Audits, Inspections, and PV Compliance Best Practices
Regulatory audits and inspections are crucial components of a robust pharmacovigilance system, ensuring compliance with national and international safety standards. Preparing for these evaluations requires well-documented processes, trained personnel, and centralized access to safety data. Common focus areas during inspections include adverse event reporting timelines, signal detection procedures, risk management plans, and vendor oversight. Gaps in documentation or process adherence can lead to significant findings and regulatory penalties. Implementing routine internal audits, mock inspections, and CAPA (Corrective and Preventive Action) systems can strengthen readiness and promote continuous improvement. Furthermore, aligning with global guidance such as ICH E2E and GVP modules enhances harmonization across regions. This session explores practical strategies for audit preparedness, successful navigation of inspections, and ongoing PV compliance management to build resilient and credible safety systems.