Abstract

A BRIEF REVIEW ON: METHOD VALIDATION

Revathi B.*, Gowthami B., Harini D., Sravya G. V. and Varsha M.

Abstract

Validation is a crucial element in meeting the standards of current good manufacturing practices (CGMP) and good laboratory practices (GLP). In every pharmaceutical company, it is essential to carry out testing on raw materials, in-process materials, final packaging, and excipients effectively. Validation of analytical methods is regarded as a fundamental requirement for testing these pharmaceutical items. For testing active pharmaceutical ingredients (APIs), excipients, and final products, a clear analytical procedure must be established. Such a wellstructured procedure should guarantee that it consistently delivers accurate results with a high level of precision. To achieve these specific outcomes, it is necessary to validate the analytical method. The process of analytical method validation involves assessing accuracy, precision, limits of detection (LOD), limits of quantification (LOQ), linearity, and range. The outcomes of method validation can be utilized to oversee the quality, dependability, and consistency of analytical outcomes, which is a core component of any robust analytical practice. Furthermore, the validation of analytical methods is mandated by the majority of regulations and quality standards that govern laboratories. The primary purpose of this review article is to provide guidance to emerging researchers on enhancing the quality of analytical method development and the validation process.

Keywords: Analytical chemistry, CGMP, GLP, Linearity, Method validation.