10:05，金松在检查114房间的中间体储存情况时，发现盐酸表柔比星粗

10:05, Jinsong intermediate storage conditions in the inspection room 114, found in Table doxorubicin hydrochloride crude product packaging labels displayed on the manufacturing date 2019.03.11, valid for 2021.03.11; doxorubicin hydrochloride current table is valid for crude 2, according to the H0-SOP-71025 Drug predetermined lifetime management procedures, the effective date of production date = + -1 day period, the batch of crude material thus shall be valid 2021.03.10. <br><br>Ren Lijun work because the staff is not careful, in the calculation of the effective date, the date of manufacture plus the expiration date, forget minus one day. <br><br>When deviations occur batch of crude has not been using the current label has been replaced, while viewing the other batches of materials and other intermediate label, the label information is correct, and no similar mistakes. The deviation no adverse effects on the quality of the batch. <br><br><br>1. The replacement of the table immediately doxorubicin hydrochloride crude batches of an outer label 1060-190302. <br>2. Training H0-SOP-71025 Drug Administration regulations valid for the workshop materials management procedures H3-SOP-61035 relevant personnel, emphasized fill intermediate labels carefully to ensure accurate label information.

10:05，金松在检查114房间的中间体储存情况时，发现盐酸表柔比星粗品外包装标签显示的生产日期为2019.03.11，有效期为2021.03.11；目前盐酸表柔比星粗品有效期为2年，根据H0-SOP-71025药品效期管理规程规定，有效日期=生产日期+有效期-1天，因此该批粗品有效期应为2021.03.10。 <br><br>由于人员任丽君工作不仔细，在计算有效日期时，将生产日期加上有效期，忘记再减去1天。 <br><br>偏差发生时该批粗品尚未进行使用，目前标签已经更换，同时查看其它批次以及其他中间体的物料标签，标签信息均准确无误，未发现类似错误。本次偏差对该批产品质量无不良影响。 <br><br><br>1.立即对盐酸表柔比星粗品1060-190302批次的外包装标签进行更换。<br>2.对相关人员进行H0-SOP-71025药品效期管理规程与H3-SOP-61035车间物料管理规程的培训，强调填写中间体标签时，要认真仔细，确保标签信息准确。

10: 05. When Jinsong inspected the storage of intermediates in room 114, it was found that the production date indicated on the outer packing label of crude epirubicin hydrochloride was 2019.03.11, with an expiry date of 2021.03.11; at present, the expiry date of crude epirubicin hydrochloride is 2 years, according to h0-sop-71025 drug expiry management procedure, with an expiry date = production date + expiry date - 1 day, so the expiry date of this batch of crude products should be 2021 .03.10.<br>Due to Ren Lijun's careless work, when calculating the effective date, add the production date to the effective period and forget to subtract another day.<br>At the time of deviation, the batch of rough products had not been used. At present, the label has been replaced. At the same time, check the material labels of other batches and other intermediates. The label information is accurate, and no similar error was found. This deviation has no adverse effect on the quality of this batch of products.<br>1. Immediately replace the outer package label of batch 1060-190302 of epirubicin hydrochloride.<br>2. Train relevant personnel on h0-sop-71025 drug validity management procedure and h3-sop-61035 workshop material management procedure, and emphasize that when filling in the intermediate label, it is necessary to be careful to ensure that the label information is accurate.<br>