2019.12.06日上午09点14分,103车间精制人员罗虎在对10

At 09:14 on the morning of December 12, 2019, Luo Hu, the refiner of Workshop 103, when reviewing the inspection report from the batch of 1018-B191201A, found that the sample name on the inspection report was bleomycin sulfate A2. The batch number is: 1018-B191201B. According to the naming rules, the batch number is inconsistent with the sample name. <br><br>When sampling person Ni Binen filled out the sampling information of the test report, he accidentally overwritten the A after the batch number of 1018-B191201A as B, and did not check the sampling information after sampling, and did not find the error in time, resulting in the deviation occur. Belong to personnel reasons. <br><br>The deviation is only due to a momentary negligence of the sampling personnel when filling in the sampling information in the test report, and the A after the batch number of 1018-B191201 was incorrectly written as B, and the sampling information was not checked again after sampling, and the Errors cause deviations. It has been confirmed that the batch of feed liquid is a bleomycin sulfate A2 component, and the test results meet the quality standards, so the risk of product quality impact is small. Because the current batch records do not require the relevant information to be checked after sampling, the relevant batch records need to be revised in order to reduce the risk. <br><br>1. The sampling personnel and the testing personnel correct the single batch number of the test report for the preparation of the mixed solution of bleomycin sulfate A2 (batch number: 1018-B191201B) to 1018-B191201A. And link the deviation number. <br>2. The tester's remarks on the preparation of the mixed solution of bleomycin sulfate A2 (batch number: 1018-B191201B): the batch number was changed to 1018-B191201A. And link the deviation number. <br>4. Train the refining personnel with the H3-SOP-71010 batch number management program version 08, emphasizing the naming rules for bleomycin batch numbers. <br>5. For H3-MPD-10134-R37-R39 bleomycin sulfate A2 or B2 preparation post batch production records, add information after sampling to confirm. <br>6. For H3-MPD-10183-R01-R03 bleomycin A2 or B2 preparation post batch production records, increase the information after sampling to confirm.

2019.12.06 a.m. 09:14 a.m., 103 workshop refining personnel Luohu in the 1018-B191201A batch record of the inspection report sheet, found that the test report list on the sample name is sulphate bolemymycin A2 preparation mixture, batch number: 1018-B191201B. According to naming rules, lot numbers do not match the sample name. <br><br>Because the sampling officer Yu Binn in filling out the sampling information of the test report sheet, due to a momentary negligence of 1018-B191201A batch number after the A mischaracterized as B, and after sampling did not check the sampling information, did not find the error in time, resulting in the deviation occurred. It's for personnel reasons. <br><br>This deviation is only due to the sampling personnel in filling out the sampling information in the test report form due to a momentary negligence, the 1018-B191201 batch number after the A mischaracterized as B, and after sampling did not check the sampling information, the error was not found in time to cause the deviation occurred. It was confirmed that the batch liquid was a component of bolemymycin a sulfate, and the test results met the quality standards, so the risk of impact on product quality was small. As the current batch record, there is no provision for sampling after the relevant information to check, so the follow-up need to revise the relevant batch records to reduce the occurrence of this risk. <br><br>1. The single batch number of the inspection report for the preparation of the bolemycin A2 preparation mixture (lot number: 1018-B191201B) by the sampler and the inspector was corrected to 1018-B191201A. and link the deviation number.<br>2. The test personnel on the sulphate bolemycin A2 preparation mixture (lot number: 1018-B191201B) map note: batch number modified to 1018-B191201A. and link the deviation number.<br>4. Training of the refined personnel in the H3-SOP-71010 batch number management procedure 08, emphasizing the naming rules of the Bolamycin lot number.<br>5. For H3-MPD-10134-R37-R39 sulphate bolemycin A2 or B2 preparation post batch production record, increase sampling information confirmation.<br>6. For H3-MPD-10183-R01-R03 acid bolemycin A2 or B2 preparation post batch production record, increase sampling information confirmation.

At 09:14 a.m. on December 6, 2019, Luo Hu, the refining personnel of workshop 103, was reviewing the inspection report form recorded in batch 1018-b191201a, and found that the sample name on the inspection report form was bleomycin sulfate A2 preparation mixture, and the batch number was 1018-b191201b. According to the naming rules, the batch number is inconsistent with the sample name.<br>When Ni bin'en, the sampling personnel, filled in the sampling information of the test report, mistakenly wrote a after the batch number of 1018-b191201a as B. at the same time, he did not check the sampling information again after sampling, and did not find the error in time, resulting in the deviation. Due to personnel reasons.<br>This deviation is only caused by the sampling personnel's negligence in filling in the sampling information in the test report, writing a wrong in the back of Lot No. 1018-b191201 as B, and failing to check the sampling information after sampling, and failing to find the error in time, which leads to the deviation. It is confirmed that the batch of feed solution is bleomycin sulfate A2 component, and the test results meet the quality standard requirements, so the risk of product quality impact is small. As there is no provision in the current batch record that the relevant information needs to be checked after sampling, the subsequent revision of the relevant batch record is required to reduce the risk.<br>1. The batch number of the test report of bleomycin sulfate A2 mixed solution (batch number: 1018-b191201b) prepared by the sampling personnel and the testing personnel was corrected to 1018-b191201a. And link the deviation number.<br>2. The tester's remarks on the atlas of bleomycin sulfate A2 preparation mixture (batch number: 1018-b191201b): the batch number is modified to 1018-b191201a. And link the deviation number.<br>4. train the refining personnel on the batch management procedure of H3-SOP-71010 (version 08), and emphasize the naming rules of bleomycin batch number.<br>5. For batch production record of h3-mpd-10134-r37-r39 bleomycin sulfate A2 or B2 preparation post, add information confirmation after sampling.<br>6. for batch production record of preparation post of H3-MPD-10183-R01-R03 acid bleomycin A2 or B2, increase information confirmation after sampling.