基于《药品经营质量管理规范现场检查指导原则》储存与养护条款对检查缺陷项目的分析

Analysis of Inspection Defect Items Based on the Storage and Maintenance Provisions of Guidelines for On-Site Inspection of Good Supply Practice for Drugs

药品属于特殊商品,其质量安全关系公众的生命健康。药品的储存与养护是药品流通环节中质量管理的关键环节,是保障药品安全有效可及、防止药品发生质量变化的重要手段。本文从《药品经营质量管理规范现场检查指导原则》在药品的储存与养护方面的规定条款着手,结合药品现场检查工作实际,总结了药品经营企业在储存与养护环节出现的主要缺陷问题,并分析其原因,为药品监管部门科学开展市场监督检查工作和药品经营企业合理开展储存与养护工作提出建议。

Drugs are special commodities,and their quality and safety are crucial for public life and health.The storage and maintenance of drugs are the key to quality management in the process of drug distribution,and are important means to ensure the accessibility,safety,and effectiveness of drugs and prevent intrinsic quality variations of drugs.This study focuses on the provisions regarding drug storage and maintenance in the Guidelines for On-Site Inspection of Good Supply Practice for Drugs.Combining practical experience from on-site inspections,the paper summarizes the main defects encountered by drug distributors in the storage and maintenance process,analyzes their causes,and puts forward suggestions for drug market supervision and inspection,as well as rational storage and maintenance of drug distributors.