Operationalizing Pharmacovigilance Gap Analysis for ATMPs and Combination Products: A System-Level Approach to Inspection Readiness

As regulatory expectations continue to evolve, inspection readiness depends on more than SOP compliance. Organizations must demonstrate integrated, end-to-end control across their pharmacovigilance ecosystem.

Here we explore:
• Why inspection findings most often occur at cross-functional interfaces rather than within isolated processes
• A practical Four-Layer Gap Analysis Model for evaluating PV system performance
• Key challenges unique to ATMPs and combination products
• Strategies to build resilient, integrated, and inspection-ready pharmacovigilance systems