SOPREFERENCE OUTLINE

Pharmacovigilance System Master File (PSMF)

Standing description of the pharmacovigilance system a marketing authorisation holder operates: the QPPV role and its authority, delegated activities and the agreements governing them, the safety database, the quality system with its performance indicators, and the change logbook. Maps to EU GVP Module II and Reg. (EU) 520/2012.

What a template is not

A template is a document baseline to adapt inside your own quality system. SPEQ does not approve, validate, or take responsibility for what you issue from it, and using one is not evidence of compliance.

CHECKING ACCESS

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REGULATIONS MAPPED
EU GVP ModulesReg. (EU) 520/2012
DOCUMENT TYPE
SOP
LAST UPDATED
August 2026
PURPOSE

The standing description of the pharmacovigilance system a marketing authorisation holder uses to monitor the safety of its authorised products. It is not a policy document: every statement in it is a claim an inspector can walk into your organisation and test. The characteristic finding is a file that reads as intention — describing the system you are building rather than the one you operate today.

What's Inside

✓Master file identification and location, with the QPPV’s operating location stated rather than implied
✓The QPPV role: authority, back-up arrangement and the contact route available outside working hours
✓Organisational structure with each delegated activity tied to a current, referenced written agreement
✓Safety database and computerised systems with validation references and the version currently in use
✓Quality system: procedures, training, records, audits and CAPA, with performance indicators carrying real values
✓Annexes holding the evidence the narrative claims, so a reader can move from claim to record
✓Logbook of changes to the file itself, dated, showing whether it tracks the system or lags it

How to Use It

1Describe the system you operate, not the one you intend to operate; a master file reading as aspiration is the characteristic finding.
2Give every delegated activity a current agreement reference; an activity delegated under an expired agreement is the same finding as one delegated under none.
3Show current values against your performance indicators; indicators carrying no values describe a system nobody is actually monitoring.
4Keep the logbook current — it is read first, because it shows whether the file tracks the system or lags it.
5Make the file retrievable within the committed time, and rehearse that retrieval before anyone requests it.
6Review the file whenever the system changes, not only on a calendar cycle; structural change is what makes it stale.
DOCUMENT CONTENTS

The full section structure of this template — every section and sub-section, so you can use it as a baseline for your own site document.

—Document Control
› Document Information› Approval Signatures› Revision History› Distribution List
1Master File Identification
2Qualified Person for Pharmacovigilance
3Organisational Structure and Delegated Activities
4Safety Database and Computerised Systems
5Quality System and Its Performance
6Annexes and Logbook
REGULATORY CONTEXT

EU GVP Module II governs the pharmacovigilance system master file and Commission Implementing Regulation (EU) 520/2012 sets its minimum content. Between them they fix what must be described and kept available; they do not design your organisation, choose your performance indicators, or decide which activities you delegate and on what terms. Those are the marketing authorisation holder’s determinations, and the file is where they become inspectable. The structure and practitioner guidance here are SPEQ’s synthesis.

MAPPED STANDARDS
EU GVP ModulesReg. (EU) 520/2012
Browse the standards catalog →