国际上不同分析方法验证准则概述教学教材.pptVIP

国际上不同分析方法验证的准则概述;分析方法验证是论证某一分析方法适用于其用途的过程。 Analytical method validation is the process to confirm that the analytical procedure employed for a specific test is suitable for its intended use. ;Slide *;;International regulatory bodies and their guidelines on different aspects of MV;Examples of Methods That Require Validation Documentation;Considerations Prior to Method Validation;Validation Step;Purpose of Method Validation;Validation Report;US FDA Validation Guidelines;US FDA Validation Guidelines;ICH Validation Guidelines;EU Validation Guidelines;Australian Validation Guidelines;US EPA Validation Guidelines;Validation Guidelines;Regulatory and Compliance Requirements Review;Validation Requirements Parameters ;ICH/USP Validation Requirements Parameters ;USP Categories;USP Data Elements Required For Assay Validation;ICH Validation Characteristics vs. Type of Analytical Procedure;AOAC Categories of Chemical Methods;AOAC Validation Characteristics vs. Type of Analytical Procedure;AOAC Validation Characteristics - Analyte concentration versus precision within orbetween days;AOAC Validation Characteristics - Analyte recovery at different concentrations;How do we Know the expectations of the FDA?;483 Observations ;FDA Waning Letter;FDA Systems Based Inspection:Laboratory System;Related Site