On April 24, 2025, the Committee for Medicinal Products for Human Use (CHMP) adopted the draft ICH Q1 Guideline on Stability Testing of Drug Substances and Drug Products (Step 2b) for public consultation. The consultation period is open until 30 July 2025.
This draft guideline represents a consolidated revision, superseding the previously established ICH Q1A–F and Q5C guidelines. It offers updated and comprehensive direction on the principles of stability testing for both synthetic and biological drug substances and drug products.
The guideline outlines science- and risk-based approaches to stability strategy development, with applicability extending across the product lifecycle—from initial registration to post-approval changes and master file submissions.
Importantly, the draft integrates the principles of Quality by Design (QbD), as defined in ICH Q8–Q11 and Q14, emphasizing the critical role of manufacturing processes and critical quality attributes (CQAs) in shaping robust stability strategies.
For a complete overview of the draft guideline, you can access the full document here.
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