留样管理为药品生产质量管理体系中的一项基础性、强制性的活动，但在实际药品生产质量管理中，留样管理仍存在诸多薄弱环节和不足。梳理了法规标准中关于留样的要求和要点解析，对药品GMP检查中发现的留样相关缺陷的统计分析，将其归纳为留样数量不足或代表性不全、留样储存条件和监控不足、留样记录管理不当、留样包装与标识管理不符以及其他常见缺陷5个方面的典型问题，以期为行业提供持续改进的思路和参考，也为检查中提高留样管理方面的针对性内容提供借鉴。

Drug sample retention management is a fundamental and mandatory activity within the pharmaceutical production quality management system. However, in practical drug production quality management, there remain numerous weak links and deficiencies in drug sample retention. This article reviews the requirements and key points for drug sample retention as stipulated in regulatory standards, conducts statistical analysis of sample-related deficiencies identified during GMP inspections, and categorizes them into five typical issues: insufficient sample quantity or incomplete representativeness, inadequate storage conditions and monitoring, improper sample record management, non-compliance with sample packaging and labeling requirements, and other common deficiencies. The aim is to provide industry insights for continuous improvement and to offer references for enhancing the specificity of sample retention management in inspections.