从药品检查角度分析与研究制药企业文件管理的常见问题及改进措施

The Common Problems and Improvement Measures of Document Management in Pharmaceutical Enterprises Were Analyzed and Studied From the Perspective of Drug Inspection

药品生产企业文件管理是决定“上层建筑”的“基础”,对于保证产品质量、确保合规性以及满足药品监管要求至关重要。本文从药品检查的角度出发,对药品生产企业文件管理中的常见问题进行了分析,并提出了相应的改进措施,包括深入贯彻全员质量意识、真正建立良好的文件体系、运用现代化电子信息手段等。本文希望能够为制药企业改进文件管理提供参考。

The file management of pharmaceutical manufacturing enterprises is the“foundation”that determines the“superstructure”,and it is crucial for ensuring product quality,ensuring compliance,and meeting pharmaceutical regulatory requirements.This article analyzes common problems in file management of pharmaceutical manufacturing enterprises from the perspective of pharmaceutical inspection and proposes corresponding improvement measures,including deeply implementing a comprehensive quality consciousness among all staff,truly establishing a good file system,and utilizing modern electronic information technology.This article hopes to provide reference for improving file management in pharmaceutical enterprises.