Tag: regulatory expectations IMP recall documentation

IMP Recall Documentation Deficiencies Cited in Audit Reports Why IMP Recall Documentation Deficiencies Appear in Regulatory Audit Findings Introduction: The Significance of IMP Recall Management Investigational Medicinal Product (IMP) recalls may be initiated due to quality concerns, protocol changes, labeling errors, or safety issues. Regulatory agencies such as the FDA, EMA, and MHRA expect sponsors,…

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