Further to the ICH Management Committee's endorsement of the Q1/Q5C Concept Paper and Business Plan in November 2022, the Q1/Q5C EWG was established to revise the current ICH Stability Guideline Series Q1A-F and Q5C by:
- Streamlining the series, combining the various guidelines into a single guideline focused on core stability principles;
- Promoting harmonised interpretation by addressing potential gaps and areas of ambiguity; Addressing additional technical issues, including relevant stability strategies and innovative tools that strengthen the application of risk management;
- Considering inclusion of new topics, such as stability considerations for advanced therapies.
The envisioned result is a combined guideline, ICH Q1, with integrated annexes and/or appendices that address specific topics beyond the core stability recommendations and principles. Addressing drug product types including substances, intermediates, and devices.
Further information can be found in the Q1/Q5C Concept Paper and Business Plan, which can be found on ICH site. The concept paper is also attached. ICH Quality Guidelines
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Lori McCaig
Director Global Stability Program Management
Seattle Genetics
San Jose CA
[email protected]Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer.
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