关键词: font-size:medium, ">除菌过滤；无菌药品；缺陷项；生产质量管理

Abstract: Liquids sterilizing filtration is one of the key technologies in the production of sterile medicinal products. This study analyzed the GMP requirement and guidelines about systerm filtration， and combined with the actual situation of the industry， specified the key points of inspection in filter selection and validation， filter system design， sterilization filtration verification， integrity testing， sterilization and use of filtration systern. Based on a statistical analysis on the defect items of liquids sterilizing filtration observed in domestic and foreign regulatory inspections in recent years， the distribution of observed defect items and common problems were identified. Through the study， it provides suggestions and reference for the pharmaceutical industry to further improve the implementation of liquids sterilizing filtration， and provides reference on regulatory inspection to liquids sterilizing filtration.

Key words: font-size:medium, ">Sterilizing filtration； Sterile medicinal products； Defect item； Production quality management