我国现行版的GMP融合了欧盟和WHO新版的GMP中的生命周期概念,本文就生命周期的三个阶段的工艺验证进行概述。目的:验证药品的生命周期。方法:工艺验证,工艺设计。结果:工艺验证是动态的和持续管理的过程,对于药品生产来说是一个法定的、强制性的要求。结论:要重视工艺验证在实际生产中的作用。把工艺验证贯穿于药品生产的全过程中。 The current version of GMP in our country integrates the concept of life cycle in the new GMP version of the EU and the WHO. This article provides an overview of the process validation in the three stages of the life cycle. Purpose: To verify the life cycle of medicines. Methods: Process Verification, Process Design. Results: Process validation is a dynamic and ongoing management process that is a statutory and mandatory requirement for pharmaceutical production. Conclusion: Emphasis should be placed on the role of process validation in actual production. Process validation runs through the entire process of drug production.