A holistic perspective on analytical method validation under International Council for Harmonisation Q2(R1)

Validation is a fundamental requirement for ensuring compliance with Good Laboratory Practices and Current Good Manufacturing Practices. Each and every pharmaceutical sector ensures testing of excipients. IPQC material like excipients, drugs packaging material, and raw materials efficiently evaluated for their efficacy study. Hence, validation of analytical methods is a necessary prerequisite for testing of pharmaceuticals. Analyzing active pharmaceutical ingredients, pharmaceuticals excipients, and finished dosage forms includes the development of analytical evaluation procedure, which is essential to provide a highly accurate, exact, and intended outcome; hence, to obtain such a precise outcome, the analytical technique needs to be verified and validated according to the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines. The ICH guideline Q2(R2), endorsed by the European Medicines Agency, offers a harmonized and updated framework for analytical procedure validation across different regulatory regions including the USA (Food and Drug Administration), Japan (Pharmaceuticals and Medical Devices Agency), and the European Union and provides a standardized framework for validating analytical methods, addressing parameters such as accuracy, precision, specificity, detection limit, quantitation limit, linearity, and range. This comprehensive review outlines the principles and key requirements of ICH Q2(R1), emphasizing its role in regulatory compliance and quality assurance. It elaborates on the fundamental aspects of method validation, including systematic approaches to evaluate method performance, criteria for acceptance, and practical implementation strategies.