摘要
Abstract
As an important tool of drug regulation,inspection plays a crucial role in ensuring drug safety and promoting industry development.In recent years,global drug inspection efforts have faced challenges such as limited resources and restrictions on conducting on-site inspections under special situations.In response,many regulatory authorities have explored and implemented various innovative inspection methods.This article reviews current global practices in drug inspection innovation and analyzes them based on key behavioral elements-seeing,listening,speaking,recording,visiting,smelling,and considering.It systematically compares on-site,remote,document,and hybrid inspections,and evaluates the advantages and disadvantages of each method through specific practices.Furthermore,the paper proposes a risk-based decision-making model to assess the feasibility of these innovative approaches,aiming to provide a reference for the high-quality and sustainable development of drug inspection practices.关键词
药品检查/检查方式/检查行为要素/检查决策模型/远程评估Key words
drug inspection/inspection methods/inspection behavioral elements/inspection decision-making model/remote assessment分类
医药卫生
