原料药生产企业的数据完整性管理探讨

Discussion of Data Integrity Management for API Manufacturer

旨在全面系统地阐述“数据完整性”的概念、国内外GMP对数据完整性的要求,通过分析药品生产企业在数据完整性管理上的现状,探讨需要重点关注的方面,帮助企业理清管理上的缺陷、认识上的偏差、执行上的误区,为企业解决数据完整性管理中的实际问题提供参考和借鉴。

In this article,the concept of data integrity was expounded systematically.Data integrity has been requested in Chinese and foreign GMP.With the analysis of the current situation of data integrity management in pharmaceutical enterprises,the issues needed to pay attention emphatically were discussed so as to help enterprises recognize the defects in management and the deviations in execution.With what mentioned herein,the methods for solving practical problems in data integrity management can be referenced.