药品生产企业质量保证系统要点分析

通过对国内外药品生产质量管理规范中有关质量保证规定的梳理,从质量管理角度对质量保证系统进行分析,明确药品生产企业质量保证系统及其各要素。通过对近几年国内外药品检查中发现的药品生产企业在质量保证系统中存在缺陷的分析,对文件管理、偏差处理、变更控制、质量回顾、自检与外部检查、投诉、不良反应报告与监测、纠正与预防措施、召回、管理评审等质量保证系统各关键要素常见问题进行总结与提炼。为我国制药行业进一步加强质量保证系统的建设提供参考,同时也为药品检查工作中对质量保证系统相关要素的高效检查提供借鉴。

Analysis of Key Points in Quality Assurance System of Pharmaceutical Manufacturer

Based on the study of quality assurance requirements in the domestic and foreign Good Manufacturing Practice and the analysis of quality assurance system from quality management view,the key points and critical elements of the quality assurance system were defined.Through the analysis of observations of quality assurance system in domestic and overseas drug inspections in recent years,this paper summarizes and refines the common problems in each critical elements of quality assurance system,including document management,deviation handling,change control,quality review,self-inspection and external inspection,complaints,adverse reaction report and monitoring,corrective and preventive action,recall and management review.It provides suggestions and information for the pharmaceutical industry to further strengthen the quality assurance system,provides reference and consideration on how to inspect relevant elements of quality assurance system of pharmaceutical manufacturer efficiently.