ICH Harmonised Guideline

INTERNATIONAL COUNCIL FOR HARMONISATION OF TECHNICAL

REQUIREMENTS FOR PHARMACEUTICALS FOR HUMAN USE

ICH HARMONISED GUIDELINE

STABILITY TESTING OF DRUG SUBSTANCES AND DRUG PRODUCTS

Q1

Draft version

Endorsed on 11 April 2025

Currently under public consultation

At Step 2 of the ICH Process, a consensus draft text or guideline, agreed by the appropriate ICH Expert Working Group, is transmitted by the ICH Assembly to the regulatory authorities of the ICH regions for internal and external consultation, according to national or regional procedures.