Chapter 12: Audits and Inspections in Pharmacovigilance
Synopsis
Author
Mr. Naga Santhosh Reddy Satti,
UG Scholar, VJ's College of Pharmacy, Diwancheruvu, Rajahmundry, Andhra Pradesh, India
Abstract
The regulatory inspection represents the ultimate validation of a pharmaceutical company's compliance with Good Pharmacovigilance Practice (GVP) and Good Clinical Practice (GCP). It is a legal enforcement action where health authorities scrutinize systems, documents, and personnel to verify that patient safety is protected. Strategic preparation for inspection readiness is essential, distinguishing between internal audits, which are tools for improvement, and external inspections, which are judgments of compliance. Key to this defense is the management of the "Front Room" and "Back Room" logistics and the behavioral preparation of subject matter experts. When deficiencies are identified, they result in Inspection Findings that must be addressed through a rigorous Corrective and Preventive Action (CAPA) plan, utilizing Root Cause Analysis to eliminate systemic errors. Central to the European compliance framework is the Qualified Person for Pharmacovigilance (QPPV), a unique role carrying personal legal liability for the oversight of the entire pharmacovigilance system. Understanding the QPPV's specific responsibilities, from maintaining the Pharmacovigilance System Master File (PSMF) to ensuring 24/7 availability, is essential for understanding the high-stakes environment of regulatory oversight and ensuring that the pharmacovigilance system remains robust and compliant.
Keywords: Regulatory Inspections, Corrective and Preventive Action (CAPA), Qualified Person for Pharmacovigilance (QPPV), Inspection Readiness, Pharmacovigilance System Master File (PSMF)
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