Discussion of data integrity issues in chromatography laboratory
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.
data integritycomputerized systemchromatography laboratory
万方数据
维普
