摘要
包装系统密封性,又称容器密封完整性,是指药品的包装系统防止微生物侵入以及维持药品各项质量指标持续符合安全和质量要求的能力。包装系统密封性的研究始于产品的开发阶段,并持续贯穿产品生命周期,是无菌药品生产、质量研究和评价的一项重点关注内容。本文参考《美国药典》〈1207〉系列指导原则,从审评角度对无菌药品包装系统密封性的概念和范围、不同产品生命周期阶段的密封性要求、检测方法和验证等相关内容进行介绍和探讨,以期为国内无菌药品的质量研究和评价工作提供有益参考。
Package integrity,which is synonymous with container-closure integrity,is the ability of a package to maintain product quality,including preventing microorganism ingress and ensuring that the product meets all necessary safety and quality requirement.Package integrity assessment begins at the product development phase and continues throughout the product life cycle,which is a key consideration in the manufacturing,quality research and evaluation of sterile products.This article mainly refers to the US Pharmacopeia(USP)〈1207〉guidelines,based on the understanding of CMC review experience,introduces and discusses the content of container-closure integrity,including concepts and scope,the requirements of different product life cycles,testing methods and validation,etc.It is hoped that the content of this article will provide some references for the quality study and evaluation of sterile pharmaceutical products.
作者
郭涤亮
董武军
马骏威
王璐
李中杰
GUO Di-liang;DONG Wu-jun;MA Jun-wei;WANG Lu;LI Zhong-jie(Center for Drug Evaluation,National Medical Products Administration,Beijing 100022,China)
出处
《中国新药杂志》
CAS
CSCD
北大核心
2021年第10期880-885,共6页
Chinese Journal of New Drugs
