The following guideline outlines the stability data expectations for drug substances and drug products.
This guideline is applicable to marketed drug products, including those associated with registration and
lifecycle/post-approval changes and, when applicable, master files.
These applications are hereafter collectively referred to in the guideline as regulatory submissions. ICH Q1 is a consolidated revision that supersedes ICH Q1A-F and Q5C guidelines and provides additional guidance on principles relating to stability
ICH HARMONISED GUIDELINE
STABILITY TESTING OF DRUG SUBSTANCES AND DRUG PRODUCTS
Draft version
Endorsed on 11 April 2025