关键词: font-size:medium, ">验证与确认；生产工艺；工艺确认；工艺验证

Abstract: Based on the study of domestic and foreign rules and guidelines about drug process validation， the basic principles and requirements of process validation were defined. Though the analysis of observations of process validation in domestic and overseas drug inspections in recent years， it summarizes and refines the common problems in process validation. It provides suggestions and reference for the pharmaceutical industry to further improve the process validation， and provides reference on inspection on process validation efficiently.
     [Key Words]Validation and Qualification； Production Process； Process Qualification； Process Validation

Key words: font-size:medium, ">Validation and Qualification； Production Process； Process Qualification； Process Validation