2019年9月5日下午16:00左右，车间操作人员胡云程从IPC领回1

At about 16:00 on September 5, 2019, workshop operator Hu Yuncheng received 1100-B190901 batches of idarubicin hydrochloride intermediates ⑥ filter cake and idarubicin hydrochloride intermediates ⑥ inspection report form from IPC. The batch numbers on the two inspection reports are 1100-B190803, which is inconsistent with the batch number 1100-B190901 on the batch production records. <br><br>The direct cause of the deviation is that the operator mistakenly wrote the batch number wrongly, and the fundamental reason is that the operator referred to the incorrect document when writing the batch number. <br><br>This deviation involves the batch number information of the 1100-B190901 batch of idarubicin hydrochloride intermediate ⑥ filter cake and the idarubicin hydrochloride intermediate ⑥, the sample itself was not wrong, nor was it sent wrong. Quality itself will not affect, but it will cause a series of inconsistent information in GMP documents. <br><br>1. Specification modification 1100-B190901 batch of idarubicin hydrochloride intermediate ⑥ filter cake and idarubicin hydrochloride intermediate ⑥ sample inspection report, sample label, IPC sample receiving account book, original test record and other batch numbers on GMP documents information. And link the deviation number at the modification. <br>2. Revise the batch production records of idarubicin hydrochloride intermediate ⑤ and intermediate ⑥, and add a review of the inspection report to the batch production records involving intermediate sampling positions. Trained idarubicin hydrochloride operators on the revised batch records, and emphasized that when filling in the intermediate inspection report, a review is required, and the batch number and other information must be based on the batch records.

2019年9月5日下午16:00左右，车间操作人员胡云程从IPC领回1100-B190901批盐酸伊达比星中间体⑥滤饼与盐酸伊达比星中间体⑥检验报告单时，发现这两张检验报告单上的批号均为1100-B190803，与批生产记录上的批号1100-B190901不一致。 <br><br>偏差发生的直接原因是操作人员误将批号写错，根本原因是操作人员书写批号时参考的文件不正确。 <br><br>本次偏差涉及1100-B190901批盐酸伊达比星中间体⑥滤饼与盐酸伊达比星中间体⑥的批号信息错误，样品本身没有取错、也未送错，批号信息的错误对中间体质量本身不会产生影响，但会造成一系列GMP文件信息不一致的问题。<br><br>1.规范修改1100-B190901批盐酸伊达比星中间体⑥滤饼及盐酸伊达比星中间体⑥样品检验报告单、样品标签、IPC样品接收台账、原始检测记录等GMP文件上的批号信息。并在修改处链接偏差号。<br>2.对盐酸伊达比星中间体⑤和中间体⑥批生产记录进行修订，在涉及中间体取样岗位的批生产记录中增加对检验报告单复核。对盐酸伊达比星操作人员针对修改后的批记录进行培训，并强调在填写中间体检验报告单时，需要进行复核，批号等信息必须以批记录为标准。

At about 16:00 p.m. on September 5, 2019, when Hu Yuncheng, the workshop operator, took back 1100-b190901 batches of inspection report sheets for IDA intermediate ⑥ filter cake and Ida intermediate ⑥, it was found that the batch numbers on the two inspection report sheets were 1100-b190803, which were inconsistent with the batch numbers 1100-b190901 on the batch production record.<br>The direct cause of the deviation is that the operator mistakenly wrote the batch number, and the root cause is that the document referred to by the operator when writing the batch number is not correct.<br>This deviation involves the batch number information error of 1100-b190901 batch of intermediate ⑥ filter cake and intermediate ⑥ of IDA bicin hydrochloride. The sample itself has not been taken wrongly or sent wrongly. The batch number information error will not affect the quality of the intermediate itself, but will cause a series of problems of inconsistent GMP document information.<br>1. Modify the batch number information on GMP documents such as 1100-b190901 batch of IDA bicin hydrochloride intermediate ⑥ filter cake and Ida bicin hydrochloride intermediate ⑥ sample inspection report, sample label, IPC sample receiving account, original test record, etc. And link the deviation number where it is modified.<br>2. Revise the batch production records of the intermediate ⑤ and the intermediate ⑥ of IDA bicin hydrochloride, and add the review of the inspection report in the batch production records involving the intermediate sampling post. Train the operators of edapisin hydrochloride on the modified batch record, and emphasize that when filling in the intermediate inspection report form, it is necessary to recheck, and batch number and other information must be based on the batch record as the standard.