Pharmacovigilance Audits and Inspections
✅ Pharmacovigilance Audits and Inspections
🔍 1. Pharmacovigilance Audits
📘 Definition:
A systematic, independent, and documented process to evaluate the pharmacovigilance (PV) system, its quality system, and compliance with regulatory requirements.
📌 Purpose:
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Ensure compliance with GVP and regulatory obligations.
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Verify effectiveness of the PV system.
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Identify risks, gaps, or deviations.
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Enable continuous improvement through CAPA.
🗂️ Key Audit Types:
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System Audits – Assess overall PV system, SOPs, QPPV responsibilities.
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Process Audits – Evaluate specific PV activities (e.g., ICSR processing, literature search).
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Product-Specific Audits – Focused on safety data and risk management of a particular product.
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Contractor/Partner Audits – Assess compliance of service providers like CROs.
🔄 Audit Cycle:
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Planning & Risk Assessment
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Conducting the Audit (on-site or remote)
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Reporting & Follow-up
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CAPA Implementation
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Effectiveness Check
🔐 Common Audit Findings:
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Delayed ICSR submissions
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Lack of QPPV oversight
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Incomplete SOPs or training records
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Poor data quality in safety databases
🕵️ 2. Pharmacovigilance Inspections
📘 Definition:
A formal examination by regulatory authorities (e.g., EMA, FDA, MHRA) to assess compliance with pharmacovigilance legislation and GVP guidelines.
🛑 Objectives:
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Ensure patient safety through regulatory compliance.
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Assess QPPV responsibilities, safety reporting, and signal management.
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Verify MAH’s obligations for post-marketing safety.
🏛️ Types of Inspections:
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Routine Inspections – Scheduled based on risk profiling or rotation.
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For-Cause Inspections – Triggered by safety concerns or serious non-compliance.
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Triggered Inspections – Due to new product launch, change in MAH, or referrals.
🔍 Key Inspection Focus Areas:
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Pharmacovigilance System Master File (PSMF)
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ICSR reporting timelines
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Risk Management Plans (RMPs)
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Signal detection and management
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Corrective and preventive actions (CAPA)
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Data integrity and safety database validation
📅 Inspection Phases:
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Pre-Inspection Notification & Request for Documents
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On-Site/Remote Inspection
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Debriefing Meeting
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Inspection Report
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Response Submission and CAPA
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Follow-up or Re-inspection
⚖️ Regulatory Guidelines Referenced
| Document | Agency/Group | Focus |
|---|---|---|
| GVP Module III | EMA | Inspections of PV systems |
| GVP Module IV | EMA | Pharmacovigilance audits |
| FDA PV Inspections Manual | FDA (CDER) | Inspection procedures in the U.S. |
| MHRA GVP Guidelines | UK MHRA | National PV inspection expectations |
| ICH E6 (R2) | ICH | GCP and sponsor responsibility in PV audits |
🧠 Summary for Interviews or Study:
| Audits | Inspections |
|---|---|
| Internal or external | Conducted by regulators |
| Proactive and planned | Reactive or risk-based |
| Focus on self-assessment | Focus on legal compliance |
| Results in CAPA | May result in warning letters, 483s, or sanctions |
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