2019年09月17日，工艺员王磊在阿糖胞苷生产线称量区检查记录时，发

On September 17, 2019, when technician Lei checked the weighing records in the weighing area of ​​the cytarabine production line, he discovered that operator Zheng Shuru weighed the arabins for the first time using the AWH-1507W electronic scale at 12:50 on September 15, 2019. Glycoside 1036-A190808 batch of crude products, and the daily calibration record of this electronic scale does not have the record of its calibration before use. <br><br>The reason for this deviation is that the operator Zheng Shuru and the reviewer Hu Guorong did not perform the first verification of the electronic scale before production as required in the production, resulting in the occurrence of this deviation. <br><br>1. The AWH-1507W electronic scale was properly calibrated and cleaned on September 14, 2019, and no adjustments were made until this deviation occurred. Before weighing and using on September 15, 2019, confirm whether there is any interference on the symmetrical measuring platform, whether it is clean and dry, whether the horizontal bubble is centered or placed stably, and whether it is cleared, etc., all meet the requirements. 2. The weight of crude cytarabine 1036-A190808 batch is 27.10 kg. On September 17, 2019, the AWH-1507W electronic scale was re-calibrated according to the daily calibration, use and maintenance procedures of the electronic scale. The crude cytarabine 1036-A190808 batch was re-weighed and weighed using the same specifications of packaging materials. Heavy tare, the true net weight of 1036-A190808 batch of crude products is obtained within the allowable range of error. Therefore, the weight of the crude batch of cytarabine 1036-A190808 is consistent with the record before uncalibration. 3. Therefore, the unadjusted electronic scale does not affect the net weight of the crude products in this batch, nor does it affect the product quality and yield. 4. The batch of crude cytarabine 1036-A190808 has been re-weighed as required on 2019.09.17, and is consistent with the previous weight, so it has no impact on the subsequent production, and the intermediate production can be carried out after the intermediate test is qualified. <br><br>1. Train relevant personnel on H0-TM-23101 "Daily Calibration, Use and Maintenance Procedures of Electronic Scales", emphasizing that electronic scales and electronic scales are equal, and daily calibration should be carried out before each day of use. The reviewer should handle all operations and records of the operator Confirm the content.

On September 17, 2019, when the craftsman Wang Lei checked the records in the weighing area of the aglyglyphicacid production line, he found that the operator, Zheng Shuru, had used the AWH-1507W electronic scale for the first time on September 15, 2019, to weigh the batch of aglycoside 1036-A190808 batch of calibration, which was not calibrated in the daily calibration records of the electronic scale. <br><br>The reason for this deviation is that operator Zheng Shuru and reviewer Hu Guorong did not perform the first check of the electronic scale before production as required in production, resulting in the occurrence of this deviation. <br><br>1.AWH-1507W scales were properly corrected and cleaned on September 14, 2019, and no adjustments were made until this deviation occurred. Before the use of the weigh-in on September 15, 2019, whether there is any object interference on the symmetrical scale, whether clean and dry, whether the horizontal bubble is centered or placed smoothly, whether to clear zero, etc. to confirm, all meet the requirements. 2. The weight of the batch of aglycine 1036-A190808 batch is 27.10 kg. On September 17, 2019, the AWH-1507W electronic scale was re-corrected in accordance with the daily correction, use and maintenance procedures of the electronic scale, reweighed the batch of aglycine 1036-A190808 batch, weighed with the same specification package, and obtained 1036-A190808 batch of crude mass net heavy weight within the marginofs. Therefore, the weight of the batch of aglycine 1036-A190808 batch is consistent with the uncorrected pre-record. 3. Therefore, this electronic claim uncorrected does not affect the net weight of this batch of crude products, does not affect product quality and yield. 4. A glycoside 1036-A190808 batch of crude products has been re-weighed as required on 2019.09.17, and consistent with the previous weight, so there is no impact on subsequent production, intermediates test ingress can be carried out after the next production.<br><br>1. The relevant personnel to H0-TM-23101 "electronic scale daily correction, use and maintenance procedures" training, emphasizing the e-scale and electronic day equality, daily use should be carried out before daily correction, the reviewer should be the operator of all operations and records to confirm.

On September 17, 2019, when Wang Lei, a technologist, inspected the records in the weighing area of the cytarabine production line, he found that Zheng Shuru, the operator, first weighed the 1036-a190808 batches of crude cytarabine with awh-1507w electronic scale at 12:50 on September 15, 2019, and there was no record of correction before use in the daily calibration record of the electronic scale.<br>The reason for this deviation is that Zheng Shuru, the operator, and Hu Guorong, the reviewer, failed to conduct the first calibration of the electronic scale before production as required, which led to this deviation.<br>1. Awh-1507w electronic scale has been calibrated and cleaned normally on September 14, 2019, and no adjustment has been made until this deviation occurs. Before weighing and using on September 15, 2019, confirm whether there is any object interference, whether it is clean and dry, whether the horizontal bubble is centered or placed stably, whether it is cleared, etc., all of which meet the requirements. 2. The weight of batch 1036-a190808 of cytarabine was 27.10kg. On September 17, 2019, awh-1507w electronic scale was re calibrated in accordance with the daily calibration, use and maintenance procedures of electronic scale, and the batch of crude arabinoside 1036-a190808 was re weighed, and the same specification of packaging material was used to weigh and peel, and the actual net weight of 1036-a190808 batch of crude products was obtained within the allowable range of error. Therefore, the weight of batch 1036-a190808 of cytarabine was the same as that recorded before correction. 3. Therefore, the uncorrected electronic scale does not affect the net weight of this batch of crude products, product quality and yield. 4. The batch of arabinoside 1036-a190808 has been reweighed as required on September 17, 2019, and the weight is the same as the previous batch, so it has no impact on the subsequent production, and the next production can be carried out after the intermediate is qualified.<br>1. Train relevant personnel on h0-tm-23101 daily calibration, use and maintenance procedure of electronic scale, emphasize the electronic scale and electronic balance, conduct daily calibration before daily use, and the reviewer shall confirm all operations and records of the operator.<br>