广东药科大学学报2025，Vol.41Issue(5)：27-31,5.DOI:10.16809/j.cnki.2096-3653.2025061601
控制图在不溶性微粒测定中的应用
The application of control chart in the determination of insoluble particles
摘要
Abstract
Objective To establish a quality control chart for insoluble particle determination.Methods Based on the Guidance on Internal Quality Control in Chemical Analysis Laboratory,the quality control chart application procedure for drug testing laboratories was developed using the determination of insoluble particles as an example.Results The quality control chart for the determination of insoluble particles was established and practically applied.All measured control values were observed to fall within the established upper and lower action limits,demonstrating that the analytical process remained in a state of statistical control.Conclusion Applying control charts in drug testing laboratories enables real-time monitoring of whether the analytical system is out of control or undergoing changes.This allows for timely intervention and reduces laboratory risks.关键词
控制图/不溶性微粒测定/内部质量控制/药品检验实验室Key words
control chart/determination of insoluble particles/internal quality control/drug testing laboratories分类
医药卫生引用本文复制引用
吴婷,杨文凤,欧阳颖怡,张慧文,伍良涌..控制图在不溶性微粒测定中的应用[J].广东药科大学学报,2025,41(5):27-31,5.基金项目
广东省市场监督管理局科研项目(2021CB03) （2021CB03）
