New ICH Q1 Draft Guideline - What’s Changing in Stability Testing
Recommendation
Wednesday, 18 June 2025 9 .30 - 12.30 h
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On 11 April 2025, the new draft of ICH Q1 "Stability Testing of Drug Substances and Drug Products" reached Step 2b of the ICH process. Shortly thereafter, at the end of April, the European Medicines Agency (EMA) also made the draft guideline available for public comment. The comment period ends on 30 July 2025.
The new ICH Q1 Guideline is a comprehensive revision of the former Q1A–F and Q5C Guidelines. It expands the scope to synthetic and biological drug substances and products, including vaccines, gene therapies, and combination products, and introduces lifecycle stability management aligned with ICH Q12. The draft includes all climatic zones to support global harmonization and adds guidance for clinical use and reference standards. Key updates address stability considerations for ATMPs and emphasize Quality by Design and risk-based approaches as described within ICH Q8-Q11 and Q14.
Against this background, the ECA is offering a compact, 3-hour Live Online Training on 18 June 2025 from 09.30 to 12.30 h CEST.
The speaker, Dr Joachim Ermer, will address the following aspects:
- Stability data expectations for drug substances and drug products
- Application to synthetic and biological drug substances and drug products, including vaccines and Advanced Therapy Medicinal Products (ATMPs), and intermediates
- Development, formal (primary, commitment, ongoing and product lifecycle) and supportive (photostability, in-use, short-term) stability studies
- Establishment of re-test period or shelf life, including statistical data analysis and extrapolation
- Enhanced stability modelling
The training is designed to provide participants with a clear overview of changes, new aspects, and interpretations of the upcoming regulatory expectations with respect to the stability strategy. Inconsistencies, gaps, and opportunities for improvement will be discussed. The training might also support assessments for potential implementation challenges and issues and encourage participants to participate in the public consultation.
