对我国制药企业在持续工艺确认过程中存在问题的探讨

Discussion on the Problems Existing in Pharmaceuticals Continous Process Verification

持续工艺确认是药品生命周期中商业化生产阶段一项很重要的工作,做好持续工艺确认工作,能够确保药品质量持续稳定,保障人民用药安全。本文通过对国内制药企业在进行药品持续工艺确认过程中存在的主要问题进行研究和分析,并针对问题提出解决的方法和建议,以期为国内制药企业进行药品持续工艺确认工作提供有益参考。

Continuous process verification(CPV)is a very important work in pharmaceutical product lifecycle.A good job of CPV can ensure the stable and reliable quality of drugs and ensure the safety of drug use.Through investigate and analyze the main problems existing in the CPV of pharmaceutical product in domestic pharmaceutical enterprises,and to give solutions and suggestions to the problems,so as to provide useful reference for domestic pharmaceutical enterprises to carry out CPV for pharmaceutical product.