[关键词]
[摘要]
在药品生产企业的质量管理中,产品质量回顾涉及质量控制、质量保证和质量改进。部分药品生产企业未能有效开展产品质量回顾,导致在药品异常质量趋势识别、药品质量的持续改进和质量管理水平的不断提升方面存在不足。通过对国内外关于药品质量回顾的法规进行梳理,明确了有效开展药品质量回顾的要点:程序文件规定、回顾频次、回顾内容、统计分析方法、回顾问题的识别与分析、回顾结论、质量回顾报告的审核与管理,并对产品质量回顾检查中常见问题进行了分析。
[Key word]
[Abstract]
In the quality management of pharmaceutical manufacturing companies, product quality review involves quality control, quality assurance, and quality improvement. Some drug manufacturers fail to carry out product quality review effectively, which leads to deficiencies in the identification of abnormal drug quality trends, continuous improvement of drug quality, and continuous improvement of quality management level. By sorting out the domestic and foreign laws and regulations on drug quality review, this paper clarifies the main points of effectively carrying out drug quality review:procedure document regulations, review frequency, review content, statistical analysis methods, identification and analysis of review problems, review conclusions, and quality review and management of reports, and analyze common problems in product quality review inspections.
[中图分类号]
R951
[基金项目]