The ICH Q1 draft Guideline on “Stability Testing of Drug Substances and Drug Products” has reached Step 2b of the ICH Process on 11 April 2025 and entered the public consultation period.
A Step 2 Informational Presentation has also been developed by the Q1 EWG.
The draft guidance document and presentation are located here under Q1 EWG.
This draft consolidates Q1A through Q1F, along with Q5C for biologic products.
