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Analytical method validation (Analytical Tests (Precision (repeatability,…
Analytical method validation
Guidelines
Guidance for Analytical Method validation (FDA, 1987)
Validation of Analytical Methods ICH Q2A+B (1995)
USP, EP, BP Pharmacopeia
Analytical Procedures and Methods Drugs and Biologics (Centre for Drug Evaluation and Research, 2015) - Supercedes FDA 1987
Legislation
FDA
FDA requires users of compendial methods to be demonstrate that they are competent in running the method.
21 CFR 211.194 (a) requires that all analytical methods used in the industry to be tested under actual conditions of use
Analytical Tests
Specificity
Linearity
Limit of Quantification
Range
Limit of Detection
Robustness
Accuracy
System suitability
Precision
repeatability, intermediate repeatability and reproducibility