Analytical Procedure Validation

Demonstrating, through performance characteristics and criteria, that an analytical procedure performs suitably for its intended purpose.

Related sections

ICH Q2(R2) §§2–4 21 CFR 211.160 21 CFR 211.165

Related terms

Analytical Procedure2 casesAccuracy462 casesPrecision45 cases

Source

식품의약품안전처, 「알기 쉬운 GMP 용어집」, Analytical Procedure; ICH Q2, Validation of Analytical Procedures