ICH分析方法验证指南--方法论.pdfVIP

ICH Q2 (R1) ICH Q2 (R1) 简介 INTRODUCTION 简介 INTRODUCTION This document is complementary to the parent document, which presents a discussion of  This document is complementary to the parent document, which presents a discussion of  the characteristics that should be considered during the validation of analytical procedures.  the characteristics that should be considered during the validation of analytical procedures.  Its purpose is to provide some guidance and recommendations on how to consider the  Its purpose is to provide some guidance and recommendations on how to consider the  various validation characteristics for each analytical procedurIen. some cases (for example,  various validation characteristics for each analytical procedurIen. some cases (for example,  demonstration of specificity), theo verall capabilities of a number of analytical procedures in  demonstration of specificity), theo verall capabilities of a number of analytical procedures in  combination may be investigate din order to ensure the quality of the drug substance or  combination may be investigate din order to ensure the quality of the drug substance or  drug product. In addition, the document provides an indication of the data, which should be  drug product. In addition, the document provides an indication of the data, which should be  presented in a registration application.  presented in a registration application.  本文作为前文的补充，旨在讨论在分析方法验证过程中在每一个具体的项 目需要考虑哪些内 本文作为前文的补充，旨在讨论在分析方法验证过程中在每一个具体的项 目需要考虑哪些内 容。本文的目的是就不同类型的验证该涵盖哪些项 目提供一个指导原则和建议。以专属性为 容。本文的目的是就不同类型的验证该涵盖哪些项 目提供一个指导原则和建议。以专属性为 例，为了确保原料药或制剂的质量，需要考察分析过程对化合物中杂质的全面综合分析能力。 例，为了确保原料药或制剂的质量，需要考察分析过