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

Wednesday, 18 June 2025 9 .30 - 12.30 h

Course No. 22412

header-image

Speakers

Dr Joachim Ermer

Dr Joachim Ermer

Ermer Quality Consulting

All times mentioned are CEST.

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.

Date & Technical Requirements

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

Technical Requirements
We use WebEx for our live online training courses and webinars. At www.gmp-compliance.org/training/online-training-technical-information you will find all the information you need to participate in our trainings and you can check if your system meets the necessary requirements to participate. If the installation of browser extensions is not possible due to your rights in the IT system, please contact your IT department. WebEx is a standard nowadays and the necessary installation is fast and easy.

Programme

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

Seminar Programme as PDF

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

ECA-Member*: € 590,-
Regular Fee*: € 690,-
EU/GMP Inspectorates*: € 590,-
APIC Member Discount*: € 640,-

(All prices excl. VAT). Important notes on sales tax.

* also payable by credit card
American Express Visa Mastercard

icon
Additional dates on-site
Additional dates on-site
not available
icon
Additional dates online
Additional dates online
not available
icon
Recording
Not available

Do you have any questions?

Please contact us:
Tel.: +49 6221 8444-0
E-Mail: info@gmp-compliance.org

Woman with headset

Go back

Testimonials about our courses and conferences

"Great material and speakers" and "Great speakers a lot of experience and sharing"

Felipe Gonzalez, Mucos Emulsionsgesellschaft mbH
Live Online Training - Granulation & Tableting, September 2024

"I am so grateful for having attended this course. Great job from all, and very profitable. Thanks!”

Alba Aranda Cuesta, Kern Pharma
KPIs and Quality Metrics, Berlin, Germany, April 2025

"The lectures were very informative, interesting and entertaining."

Albert Godoy Hernández, Company synaffix
Live Online Training - GMP Auditor Practice, October 2024

"Really useful training which I will use in my daily work."

Regina Mommaerts, Galapagos NV
Live Online Training - GMP Auditor Practice, October 2024

"Wonderful format of the sessions: Good range of participations and experience in the team. Would love to attend another one soon."

Roopasi Mathi, Wacker Biotech B.V.
Live Online Training - GMP Auditor Practice, October 2024

"Very good balance between general and detailed information"

Dr Ralf Albrecht, Tillotts Pharma AG
Live Online Training - Granulation & Tableting
September 2024

"Nice presentations: easy understanding, quite visual"

Susana Manrique, Boehringer Ingelheim España, S.A,
Live Online Training - Granulation & Tableting, September 2024

“Fantastic course – I really enjoyed the interactive structure & greatly appreciate social activity.”

Anthony Cummins, Sebela Pharmaceuticals, Ireland
GMP Auditor Practice, September 2023

 

“Very well organized, information on point without being overwhelming.”

Eleni Kallinikou, Pharmathen
Live Online Trainng - Pharmaceutical Contracts - Febuary 2024

 

“Good overview of different types of agreements, good to see both the GMP and the legal angle”

Ann Michiels, Johnson&Johnson
Live Online Trainng - Pharmaceutical Contracts, Febuary 2024

 

 

“Both, organizers and lecturers were very friendly, open for discussions and extremely constructive. The course was a valuable experience for me.”

Maria Dimitrova, NKN Law Firm
Pharmaceutical Contracts: GMP and Legal Compliance, March 2025