🗂️ GVP Module II: Pharmacovigilance System Master File (PSMF)

🔹 Purpose

GVP Module II provides guidance on the structure, content, maintenance, and location of the Pharmacovigilance System Master File (PSMF), a key document required for all Marketing Authorization Holders (MAHs) in the EU.

🔹 Key Definitions

• Pharmacovigilance System: A system used by the MAH to monitor the safety of authorized medicinal products and detect any change to their risk-benefit balance.

• PSMF: A detailed, continuously updated file describing the pharmacovigilance system of the MAH.

🔹 Objectives of the PSMF

• Document the pharmacovigilance system in place.

• Demonstrate compliance with pharmacovigilance requirements.

• Facilitate supervision by competent authorities.

🔹 PSMF Requirements

1. Location:

   • Must be located within the EU.

   • Must be readily accessible to the Qualified Person for Pharmacovigilance (QPPV).

   • Should be available for inspection at the site where the main pharmacovigilance activities are conducted.

2. QPPV Oversight:

   • QPPV must have access and oversight of the PSMF.

   • Their details must be clearly recorded.

🔹 Structure and Content

PSMF should be structured into five main modules:

1. Module 1 – Qualified Person for Pharmacovigilance (QPPV)

   • Contact details and CV of the QPPV.

   • Responsibilities and authority.

2. Module 2 – Organizational Structure

   • Overview of the global pharmacovigilance system.

   • Key staff and partners involved in PV activities.

3. Module 3 – Sources of Safety Data

   • Description of data collection (e.g., spontaneous reports, literature, clinical trials).

   • Databases used.

4. Module 4 – Computerized Systems

   • Information systems and tools used for PV.

   • Data integrity and backup systems.

5. Module 5 – Quality System

   • Procedures, audits, CAPA, training, SOPs.

   • Documentation and compliance metrics.

Additional Annexes should include:

• List of products covered under the PSMF.

• List of SOPs, audits, contracts, training logs.

🔹 Maintenance of the PSMF

• Must be accurate and up-to-date.

• Should reflect any organizational or procedural changes.

• Regular updates are required (typically every quarter or with any significant change).

🔹 Inspections and Access

• The PSMF must be available on request by regulatory authorities.

• Should be presented during pharmacovigilance inspections.

🔹 Global vs. EU-specific PSMF

• While some companies may have a global PV system, an EU-specific PSMF must be maintained in line with EU legislation.

• Cross-referencing global systems is allowed if clearly described and accessible.

📌 Conclusion

The PSMF is a living document essential for demonstrating the robustness and compliance of a pharmacovigilance system. It ensures that MAHs maintain transparency, accountability, and readiness for regulatory scrutiny.

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