VICH GL1 Validation of analytical procedures: definition and terminology - Scientific guideline

This document presents a discussion of the characteristics for consideration during the validation of the analytical procedures included as a part of registration applications submitted within the European Union, Japan and USA.

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

Current effective version

VICH GL1: Validation of analytical procedures: Definition and terminology - Step 7 consensus guideline

Adopted Reference Number: CVMP/VICH/590/98-FINAL Legal effective date: 01/10/1999