2019.10.01日10.45，分析员李如斌在检测3020-E190

On 10.45, 2019.10.01, the analyst Li Rubin detected 3020-E190901-T lovastatin immersion application solution and found that when the sequence was carried out to the needle standard solution, the online workstation interface showed a gray error (gray is the offline indicator of the instrument module) The instrument aborted the injection. <br><br>This deviation may be due to the accidental interruption of network communication, which caused the instrument to stop sampling. <br><br>1. This deviation may be caused by the occasional abnormal interruption of network communication, which leads to the suspension of sampling, which has nothing to do with the quality of the product itself. <br>2. The test result of lovastatin 3020-E190901-T immersion application solution when the deviation occurs is 2523.1μg / ml. Under the original condition is unchanged, re-inject the standard solution and the sample solution, and obtain 3020- The result of the E190901-T immersion application solution was 2520.2 μg / ml, and the results of the two injections were in line with the SOP requirements ≤ 6000 μg / ml. This deviation has no effect on production quality assessment. <br><br>1. Obsolete the error map. <br>2. After re-evaluating the suitability of the instrument system, re-inject and test the 3020-E190901-T immersion application liquid and issue a test report. <br>3. Carry out a three-month follow-up observation of all the instruments on the network server of the Central Control Department of Microbiology to see if a similar situation occurs.

2019.10.01 10.45, analyst Li Rubin in the detection of 3020-E190901-T Lovastatin soaked application liquid, found that the sequence to the needle standard solution, the online workstation interface shows gray error (grey for the instrument module offline indicator), the instrument stopped into the sample. <br><br>This deviation may be due to an accidental interruption of network communication, resulting in the suspension of the instrument sample. <br><br>1. This deviation may be due to accidental abnormal interruption of network communication resulting in the suspension of the sample, and the quality of the product itself is not related.<br>2. Lovastatin 3020-E190901-T immersion sleeve liquid in the case of deviation test results of 2523.1 ?g/ml, in the case of the original conditions unchanged, re-sample the standard solution and sample solution The result of 3020-E190901-T immersion application fluid was obtained, and the results of both samples were in line with SOP requirements of sOP of 6000 ?g/ml. This deviation has no effect on the quality of production assessment.<br><br>1. The error map is invalidated.<br>2. Re-evaluate the adaptability of the instrument system and then sample detection 3020-E190901-T immersion application fluid, and issue a test report.<br>3. Follow-up observation on the instruments on all network servers controlled by the microbes two central control units for three months to see if any similar situation struck.

On October 1, 2019, at 10.45, when analyst Li Rubin detected 3020-e190901-t lovastatin immersion solution, he found that when the sequence went to the back injection standard solution, the online workstation interface displayed a gray error (gray is the off-line indicator light of the instrument module), and the instrument stopped injection.<br>This deviation may be caused by the accidental interruption of network communication, resulting in the suspension of instrument sample injection.<br>1. This deviation may be caused by the accidental interruption of network communication, which has nothing to do with the product quality.<br>2. The test result of lovastatin 3020-e190901-t immersion solution was 2523.1 μ g / ml in case of deviation. When the original conditions were unchanged, the standard solution and sample solution were tested again. The result of 3020-e190901-t immersion solution was 2520.2 μ g / ml, and the results of two injections met the requirements of SOP ≤ 6000 μ g / ml. This deviation has no impact on the production quality assessment.<br>1. Cancel and retain the error map.<br>2. After reevaluation of the adaptability of the instrument system, sample 3020-e190901-t immersion solution and issue the test report.<br>3. Follow up and observe the instruments on all the network servers of the second Department of Microbiology for three months to see if there is similar situation.