Stability testing of existing active ingredients and related finished products - Scientific guideline

This document is an extension of the note for guidance on stability testing of new drug substances and products. It provides guidance on the information to be submitted in registration applications for existing active substances and related finished products. It is applicable to chemical active substances and related finished products, herbal drugs, herbal drug preparations and related herbal medicinal products.

Keywords: Stability, stability testing, stability data, chemical active substance, finished product, herbal, specification, storage conditions, re-test period, shelf life

Current effective version

Guideline on stability testing: Stability testing of existing active substances and related finished products - Revision 1 (Corr)

AdoptedLegal effective date: 01/03/2004Reference Number: CPMP/QWP/ 122/02 Rev. 1 corr