured a standard solution, without retesting the solution (not placed in the corresponding position on the automatic sampler), Causes the sample needle to vacuum and the backtest results are abnormal.<br><br>This deviation is due to the experimenter experimental operation process is not careful, and the quality of the product itself is not related, product quality has been confirmed that there is no risk.<br>This linamine 2081-190601, 2081-190602, 2081-190603 map invalid, the map response value and the original liquid retest (see investigation report annex 2) map is basically the same, the original map is for reference only, to the original liquid retest results issued test report.<br>This experiment is man-made, and ICE3500 atomic absorption spectrometer itself has nothing to do with performance, so there is no risk to the samples detected on the instrument in the early stage.<br>After checking the experimenter in the last 2 years in ice3500 atomic absorption spectrometer experiments, there have been no similar to the non-rewind solution errors, so the early test by the experimenter product and batch quality risk can be controlled.<br><br>1. The original test data of 2081-190601, 2081-190602, 2081-190603 are retained, and the original test data of linamolamine 2081-190601, 2081-190602, 2081-190603 and the corresponding standard original liquid are measured.<br>2. Training of relevant personnel H0-SOP-72046 laboratory sample inspection process 03 version, emphasizing that before testing to check whether the instrument used is normal, the inspection of product information such as product naming, lot number input is correct, the method used is accurate, the sample sequence setting and sample bottle placement location is correct.

On September 3, 2019, when Li Tianwei, an experimenter, tested the Pd content of linezolid 2081-190601, 2081-190602 and 2081-190603 batches on ice3500 atomic absorption spectrometer, he found that the back test of standard 5 did not meet the acceptance standard (the signal value of standard 5 was ± 20%).<br>This deviation is due to the fact that the experimenter is not familiar with the parameter setting of ice3500 atomic absorption spectrometer (3 tests in 2019), and pinaacle is often used After the 900t atomic absorption spectrometer (the system standard and the back test standard are the same measuring cup), the habit of pouring only one standard solution is formed. When the ice3500 atomic absorption spectrometer is used, only one standard solution is poured habitually, but the back test solution is not poured (the back test solution is not placed on the corresponding position of the automatic sampler), resulting in the injection needle being empty and the back test result being abnormal.<br>This deviation is caused by the careless operation of the experimenter, which has nothing to do with the quality of the product itself, and the product quality is confirmed to be free of risks.<br>The atlas of linezolid 2081-190601, 2081-190602 and 2081-190603 are invalid and reserved. The response value of the atlas is basically the same as that of the original solution retest (see Appendix 2 of the investigation report). The original atlas is only for reference, and the test report is issued based on the results of the original solution retest.<br>This experiment is for human reason and has nothing to do with the performance of ice3500 atomic absorption spectrometer, so there is no risk for the samples detected on this instrument in the early stage.<br>After checking the experiment carried out by the experimenter on the ICE3500 atomic absorption spectrometer in recent 2 years, there was no similar error of not back testing the solution, so the product and batch quality risk detected by the experimenter in the early stage was controllable.<br>1. The original test data of 2081-190601, 2081-190602 and 2081-190603 were discarded and retained. The renazolam 2081-190601, 2081-190602, 2081-190603 and the corresponding standard stock solution were retested.<br>2. Train relevant personnel on h0-sop-72046 laboratory sample inspection process (version 03), emphasize to check and confirm whether the instrument used is normal, relevant information of the tested product, such as whether the product name, batch number input is correct, whether the method used is accurate, whether the injection sequence setting and injection vial placement position are correct before the test.