Stability Testing Update: The New ICH Q1 Draft Guideline - Online Training Recording
Course No. 22484
Speakers
Dr Joachim Ermer
Ermer Quality Consulting
Objectives
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.
Background
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.
Target Group
This Live Online Training is aimed at professionals from:
Quality Assurance and Quality Control
Regulatory Affairs
Product and Pharmaceutical Development
Analytical Development
Stability Testing Management
who are involved in the design, execution, evaluation, and regulatory submission of stability studies for drug substances and drug products.
Technical Details
To participate in an on demand training course or webinar, you do not need any software. The recordings are made available via a streaming server. In general, the recording is provided in MP4 format, which any PC (Microsoft Windows, Apple IOS) or tablet can easily display.
Timing and Duration: When you register for the on demand Training course or webinar you can decide at what date you want to follow the training course online. For a 1-day training course you will have 2 days in which the stream is available (for 2-day training course 3 days and for a 3-day training course 4 days). Within in this timeframe you can start & stop the stream according to your needs.
In time before the scheduled date (your desired date) you will receive an e-mail from us with a link for direct participation as well as your log-in data.
Please be aware: The recording does not include the Q & A sessions.
Training Course Documentation and Certificate: The presentations will be made available as PDF files via download shortly before the online training course. After the event, you will automatically receive your certificate of participation.
Programme
Introduction and General Principles
Scope and applications
Types of stability studies
Intermediates, in-use, and reference standard stability
Commitments and lifecycle Management
Ongoing stability studies
Stability of Advanced Therapy Medicinal Products (ATMPs)
Design of Formal Stability Studies
Development studies (stress and forced conditions)
Photostability
Stability-indicating Critical Quality Attributes
Batch selection
Testing frequency
Climatic zones and storage conditions
Data Evaluation
Start of shelf life
Statistical analysis and extrapolation (fixed effects and mixed effects models)
Enhanced stability modelling
Reduced protocol design (Bracketing and Matrixing, commitment studies)
Summary
New aspects and requirements
Challenges, gaps and issues
Potential for improvements
Recording from 18 June 2025 Duration of Recording: approx. 2h 15min
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