Leverage ICH Q12 to Align Stability Strategy with Lifecycle Management
Understanding the Tip: What is ICH Q12 and its relevance to stability studies: ICH Q12 provides a framework for managing post-approval changes in a structured, science-based, and risk-driven manner. It supports predictability and efficiency in regulatory processes, enabling manufacturers to implement certain changes—such as stability study modifications—without resubmitting full dossiers every time. By aligning your…
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