PLANREFERENCE OUTLINE

Pharmacovigilance Inspection Readiness Plan

Readiness plan built on the premise that an inspection tests whether the system on paper is the system in operation. Covers master-file reconciliation with a gap log, case-walkthrough rehearsal on adversely selected cases, compliance metrics with explanations prepared, evidenced oversight of delegated activities, and briefing. Maps to EU GVP Module III 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.

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

A pharmacovigilance inspection tests whether the system described on paper is the system in operation. Preparation is therefore not document assembly — it is closing the distance between the two before an inspector measures it for you. The usual failure is rehearsing on the cleanest available cases, which proves only that the easy path works and leaves the delegated, late and complex ones untested.

What's Inside

✓Scope statement naming the sites, products and delegated parties the inspection can legitimately reach
✓Master file reconciliation table with each gap found, its named owner and a closure date
✓Case-processing walkthrough rehearsal using adversely selected cases rather than the cleanest ones available
✓Compliance metrics with current values and a prepared explanation for each, including the favourable ones
✓Oversight of delegated activities, with the artefact that evidences each one named explicitly
✓Procedure currency check confirming what staff actually do matches the version currently in force
✓Briefing for those answering questions, covering scope of answer and escalation of genuine uncertainty

How to Use It

1Select rehearsal cases the way an inspector would — late, complex, or from delegated parties — never the cleanest available
2Where the master file and reality differ, correct the file and log it; self-detected corrections read better than none
3Prepare an explanation for every metric, including the good ones, since uniformly excellent figures invite disbelief rather than confidence
4Name the artefact evidencing oversight of each delegated activity, because oversight asserted only in a contract is a standard finding
5Confirm staff follow the current procedure version, not the one they were trained on two revisions ago
6Brief responders to answer what was asked and escalate what they do not know, rather than improvising an answer
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
1Scope and Premise
2Master File Reconciliation
3Case-Processing Walkthrough Rehearsal
4Compliance Metrics
5Oversight of Delegated Activities
6Training, Procedures and Briefing
REGULATORY CONTEXT

EU GVP Module III covers pharmacovigilance inspections — their scope, conduct and the system elements examined — and Reg. (EU) 520/2012 sets the system requirements an inspection tests against, including the master file. Neither tells you which gaps to close first, what a defensible metric looks like for your portfolio, or how much rehearsal is enough — those determinations belong to the marketing authorisation holder. The readiness sequence and the adverse case selection are SPEQ practitioner synthesis.

MAPPED STANDARDS
EU GVP ModulesReg. (EU) 520/2012
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