ICH Q1E Evaluation of stability data - Scientific guideline

This document explains how to use stability data generated in accordance with the ICH guideline Q1A (R2) to propose a retest period or shelf life in a registration application. It covers stability studies using single- or multi-factor designs and full or reduced designs.

Keywords: Stability, stability data, evaluation, chemical active substance, finished product, herbal, evaluation, re-test period, shelf life

Current effective version

ICH: Q 1 E: Evaluation of stability data - Step 5

Adopted Reference Number: CPMP/ICH/420/02 Legal effective date: 01/08/2003