冻干粉针剂无菌工艺模拟灌装验证中的注意事项

Notes of the Verification of Freeze-dried Powder Injection Aseptic Process Simulation Filling

冻干粉针剂是一种制作较为复杂的药物类型,其生产主要采用无菌灌装,根据《药品生产质量管理规范(2010年修订)》及其附录要求,应开展培养基模拟灌装试验,综合评估无菌工艺过程、无菌保证水平,证明无菌灌装方法和规程的有效性,确认最差条件生产下无菌工艺生产水平是否符合要求。无菌灌封工艺的充分验证是GMP(药品生产质量管理规范)管理的重要内容。

The freeze-dried powder injection is a relatively complex type of medicine with aseptic filling of production.According to the requirements of the"Drug Production Management Regulations(the 2010 Revision)"and its appendices,medium simulation filling should be carried out.Aseptic process and aseptic assurance level should be comprehensively evaluated in the test,to prove the effectiveness of the methods and procedures used in the aseptic filling process,and to confirm whether the aseptic process production level meets the requirements under the worst conditions.Full verification of the aseptic potting process is an important part of GMP(good manufacturing practices)management.