Stability Testing Update: The New ICH Q1 Draft Guideline - Live Online Training

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 aim of this Live Online Training is to provide you with an 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 your assessment for potential implementation challenges and issues and encourage you to participate in the public consultation.

Stability testing is a fundamental part of pharmaceutical development and quality assurance. It provides evidence on how the quality of a drug substance or drug product varies over time under the influence of environmental factors such as temperature, humidity, and light. Well-designed stability programs are important to support regulatory submissions, product lifecycle management, and risk-based decision-making in the pharmaceutical industry, with a huge economic impact.

The new ICH Q1 Guideline represents a comprehensive revision and consolidation of the former ICH Q1A–F and Q5C Guidelines. The scope was extended to cover both synthetic and biological drug substances and drug products, including vaccines, gene therapies, and combination products. The concepts can also be applied to clinical stability investigations, proportionate to the increasing level of understanding during pharmaceutical development, and to reference standards.
An important extension is the coverage of post-approval changes and the stability life-cycle management, in alignment with the ICH Q12 Guideline. The new Q1 Draft includes all climatic zones and thus can achieve a real worldwide harmonization.

The general principles outlined and discussed in ICH Q1A–F are greatly expanded to biological products to provide much more comprehensive orientation than given in ICH Q5C. Stability considerations for gene therapy products (e.g. Advanced Therapy Medicinal Products (ATMPs) are newly added.

The principles of Quality by Design and risk-based approaches described within ICH Q8 to Q11, and their impact on the overall stability strategy are an important complementation, as for all recent ICH Guideline revisions. This is in particular important for alternative and scientifically justified approaches that encompass the variety of different situations that may be encountered.

Date of the Live Online Training
Wednesday, 18 June 2025, 09.30 – 12.30 h
All times mentioned are CEST.

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