The International Council for Harmonisation (ICH) has published the draft revision of the ICH Q1A guideline “Stability Testing of New Drug Substances and Products”, and it is now open for public consultation until the end of July. ICH Q1 is a consolidated revision that supersedes ICH Q1A to F and Q5C guidelines and provides additional guidance on principles relating to stability.
For those of us working in Regulatory Affairs, CMC, Quality Assurance, Analytical Development, and R&D, this is a critical opportunity to help shape this pharmaceutical regulation.
The Q1 guideline establishes how we demonstrate the stability and shelf life of both drug substances and finished drug products, forming a key part of Module 3 in regulatory submissions.
This new draft reflects among others:
- Scientific advancements in stability principles
- Modernized storage conditions and testing approaches
- Improved alignment with lifecycle and QbD principles
- Emphasis on risk-based strategies and data-driven decision-making
- Clarifications for complex dosage forms and global climates
In short, it’s a significant update that will impact development timelines, regulatory strategy, and product lifecycle management across the industry.
By contributing your input during this consultation phase, you help ensure the guideline is not only scientifically sound, but also practical and implementable in real-world settings. Your expertise from daily operations, audits, regulatory interactions, and dossier preparation is exactly what these consultations need.
Whether you’re leading (global) filings, developing stability protocols, or overseeing product shelf life strategies, this is a chance to contribute meaningfully to the future of regulatory science.
Let’s ensure that evolving science is matched with realistic, high-quality standards. Your voice matters.
In need of assistance for your stability strategy, or other regulatory or quality questions? Reach out to us at [email protected] to see how we can support your company.
