Comparative Analysis of Analytical Method Validation Requirements Across ICH, USP, ChP and ANVISA: A Review

Abstract

This comprehensive guide provides a detailed comparison of analytical method validation requirements across four major regulatory bodies: the International Council for Harmonisation (ICH), United States Pharmacopeia (USP), Chinese Pharmacopoeia (ChP), and Brazilian Health Regulatory Agency (ANVISA). The study examines key aspects of method validation, including scope, validation parameters, acceptance criteria, and regulatory compliance. These guidelines have been chosen due to major differences between regulations requirements and ICH guidelines, leading to a huge challenge for the Health Authority and the locally established Pharmaceutical Companies to implement these guidelines. Implementing the revised or upcoming ICH guidelines will benefit the industry and health authorities. Recent revisions by the guidelines will help to align with other chosen regulatory authorities to reduce duplicate work and contribute to the global regulatory harmonization, which will bring a great benefit to the regulatory bodies review process, industrialist approval and important medicines approval will be faster available to the patients.