Introduction to Guidelines of Measurement Uncertainty in the Field of Pharmaceutical Analysis
Objective:To provide a basis for the promotion and application of measurement uncertainty evaluation in domestic pharmaceutical analysis,this review sorts and summarizes the measurement uncertainty guidelines on pharmaceutical analysis that can be referenced from international to national.Methods:The history of measurement uncertainty,the main evaluation methods and the scope of application of various guidelines were summarized mainly through searching,reviewing and comparing guidelines.Results:International measurement uncertainty guidelines can be roughly divided into two categories based on the different methods used to evaluate measurement uncertainty:Bottom-up approach and Top-down approach.Multiple national guidelines are formulated based on the corresponding international guidelines issued earlier,and this review also outlines the relationship between current international and national guidelines.In addition,this review introduces a series of documents on measurement uncertainty evaluation published by drug regulatory agencies in various countries and regions.Conclusion:Whether it is the guidelines related to measurement uncertainty evaluation or laboratory quality management documents,even the relevant introductions in various national and regional pharmacopoeias,they are all a summary of a large number of practices.Carefully reading the relevant content can help pharmaceutical analysts better understand and apply the measurement uncertainty evaluation,and promote its continuous development in pharmaceutical analysis.
万方数据
维普
