药品色谱检测中的数据完整性问题探讨

Discussion of data integrity issues in chromatography laboratory

当前药品色谱检测中的数据完整性问题主要包括计算机化系统的访问管理、非合规测试(如单针进样、中止序列)、数据的再处理和手动积分、元数据和审计追踪、超标结果管理等,这些问题可能会影响公司产品质量的可信度,严重的可能导致上市药品的频繁召回。本文回顾国家药品监督管理局食品药品审核查验中心发布的2017年度、2021年度药品检查工作报告和美国食品药品管理局(FDA)官网近2年公布的警告信中关于药品色谱检测中的数据完整性问题,并讨论了规避上述问题的措施。

Currently,data integrity issues in drug chromatography laboratory were mainly classified as access management of computerized systems,testing into non-compliance(such as single needle injection,aborted runs),data reprocessing and manual integration,metadata and audit trail,and managing out of specification results,and so on.The reputation of company’s product quality may suffer significantly,and may cause frequent marketed drugs recalls in serious cases.This article reviews the 2017 and 2021 annual drug inspection work report issued by Center for Food and Drug Inspection of NMPA,and the warning letter published on the official website of the United States Food and Drug Administration(FDA)in the past 2 years pertaining to majority of data integrity issues in drug chromatography laboratory,and discusses measures to avoid these troubles.