Significance of Method validation
Method validation is the comprehensive process used to demonstrate that an analytical method is suitable for its intended purpose as per ICH guidelines. It involves confirming parameters such as accuracy, precision, specificity, linearity, and robustness. By validating an analytical method, researchers ensure its reliability and effectiveness in various applications, including pharmaceutical analyses and quality control. This rigorous process supports regulatory submissions and guarantees that the methods can reliably measure the desired analytes in various samples, ensuring product quality assessment.
Synonyms: Process validation, Confirmation, Corroboration, Accreditation, Qualification, Assessment, Authentication
The below excerpts are indicatory and do represent direct quotations or translations. It is your responsibility to fact check each reference.
The concept of Method validation in scientific sources
Method validation is the process of confirming the reliability, accuracy, and suitability of a spectrophotometric method for estimating Domapridone, ensuring it meets ICH guidelines and is appropriate for its intended analytical purpose.
From: The Malaysian Journal of Medical Sciences
(1) The process of confirming that an analytical method is reliable and produces accurate results based on defined criteria.[1]