2021年01月20日10时25分，分析员陈萍在Y66幢二楼实验室编号

At 10:25 on January 20, 2021, analyst Chen Ping processed the 3046011N210105-01 batch of ticagrelor alkylation reaction solution sample map on the second floor laboratory of Y66 building No. A-CAY-Y66-11. At the time, it was found that the main peak area (198474) was too small, much lower than the historical detection level, and the main peak area of ​​the historical detection batch (such as 3046011N210104-01) was 7751890. <br><br><br>The root cause of this deviation is that the employees used the sampler for sampling for the first time, and they did not practice for a long time after training. When sampling, the material liquid pressed into the sampler for the first time was not collected into the beaker, but the material liquid was directly used as the target sample. Sampling results in getting a sample of the diluted reaction solution, and the deviation is caused by personnel. <br><br>After the 3046011N210105-01 batch of ticagrelor alkylation reaction solution was re-sampled and tested, the test results met the requirements, and the main peak area was consistent with the historical batch trend, and there was no risk. Looking back at the historical production batches, no similar deviation event occurred, which has no impact on the quality of the historical batches. In order to prevent similar incidents from occurring in the future, relevant personnel were re-trained in H3-SOP-61042 "Intermediate Sampling Operating Procedures", emphasizing that the material that needs to be pressed into the sampler for the first time before sampling the ticagrelor alkylation reaction liquid Liquid collection and processing. <br><br><br>CP-TZ-API-D-TZ-API-IP-21005-21001: 3046011N210105-01 batch of ticagrelor alkylation reaction solution to re-sampling and testing. <br>CP-TZ-API-D-TZ-API-IP-21005-21002: Re-train related personnel in H3-SOP-61042 "Intermediate Sampling Procedures", emphasizing the sampling of ticagrelor alkylation reaction solution The material liquid pressed into the sampler for the first time needs to be collected and processed.

At 10:25 on January 20, 2021, when analyst Chen Ping processed the sample chromatogram of 3046011n210105-01 batch of ticagrelor alkylation reaction solution on the laboratory No. a-cay-y66-11 on the second floor of building y66, she found that the main peak area (198474) was too small, far lower than the historical detection level, and the main peak area of historical detection batch (such as 3046011n210104-01) was 7751890.<br>The root cause of the deviation was that the staff used the sampler for the first time for sampling operation and did not practice it for a long time after training. During sampling, they did not collect the material liquid pressed into the sampler for the first time to the beaker, but directly took the material liquid as the target sample for sampling, resulting in the diluted reaction liquid sample. The deviation was caused by the staff.<br>3046011n210105-01 batch of tegrilol alkylation reaction solution was re sampled and tested, and the test results met the requirements. At the same time, the main peak area was consistent with the trend of historical batches, and there was no risk. Reviewing the historical production batches, no similar deviation events occurred, which had no impact on the quality of historical batches. In order to prevent similar incidents in the future, the relevant personnel were retrained in h3-sop-61042 "intermediate sampling operation procedures", emphasizing that the feed liquid first pressed into the sampler should be collected and treated before sampling the tegrilol alkylation reaction liquid.<br>Cp-tz-api-d-tz-api-ip-21005-21001:3046011n210105-01 batch of ticagrelor alkylation reaction solution for resampling and detection.<br>Cp-tz-api-d-tz-api-ip-21005-21002: retraining h3-sop-61042 "intermediate sampling operation procedure" for relevant personnel, emphasizing the need to collect and treat the feed liquid that is first pressed into the sampler before sampling tegrilol alkylation reaction liquid.<br>

At 10: 25 on January 20, 2021, analyst Chen Ping processed the 3046011N210105-01 batch of samples of tigrel alkylation reaction solution on the second floor laboratoryNo. A-CAY-Y66-11 of Building Y66, and found that the main peak area (198474) was small, far lower than the historical detection level, and the historical detection batch (such as 304600The root cause of this deviation is that the staff used the sampler for sampling operation for the first time, but did not practice it for a long time after training. During sampling, the feed liquid pressed into the sampler for the first time was not collected into the beaker, but was directly sampled as the target sample, which led to the diluted reaction liquid sample, resulting in deviation, which was due to personnel reasons.After re-sampling and testing of the Tigrinol alkylation reaction solution in 3046011N210105-01, the test results meet the requirements, and the peak area of the main peak is consistent with the historical batch trend, without risk. Looking back at the historical production batches, no similar deviation events occurred, which had no impact on the product quality of the historical batches. In order to prevent similar incidents from happening in the future, relevant personnel were retrained in H3-SOP-61042 "Intermediate Sampling Operation Procedures", emphasizing that the feed liquid pressed into the sampler for the first time should be collected and processed before sampling the reaction liquid of Tigrinol alkylation.CP-TZ-API-D-TZ-API-IP-21005-21001: 3046011N210105-01 batch of tigrel alkylation reaction solution was re-sampled for detection.CP-TZ-API-D-TZ-API-IP-21005-21002: Re-train relevant personnel in H3-SOP-61042 Intermediate Sampling Operation Procedures, emphasizing the need to collect and treat the feed liquid pressed into the sampler for the first time before sampling the tigrillo alkylation reaction liquid.