Unit 4: Analytical Method Validation
This unit delivers a comprehensive and updated review of analytical method validation in line with ICH Q2(R2) and ICH Q14 guidelines, integrating modern lifecycle, AQbD, and risk-based approaches. Each validation parameter—specificity, accuracy, precision, LOD/LOQ, linearity, range, robustness, and system suitability—is defined, described, and contextualized with recent literature to reflect current industry practices.
Analytical method validation provides documented evidence that an analytical procedure is suitable for its intended purpose. The recent ICH Q2(R2) guideline emphasizes a lifecycle and risk-based validation approach to ensure consistent performance and regulatory compliance.
Key Points
Demonstrates method suitability and reliability.
Incorporates risk and lifecycle management.
Aligns with ICH Q2(R2) and Q14 principles.
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