GMP-Compliant Procedures for Investigational Product Returns in Clinical Trials
IP returns ensure that all distributed investigational drugs are accounted for, particularly those not dispensed to subjects. This not only supports inventory management but also safeguards against unauthorized use, reduces wastage, and enables final reconciliation before destruction or repurposing. As per USFDA and ICH Q7 guidelines, sponsors are responsible for implementing traceable and auditable return processes.
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