A strategy for population pharmaceutical quality assessment based on quality by design

作     者：Yu Zhao Changqin Hu Shangchen Yao Lihui Yin Xiaomei Ling Yu Zhao;Changqin Hu;Shangchen Yao;Lihui Yin;Xiaomei Ling

作者机构：NMPA Key Laboratory for Quality Research and Evaluation of Chemical DrugsNational Institutes for Food and Drug ControlBeijing102629China Acedemy for Advanced Interdisciplinary StudiesPeking UniversityBeijing100088China Peking University Health Science CenterPeking UniversityBeijing100191China 

出 版 物：《Journal of Pharmaceutical Analysis》 (药物分析学报（英文版）)

年 卷 期：2021年第11卷第5期

页      面：588-595页

核心收录：

学科分类：1007[医学-药学(可授医学、理学学位)] 10[医学] 

基　　金：The National Major Scientific and Technological Special Project for‘Significant New Drugs Development’(Grant No.:2017ZX0901001-007)provides support for this study 

主　　题：Population pharmaceutical quality Quality by design(QbD) Crucial evaluation attributes(CEAs) Process indicators(PIs) Improved statistical process control(SPC) Risk assessment 

摘      要：From a regulatory perspective,drug quality consistency evaluation must concern different processes used for the same *** this study,an assessment strategy based on quality by design(QbD)was developed for population pharmaceutical quality evaluation.A descriptive analysis method based on QbD concept was first established to characterize the process by critical evaluation attributes(CEAs).Then quantitative analysis method based on an improved statistical process control(SPC)method was established to investigate the process indicators(PIs)in the process population,such as mean distribution,batch-to-batch difference and abnormal quality *** that rules for risk assessment were established based on the SPC limitations and *** the SPC parameters of the CEAs and the risk of PIs were visualized according to the interaction test results to obtain a better understanding of the population pharmaceutical ***,an assessment strategy was built and applied to generic drug consistency assessment,process risk assessment and quality trend *** strategy demonstrated in this study could help reveal quality consistency from the perspective of process control and process risk,and further show the recent development status of domestic pharmaceutical production *** addition,a process risk assessment and population quality trend tracking provide databased information for *** only can this information serve as a further basis for decisionmaking by the regulatory authority regarding early warnings,but it can also reduce some avoidable adverse *** continuous addition of data,dynamic population pharmaceutical quality is meaningful for emergencies and decision-making regarding drug regulation.