Analytical Method Validation: A Comprehensive Review of Current Practices

Abstract

Analytical method validation is a critical process in industries such as pharmaceuticals, food safety, biotechnology, and environmental monitoring. It guarantees reliability, reproducibility, and compliance with regulatory obligations. This review covers current practices including adherence to guidelines from ICH Q2(R1), USP, and EMA. Method suitability is analyzed for its key validation parameters, including accuracy, precision, specificity, detection limits, and robustness. Validation approaches are changing with the adoption of automation, artificial intelligence (AI), machine learning, and Analytical Quality by Design (AQbD) emerging trends. The review also addresses the matrix effects, sensitivity-specificity tradeoffs, and method transfers between laboratories. Valuable use of validated methods is demonstrated in pharmaceuticals, biologics, food safety, and environmental monitoring. Chromatographic methods and lifecycle management strategies are shown to be successful in case studies. The review concludes by highlighting gaps, (such as global harmonization) and opportunities for innovation in green analytical chemistry and real-time methods.