[Anonymous]

Reply To: Clinical Supply Return Reconciliation

Agreed that full traceability is required for IMP accountability. As mentioned that return reconciliation involves a combination of both GCP and GMP, how do the GMP guidelines followed by a sponsor or vendor depot interact with 21 CFR 312 accountability guidelines? This discussion continues to arise within the Clinical QA department on where the delineation is between Clinical Operations and Clinical Supply with roles and responsibilities of this activity. As understood, manufacture, package, and distribution, and returns, and destruction of IMP supporting clinical studies follow the 21CFR211 guidelines.