山东省无菌药品生产企业色谱系统数据可靠性现状分析

Analysis on the data integrity of chromatographic system of sterile pharmaceutical production enterprises in Shandong Province

《药品生产质量管理规范(2010年修订)》附录《计算机化系统》自2015年12月1日起施行,该附录对药品生产企业计算机化系统的数据可靠性提出了明确要求。从2015年以来的检查情况看,国内企业在数据可靠性方面还存在很多薄弱环节。本文通过对山东省无菌药品生产企业色谱系统数据可靠性现状进行调研,发现数据可靠性的薄弱环节,评估数据可靠性存在的风险,促使企业尽快提升以符合附录要求。

The annex ＂ Computerized System＂ to ＂ Good Manufacturing Practice （2010 Revision） ＂ came into effect since December 1,2015, which proposed clear request on data integrity of the computerized system.Many domestic enterpri-ses were found to be still weak in data integrity based on the inspection since 2015.Through the investigation on the data in-tegrity of chromatographic system of sterile drug production enterprises in Shandong Province, this paper aimed to find out the weaknesses of data integrity, evaluate the risks of data integrity and prompt enterprises to upgrade to meet the require-ments of the annex.