Ensuring Specificity & Robustness in Method Validation: Pharma Best Practices How to Validate Specificity and Robustness in Pharmaceutical Analytical Methods In pharmaceutical analytical method validation, specificity and robustness are crucial elements that ensure a method can consistently and reliably deliver accurate results under varying conditions. According to ICH Q2(R1), both parameters are essential for demonstrating that a method is suitable for its intended use. This guide outlines how to validate specificity and robustness in line with regulatory expectations and Good Laboratory Practices (GLP), while integrating stress testing, sample matrix analysis, and system parameter variation techniques. Regulatory References ICH Q2(R1) –…