USP 43-NF38<1211>无菌保障

USP 43-NF38<1211>sterility assurance

无菌是无菌药品的关键质量属性。无菌药品的生产必须严格按照精心设计并经验证的方法及规程进行,药品的无菌绝不能只依赖于任何形式的最终处理或成品检验。USP在2019年修订了通则<1211>无菌保障,将无菌药品的生产工艺分为最终灭菌、无菌生产工艺、最终灭菌结合无菌生产工艺三类,全面阐述了影响无菌保障的各个要素。现将USP 43-NF38该章节译出,以期为无菌药品生产及新版药典增订相关内容提供参考。

Sterility is one of critical quality attributes of sterile drugs.This type of manufacture must strictly follow carefully established and validated methods and procedures.Sterility can not solely rely on any terminal process or finished product test.The general chapter<1211>Sterility Assurance of the United States Pharmacopeia was revised in 2019.In the revision,the processes of sterile drugs are divided to three types,including aseptic processing,terminal sterilization and post-aseptic processing terminal sterilization,and the elements contributing to sterility assurance are described.The chapter is translated into Chinese in order to provide reference for the manufacture of sterile drugs and relevant content for revision of the Chinese pharmacopoeia.