🕵️‍♀️ GVP Module III – Pharmacovigilance Inspections

🔹 Purpose

GVP Module III provides guidance on how pharmacovigilance (PV) inspections are conducted by regulatory authorities in the EU to ensure compliance with PV obligations and to safeguard public health.

🔹 Key Objectives

• Verify the compliance of Marketing Authorisation Holders (MAHs) with EU pharmacovigilance legislation.

• Ensure effectiveness of the pharmacovigilance system in identifying, managing, and minimizing risks.

• Promote continuous improvement in pharmacovigilance practices.

🔹 Scope

Applies to:

• All MAHs operating in the EU.

• Contracted pharmacovigilance service providers.

• Third parties performing PV activities on behalf of MAHs.

🔹 Types of PV Inspections

1. Routine Inspections

   • Scheduled based on a risk-based inspection program.

   • Targeted at ensuring ongoing compliance.

2. For-Cause Inspections

   • Triggered by specific concerns (e.g., signals of non-compliance, safety issues, complaints).

   • More focused in nature.

3. Triggered by Application

   • Conducted during marketing authorisation application or variation evaluations.

   • To assess readiness and robustness of PV systems.

🔹 Inspection Process

1. Planning and Risk Assessment

   • Authorities prioritize inspections based on:

     • Product risk.

     • Compliance history.

     • Complexity of the organization.

     • Market size or public health impact.

2. Notification and Preparation

   • MAHs are informed in advance.

   • A request for pre-inspection documents (e.g., PSMF, SOPs, contracts, training logs) is issued.

3. Conduct of Inspection

   • Can be onsite or remote.

   • Includes:

     • Interviews with staff (including QPPV).

     • Review of systems, SOPs, reports, databases.

     • Checking adherence to PV obligations.

4. Inspection Report and Classification

   • Findings are classified as:

     • Critical: Significant risk to patient safety or public health.

     • Major: Could potentially impact PV activities significantly.

     • Minor: Lesser impact but still non-compliant.

5. Follow-up and CAPA

   • MAHs must provide a Corrective and Preventive Action (CAPA) plan.

   • Inspectors may conduct re-inspections if necessary.

🔹 Areas Commonly Inspected

• PSMF content and maintenance.

• QPPV qualifications, access, and oversight.

• Adverse event collection and reporting.

• Signal management.

• Risk management plans (RMPs).

• SOPs and training.

• IT systems/databases.

• Contractual agreements and oversight of third parties.

🔹 Inspection Outcomes

• Satisfactory: Minor or no findings.

• Satisfactory with conditions: Major findings needing correction.

• Unsatisfactory: Critical findings; possible regulatory consequences such as:

  • Suspension or variation of MA.

  • Referral procedures.

  • Financial penalties.

🔹 Documentation and Record-Keeping

• All records, communications, and CAPAs must be documented and maintained.

• Should be easily accessible during inspections.

🔹 Coordination of Inspections

• Carried out by national competent authorities (NCAs).

• EMA coordinates and supports inspections for centrally authorised products (CAPs).

📌 Conclusion

GVP Module III ensures that pharmacovigilance systems are inspectable, accountable, and capable of protecting public health through effective oversight. MAHs must be inspection-ready at all times and continuously improve based on inspection feedback.

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