Abstract
In consideration of the recent ICH Quality Discussion Group (QDG) recommended revision to the ICH series of stability guidelines, the IQ Consortium (International Consortium for Innovation and Quality in Pharmaceutical Development) Science- and Risk-based Stability Working Group conducted a comprehensive review of ICH Q1A, Q1B, Q1C, Q1D, Q1E, and Q5C to identify areas where the guidelines could be clarified, updated, and amended to reflect the potential knowledge gained from current risk-based predictive stability tools and to consider other science- and risk-based stability strategies in accordance with ICH Q8–12. The recommendations propose a holistic approach to stability understanding, utilizing historical data, prior knowledge, modeling, and a risk assessment process to expand the concept of what could be included (or would be acceptable) in the core stability data package, including type and amount of stability evidence, assignment of retest period and shelf-life for a new product, and assessment of the impact of post-approval changes.
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15 November 2021
A Correction to this paper has been published: https://doi.org/10.1208/s12248-021-00646-1
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Acknowledgements
The authors would like to thank the following colleagues for the thoughtful review comments they provided on this paper: Jin Wang, Chait Wannere, Barbara Rellahan, Beth Kendsersky, Kevin Ryan, Ron Ogilvie, Clarice Hutchens, Mark D. Argentine, Michael R. De Felippis, George Daniel Willingmyre, Siqing Song, Kelly Norton, Cheryl Pape, Paul Hermes, Carolyn Gordon, Anette Skoog, Richard Bradley, Angelica Wickström, Simon Lee, Timothy Watson, and Margaret Faul.
The authors wish to dedicate this article to Helen Williams, who passed away in August 2021 after a long illness. Helen was a founding member of the IQ Working Group for Risk Based Predictive Stability and played a fundamental role in the success and growth of the group, building connections and authoring several publications. As a leader and advocate for the emerging field of predictive stability, Helen championed the acceleration of pharmaceutical development and brought energy and determination to the task of reinventing established practice. Helen was a wonderful friend and colleague, and will be profoundly missed by the pharmaceutical stability community.
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All authors contributed to the conception and design of this manuscript and the detailed recommendations listed in the supplementary material. Chi-wan Chen authored the “Introduction” section. Alexander Abbott, Andrew Lennard, Lori McCaig, Jenny Carhart, Robert Timpano, Fenghe Qiu, Dennis Stephens, Hanlin Li, Megan McMahon, and Chi-wan Chen authored the “Recommendations” section. Lori McCaig authored the “Discussion” section. Megan McMahon authored the “Conclusion” section. All authors reviewed, edited, and approved the manuscript.
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This paper was developed with the support of the International Consortium for Innovation and Quality in Pharmaceutical Development (IQ, www.iqconsortium.org). IQ is a not-for-profit organization of pharmaceutical and biotechnology companies with a mission of advancing science and technology to augment the capability of member companies to develop transformational solutions that benefit patients, regulators, and the broader research and development community.
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McMahon, M.E., Abbott, A., Babayan, Y. et al. Considerations for Updates to ICH Q1 and Q5C Stability Guidelines: Embracing Current Technology and Risk Assessment Strategies. AAPS J 23, 107 (2021). https://doi.org/10.1208/s12248-021-00641-6
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DOI: https://doi.org/10.1208/s12248-021-00641-6