华北制药2D模块注射用头孢呋辛钠生产工艺风险评估报告（DOC 42页）.docVIP

目的/Purpose 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 p