Pharmacovigilance System Master File Guidelines

1) Purpose

The purpose of this SOP is to define the process for creating, maintaining, and updating the Pharmacovigilance System Master File (PSMF) to ensure compliance with regulatory requirements.

2) Scope

This SOP applies to all personnel involved in the preparation, maintenance, and review of the PSMF within the pharmacovigilance department.

3) Responsibilities

The Pharmacovigilance (PV) Manager is responsible for overseeing the creation and maintenance of the PSMF. All PV staff must ensure accurate and timely input of relevant information into the PSMF.

4) Procedure

4.1 Creation of the PSMF

1. Identify and gather all necessary documents and information required for the PSMF.
2. Compile the information into the PSMF template, ensuring all sections are complete and accurate.
3. Review the PSMF for completeness and compliance with regulatory requirements.

4.2 Maintenance of the PSMF

1. Regularly update the PSMF to reflect any changes in the pharmacovigilance system, processes, or personnel.
2. Document any updates or changes made to the PSMF, including the date and reason for the changes.
3. Conduct periodic reviews of the PSMF to ensure it remains current and accurate.

4.3 Review and Approval

1. Schedule regular reviews of the PSMF by the PV Manager and relevant stakeholders.
2. Ensure any identified gaps or discrepancies are addressed and corrected promptly.
3. Obtain necessary approvals for the PSMF from the PV Manager and Quality Assurance (QA) department.

4.4 Archiving and Retrieval

1. Maintain electronic and/or hard copies of the PSMF in a secure and accessible location.
2. Ensure the PSMF is readily available for regulatory inspections and audits.
3. Archive previous versions of the PSMF according to the company’s document retention policy.

5) Abbreviations, if any

PSMF – Pharmacovigilance System Master File
PV – Pharmacovigilance
QA – Quality Assurance

6) Documents, if any

PSMF template, update logs, review records, approval forms.

7) Reference, if any

EU Good Pharmacovigilance Practices (GVP) Module II, ICH guidelines.

8) SOP Version

Version 1.0