Glossary

Analytical Procedure Validation

Also writtenmethod validationanalytical method validationtest method validation

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

Source · MFDS, 「알기 쉬운 GMP 용어집」, Analytical Procedure; ICH Q2, Validation of Analytical Procedures Korean original

Related sections

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

Related terms

Analytical Procedure2 casesAccuracy467 casesPrecision29 cases

Source

MFDS, 「알기 쉬운 GMP 용어집」, Analytical Procedure; ICH Q2, Validation of Analytical Procedures Korean original

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