ICH publishes Training Materials on Q2(R2) and Q14

On 9 July 2025, the International Council for Harmonisation (ICH) announced the release of comprehensive training materials on ICH Q2(R2) “Validation of Analytical Procedures” and ICH Q14 “Analytical Procedure Development.” These resources, developed by the Q2(R2)/Q14 Implementation Working Group (IWG), aim to support a harmonised global understanding and consistent application of the new guidelines across ICH and non-ICH regions. The training materials illustrate both minimal and enhanced approaches to analytical development and validation.

The following training modules, all published on 8 July 2025, are now available:

• Module 1: Step 4 Presentation for ICH Q2(R2) and ICH Q14
• Module 2: Fundamental principles of ICH Q2(R2)
  - Part A: Analytical Procedure Validation Strategy
  - Part B: Details of Validation Terms
  - Part C: Combined Accuracy and Precision
  - Part D: Considerations when Setting Performance Criteria
• Module 3: Practical Applications of ICH Q2(R2)
  - Part A: ICH Q2(R2) Annex 1 and 2
  - Part B: Other Validation Topics
• Module 4: ICH Q14 General Considerations
  - Part A: Minimal and Enhanced Approach
  - Part B: Analytical Procedure Lifecycle
  - Part C: Analytical Target Profile (ATP)
  - Part D: Risk Assessment in Analytical Procedure Development
  - Part E: Robustness and Parameter Ranges
  - Part F: Analytical Procedure Control Strategies
• Module 5: Further Concepts in ICH Q14
  - Part A: Established Conditions and the Link to ICH Q12
  - Part B: Change Management: Identification of ECs/Reporting Categories and the Use of the Decision Tree
  - Part C: Knowledge and Risk-Based Change Management
  - Part D: Explanation of ICH Q14 Tables 1 and 2, Implementation of Changes, and Bridging Studies
  - Part E: Submission Requirements in ICH Q14 Chapter 10
• Module 6: Multivariate Analytical Procedures
  - Part A: Introduction
  - Part B: Examples
• Module 7: Additional Case Studies and Examples

All modules are available for download on the ICH Q2(R2)/Q14 IWG webpage and in the ICH Training Library.