GVP Module IV – Pharmacovigilance Audits

🔹 Purpose

GVP Module IV provides guidance on the planning, conduct, reporting, and follow-up of audits of pharmacovigilance (PV) systems, including the role of quality assurance in maintaining PV compliance.

🔹 Key Objectives of PV Audits

• To verify compliance with legal PV obligations.

• To assess the effectiveness of the pharmacovigilance system.

• To ensure continuous improvement and minimization of risk to patient safety.

🔹 Scope

Applies to:

• Marketing Authorization Holders (MAHs)

• Sponsors of clinical trials

• Third parties performing PV activities

• Contract Research Organizations (CROs)

• QPPVs and affiliates

🔹 Audit Requirements

• Audits are a mandatory part of a pharmacovigilance quality system.

• Should be independent, objective, and risk-based.

• Must be documented and subject to follow-up.

🔹 Three-Level Risk-Based Audit Strategy

1. Strategic Level (Audit Strategy)

• High-level planning covering 2–5 years.

• Based on overall PV risk assessment.

• Should cover global and local systems, vendors, and affiliates.

2. Tactical Level (Audit Programmer)

• Yearly plan outlining specific audits to be performed in the year.

• Based on:

  • Product portfolio risks.

  • PV changes or reorganizations.

  • Previous audit outcomes.

3. Operational Level (Audit Plan & Execution)

• Detailed plan for each individual audit.

• Includes scope, objectives, timelines, auditees, and methods.

🔹 Key Audit Areas in Pharmacovigilance

• Pharmacovigilance System Master File (PSMF)

• Qualified Person for Pharmacovigilance (QPPV) oversight

• Adverse event collection and reporting

• Signal management

• Risk management systems

• Data management and safety databases

• Contracts and oversight of third parties

• Training and SOP compliance

🔹 Audit Process Steps

1. Planning and Preparation

• Define scope, objective, and criteria.

• Assign qualified audit personnel.

• Notify auditee and collect documents.

2. Conduct of Audit

• On-site or remote.

• Review of procedures, systems, and interviews.

3. Reporting

• Audit findings are classified as:

  • Critical: Potential serious risk to patients.

  • Major: Could affect PV activities significantly.

  • Minor: No significant risk but still a non-compliance.

• Audit report is shared with management and concerned teams.

4. Follow-up

• Implementation of Corrective and Preventive Actions (CAPA).

• Monitoring until closure of all findings.

🔹 Audit Documentation

• Audit reports

• CAPA plans

• Audit schedules and logs

• Evidence of CAPA implementation

• Audit trails

🔹 Role of the QPPV

• Should be aware of audit outcomes and findings relevant to the EU pharmacovigilance system.

• Should ensure CAPA is implemented for EU-related issues.

📌 Conclusion

Pharmacovigilance audits are essential to ensure a robust quality system, regulatory compliance, and protection of patient safety. A structured, risk-based audit approach ensures ongoing oversight and accountability of the PV system.

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