Vidya. R. Ugale, Dr.Swati S.Rawat, Dr. Sunil S. Jaybhaye, Mr. Yogiraj P. Muley , Ms. Komal D. Kangne
Institute of Pharmacy, Badnapur, Dist. Jalna., Maharashtra
Abstract
Analytical method validation is a critical step in ensuring the accuracy, precision, and reliability of analytical results. This review article provides an overview of the Current practices and regulatory requirements for analytical method validation. The Article discusses the importance of method validation, the different types of Validation (full, partial, and cross-validation), and the performance characteristics That need to be evaluated (accuracy, precision, specificity, sensitivity, linearity, Range, robustness, and ruggedness). The regulatory requirements for method Validation from various agencies such as the US FDA, ICH, and ISO are also Discussed. The article highlights the challenges and limitations of method validation And provides guidance on best practices for validating analytical methods. Additionally, the article reviews the different statistical tools and techniques used in Method validation, including regression analysis, analysis of variance, and Measurement uncertainty. The review concludes by emphasizing the importance of Method validation in ensuring the quality and reliability of analytical results.
Keywords: Validation, precision, specificity, accuracy, ICH guidelines
Journal Name :
EPRA International Journal of Research & Development (IJRD)

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Published on : 2024-11-23

Vol : 9
Issue : 11
Month : November
Year : 2024
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