1. 根据VC-ROSU-1701瑞舒伐他汀钙原料药工艺和设备变更通知

1. According to VC-ROSU-1701 rosuvastatin calcium API technology and equipment change notification, apply for this change, and to assess the impact of pharmaceutical raw materials for the formulation of product quality after the change. <br>2. Formulation Division 307 workshop planned 2019 increase in production capacity, the existing P2020 tablet machine production line can not meet production needs, the need to start the P3030 tablet press, rosuvastatin 5mg new line of plastic packaging, production tasks; Ruishu atorvastatin calcium 5mg & 10mg longer drying time granulation step is necessary to increase the amount of intake air damper, the drying process stacker operation, shorten the drying time, increase production efficiency. <br>"

1. 根据VC-ROSU-1701瑞舒伐他汀钙原料药工艺和设备变更通知，申请此变更，并评估变更后原料药对制剂产品质量的影响。<br>2. 制剂事业部307车间2019年计划产能增加，现有P2020压片机生产线无法满足生产需求，需启动P3030压片机，新增瑞舒伐5mg铝塑包装线，投入生产完成任务；瑞舒伐他汀钙片5mg&10mg制粒工序干燥时间较长，需要提高进风风量，烘干过程进行翻料操作，缩短干燥时间，提高生产效率。<br>"

1. According to vc-rosu-1701 change notice of process and equipment of rosuvastatin calcium API, apply for the change, and evaluate the impact of the changed API on the product quality.<br>Two The production capacity of 307 workshop of preparation business department is planned to increase in 2019. The existing p2020 tablet pressing machine production line cannot meet the production demand. P3030 tablet pressing machine needs to be started, and a new 5 mg aluminum plastic packaging line needs to be added, which is put into production to complete the task. The drying time of 5 mg-10 mg granulating process of rosuvastatin calcium tablet is relatively long, which needs to increase the air intake volume, turn over the material during the drying process, shorten the drying time, and improve the production Production efficiency.<br>"