The Pharmacovigilance System Master File is the single document that describes how a company keeps its medicines safe. When an inspector arrives, it is often the first thing they ask to see — and the first place problems show.
The PSMF requirement stems from Directive 2001/83/EC, with detailed content rules in Commission Implementing Regulation (EU) No 520/2012 and best-practice expectations in GVP Module II. A single PSMF describes the marketing authorisation holder’s pharmacovigilance system across all its authorised products.
Structure
The PSMF has three parts: a cover page, a main body describing the system, and annexes. The main body covers the QPPV and their responsibilities, the organisational structure, sources of safety data, the computerised systems used, the pharmacovigilance processes, and the quality system that holds it all together.
Where it must live
The PSMF must be located within the EU/EEA — either where the company’s main pharmacovigilance activities are performed or where the QPPV operates — and be permanently and immediately available to authorities.
The logbook
A mandatory logbook records changes to the system, particularly to significant service arrangements and to the PSMF content itself, with dates. It provides the traceability that lets an inspector follow how the system has evolved — and an incomplete logbook is a common finding.
Why inspections go wrong
The most frequent problems are simple: a PSMF that no longer reflects how the company actually operates, an out-of-date or incomplete logbook, missing annexes such as the list of PSURs or the contracts covering delegated activities, and unclear QPPV oversight. Each signals weak system control — and typically triggers corrective actions and deeper inspection sampling.
How PQRA helps
PQRA authors and maintains PSMFs, keeps the logbook and annexes current, and prepares companies for pharmacovigilance inspections.
No responses yet