Published in: ICH Database

Published on: November 15, 2022

Introductory Paragraph: Revision of the ICH Stability Guideline Series Q1A-F and Q5C is recommended to a) streamline the series by combining the various guidelines into a single guideline focused on core stability principles; b) promote harmonised interpretation by addressing potential gaps and areas of ambiguity; c) address additional technical issues, including relevant stability strategies and innovative tools that strengthen the application of risk management; and d) consider inclusion of new topics, such as stability considerations for advanced therapies. The informal working group proposes to establish these updates through the Revision procedure. The envisioned result is a combined guideline, ICH Q1, with integrated annexes and/or appendices that address specific topics beyond the core principles on stability recommendations and to address product type1 specific recommendations, as required. It is also recommended to update and supplement current training material.

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