By Md Saddam Nawaz
Published in: Pharmaceutical Online
Published on: April 24, 2025
In April 2025, the International Council for Harmonisation (ICH) reached Step 2 of a long-awaited revision to its stability guidance, releasing a draft ICH Q1: Stability Testing of Drug Substances and Drug Products for public consultation. This new draft guideline represents the first major overhaul of global stability testing standards in over two decades. It is a consolidated revision that will supersede the ICH Q1A–Q1F guidelines and ICH Q5C (for biotechnological products), unifying them into a single comprehensive guideline.
Compliance • Guidances • Quality • Regulatory • SOPS • Study Design
