VICH GL2 Validation of analytical procedures: methodology - Scientific guideline

This document provides recommendations on how to consider the various validation characteristics for each analytical procedure. It is complementary to the parent document - VICH GL1 Validation of analytical procedures: definition and terminology.

Keywords: Validation, analytical procedures, accuracy, precision, specificity, detection limit, quantitation limit, linearity, range, VICH, veterinary medicinal product (VMP)

Current effective version

VICH GL2: Validation of analytical procedures: Methodology - Step 7 consensus guideline

Adopted Reference Number: CVMP/VICH/591/98-FINAL Legal effective date: 01/10/1999