ICH Q1: 20 Years of Stability and a 2025 Transformation

Stability testing and the setting of shelf lives is a fundamental component of the Chemistry, Manufacturing and Controls (CMC) development of a medicinal product and one of the most tangible aspects of quality for patients. An unfavorable shelf life can make a product economically unviable, and not having the requisite stability data can delay regulatory approval.

The original ICH Q1 Stability was one of the first guidelines to be finalised at ICH (1993). By the early 2000s multiple supplementary ICH guidelines in the Q1 series (Q1B, Q1C etc.) were endorsed as ‘subchapters’ of the “parent” Q1A(R2) stability guideline. This iterative approach was used to avoid reopening a guideline where consensus was already achieved. Since then, stability guidance for small molecules has remained – stable – while other ICH guidelines have undergone development.

Through the user experience gained with ICH Q1 implementation, uncertainties related to the interpretation of the individual guidelines and how they fit together have arisen. In the same time period there has been substantial innovation in analytical testing (including approaches as described in ICH Q2 and ICH Q14) along with the development of control strategies (ICH Q8 and Q11), Quality Risk Management principles (ICH Q9) and lifecycle approaches (ICH Q10 and ICH Q12). Collectively, this has created uncertainty for industry and regulatory agencies regarding how to assess product stability, driving the need for an ICH Q1 overhaul.

This session will:
1) Detail the planned changes to ICH Q1;
2) Using scenario based case studies illustrate the prospective changes and explain how they may impact on M3 requirements.

ICH Q1 is a keystone guideline for regulatory CMC. Session attendees will be able to learn how new stability requirements can be applied to their own projects and prepare for the biggest shakeup in stability guidance in the era of harmonisation.