ICH Introduces New Draft Guideline on Stability Testing

In April 2025, the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) released a draft guideline titled "Stability Testing of Drug Substances and Drug Products." This document is currently open for public consultation, with comments being accepted until the end of July 2025, except where otherwise noted on the ICH website.

This latest draft aims to consolidate and supersede the earlier ICH stability guidelines (Q1A through Q1F and Q5C). It is applicable to both active pharmaceutical ingredients (APIs) and finished dosage forms. The revised guideline reflects modern scientific advancements and incorporates risk-based methodologies and emerging technologies.

Key Sections of the Guideline Include:

1. Introduction
2. Stability Studies During Development (Stress and Forced Conditions)
3. Formal Stability Study Protocol Design
4. Batch Selection
5. Container Closure Systems
6. Testing Intervals
7. Storage Conditions
8. Photostability Testing
9. Stability Considerations for Intermediate Processing and Holding Times
10. Short-Term Storage Guidelines
11. In-Use Stability Assessment
12. Reference Standards, New Excipients, and Adjuvants
13. Data Analysis and Evaluation
14. Labelling Requirements
15. Stability in the Context of Regulatory Commitments and Lifecycle Management
16. Glossary
17. References
18. Annexes

Included Annexes:

• Annex 1: Reduced Stability Protocol Design
• Annex 2: Stability Modelling Approaches
• Annex 3: Stability Guidelines for Advanced Therapy Medicinal Products (ATMPs)

Chapters such as 1, 2, 3, 4, 7, 8, 9, 11, 12, 13, 14, and 15 feature multiple detailed sub-sections for in-depth guidance.

08-06-2025