该报告目的在于评估2D模块注射用头孢呋辛钠750mg的生产工艺过程可能存在的风险，以及应采取的控制措施以最大限度地降低药品生产过程中的污染、交叉污染以及混淆、差错等风险，确保能够持续稳定地生产符合质量要求的产品。

This report is to assess the probable risks during the manufacture process of 750mg Cefuroxime Sodium Powder for Injection in Module 2D, and also the measures we shall take to maximally reduce risks caused by contamination, cross-contamination, mix-up and error in the manufacturing process, aiming at steadily obtaining products which complies with the specifications.

范围/Scope

该风险评估报告适用于2D模块注射用头孢呋辛钠750mg（欧盟产品）的产品生产工艺。

This Risk Assessment report applys to the manufacture process of 750mg Cefuroxime Sodium Powder for Injection (for EU Market) in Module 2D.

参考文件/References

EudraLex，欧盟药品准则第4卷 -人用及兽用药品欧盟药品质量管理规范，附录1：无菌产品生产。

EudraLex, The Rules Governing Medicinal Products in the European Union Volume 4, European Union Guidelines to Good Manufacturing Practice, Medicinal Products for Human and Veterinary Use, Annex 1 Manufacture of Sterile Medicinal Products.

Q/00-MG-013质量风险管理规程Quality Risk Management

系统描述/System Description

无菌头孢呋辛钠、玻璃瓶、胶塞和铝塑盖直接采购。这些物料经过质量控制部的取样、测试后，由物料放行人批准放行使用。

The sterile API cefuroxime sodium, glass vials, rubber stoppers and Alu. flip-off caps are directly purchased. All materials are sampled, tested by quality control and released by authorized personnel for manufacturing use.

印制的标签（卷）、单独折叠的说明书、印制的纸盒和纸箱直接采购。在包装过程中，将在瓶签上打印批特有的信息。

The pre-printed roll labels, individually folded pre-printed package inserts, pre-printed cartons and pre-printed boxes for the packaging are purchased. The labels are imprinted with lot specific information during the packaging operation.

无菌原料药包装在无菌、密封的铝桶中。将无菌API桶连接到分装机上专有的接口后，即可将无菌API提供给分装机进行分装。

The sterile Cefuroxime sodium is provided in sterile, sealed aluminum containers. The Cefuroxime sodium is provided to the filling line by attaching an aluminum can of the sterile Cefuroxime sodium to the designated fitting on the filling machine.

呼吸袋装免洗胶塞经蒸汽灭菌后通过分装机胶塞振料斗输入到分装机上。

The ready-to-sterilize stoppers are sterilized and then introduced to the filling machine by a stopper vibration bowl.

西林瓶通过传送带送到洗瓶机
The vials are moved into the vial washer by a conveyor.

洗瓶机用于清洗西林瓶，共经过六个步骤。后四个清洗步骤装有喷针提升装置，以能够使喷针到达西林瓶的内部和外部，并将过滤后的循环注射用水、过滤后的压缩空气或过滤后的新鲜注射用水集中有效地喷淋到所需清洗的部位。

The Vial Washer is used to wash glass vials. Six washing steps shall be undergone; the last four step incorporates needle-lifting units where the needles reach inside and outside the vials in order to deliver a concentrated spray of filtered recycled WFI, filtered compressed air or fresh filtered WFI.

清洗工艺结束后，还未全部干燥的西林瓶自动地经过卸载区传送至隧道烘箱。隧道烘箱通过干热法对清洗过的西林瓶进行灭菌及去热原。西林瓶自动地进入灭菌隧道后，将经过如下三个工艺区：
At the end of the cycle, the partially dried vials are delivered individually to an unloading tray for onward transfer to the sterilizing tunnel.The Sterilizing Tunnel is used to sterilize and depyrogenate washed vials by exposing them to dry heat. Vials are automatically loaded into the tunnel before being passed through 3 processing zon