Validating Analytical Accuracy, Precision & Linearity in Pharma Labs How to Validate Analytical Accuracy, Precision & Linearity in Pharmaceutical Testing Analytical method validation ensures that laboratory procedures produce reliable, reproducible, and regulatory-compliant results. Among the core validation parameters defined in ICH Q2(R1), three play a pivotal role in establishing method performance: Accuracy, Precision, and Linearity. This guide provides step-by-step instructions for validating these characteristics, complete with example calculations, acceptance criteria, and practical insights tailored for pharmaceutical quality control (QC) and regulatory environments. Regulatory Framework ICH Q2(R1): Guidelines for Validation of Analytical Procedures FDA Guidance for Industry: Analytical Procedures and Methods…