SOP: PSMF Maintenance

This Standard Operating Procedure (SOP) template describes the process for preparing, maintaining, and updating the Pharmacovigilance System Master File (PSMF) and the Summary of the Pharmacovigilance System (SPS) in accordance with EU pharmacovigilance requirements.
 
The SOP provides a structured framework defining responsibilities, timelines, and procedures to ensure that the PSMF is maintained in a compliant and inspection-ready state throughout the lifecycle of medicinal products.
 
The template includes guidance on key activities such as:
Registration of the PSMF in the EudraVigilance system
Preparation and submission of the Summary of the Pharmacovigilance System (SPS)
Roles and responsibilities of the QPPV and contributing departments
Periodic and ad hoc updates to the PSMF
Version control and document management
Availability of the PSMF for regulatory authorities
Archiving and record management
 
The procedure ensures that the PSMF remains up to date and available for regulatory authorities within the required timelines.
 
This template is particularly useful for pharmaceutical and biotechnology companies establishing or maintaining a GVP-compliant pharmacovigilance system in the EU.
 
Typical use cases
Establishing procedures for PSMF maintenance
Preparing for EU pharmacovigilance inspections
Implementing a compliant PV documentation system
Supporting MAA submissions and regulatory readiness
 
Document format
Editable template provided in Word format, allowing easy adaptation to the company’s pharmacovigilance system and internal procedures.