PSMF Inspection Readiness Checklist

Introduction

Many organisations prepare their PSMF shortly before an inspection.

Mature organisations maintain their PSMF in an inspection-ready state continuously.

This distinction is important.

Inspection readiness is not a document condition.

It is a governance condition.

A PSMF can appear complete while containing significant weaknesses.

Conversely, a concise PSMF may demonstrate excellent control of the pharmacovigilance system.

The objective of this checklist is therefore not simply to assess document quality.

The objective is to assess whether the PSMF accurately represents a well-governed pharmacovigilance system.

The Core Inspection Question

Most inspection activities ultimately seek to answer three questions:

Does the organisation understand its pharmacovigilance system?

Does the organisation control its pharmacovigilance system?

Can it demonstrate that control?

Every item within this checklist supports one or more of these objectives.

Section 1: Governance Readiness

Ownership

Confirm:

• PSMF ownership is formally assigned.
• Responsibilities are documented.
• Annex owners are identified.
• Escalation pathways are defined.

Questions:

• Who owns the PSMF?
• Who owns each annex?
• Who approves significant updates?

Potential Red Flags:

• Shared ownership without accountability.
• Informal update processes.
• No defined governance structure.

Governance Reviews

Confirm:

• Reviews occur according to schedule.
• Review outcomes are documented.
• Significant issues are escalated.
• Actions are tracked to completion.

Potential Red Flags:

• Reviews consistently delayed.
• Missing evidence of review.
• Actions repeatedly overdue.

Section 2: QPPV Readiness

QPPV Information

Verify:

• Name is correct.
• Contact details are current.
• Location information is correct.
• Deputy arrangements are documented.

Questions:

• Could an inspector contact the QPPV immediately?
• Does information match regulatory records?

Potential Red Flags:

• Outdated contact details.
• Missing deputy information.
• Inconsistencies across documents.

QPPV Awareness

Confirm the QPPV can explain:

• Organisational structure.
• Vendor oversight model.
• Product scope.
• Governance arrangements.
• Major compliance risks.

Potential Red Flags:

• Limited familiarity with the PSMF.
• Inability to explain governance structures.
• Unclear oversight responsibilities.

Section 3: Product Inventory Readiness

Product Scope

Verify:

• All products are included.
• Marketing status is current.
• Acquired products are incorporated.
• Divested products are removed appropriately.

Questions:

• Does the inventory reflect actual responsibility?

Potential Red Flags:

• Missing products.
• Legacy products retained incorrectly.
• Delayed updates after acquisitions.

Reconciliation

Confirm:

• Product inventories are periodically verified.
• Discrepancies are investigated.
• Evidence of review exists.

Potential Red Flags:

• No reconciliation process.
• Repeated discrepancies.

Section 4: Vendor Readiness

Vendor Inventory

Verify:

• All PV vendors are listed.
• Activities are accurately described.
• Critical vendors are identifiable.
• Oversight owners are assigned.

Questions:

• Can every outsourced activity be linked to a vendor?

Potential Red Flags:

• Missing vendors.
• Unclear responsibilities.
• Inconsistent inventories.

Oversight Evidence

Confirm:

• Vendor oversight activities occur.
• Reviews are documented.
• Performance is monitored.
• Significant issues are escalated.

Potential Red Flags:

• Oversight described but not evidenced.
• Missing governance records.

Section 5: Organisational Structure Readiness

Verify:

• Reporting lines are current.
• Key roles are represented.
• Affiliate structures are accurate.
• Governance committees are reflected correctly.

Questions:

• Does the organisational chart match operational reality?

Potential Red Flags:

• Former functions still listed.
• Incorrect reporting structures.
• Missing affiliates.

Section 6: System Inventory Readiness

Verify:

• Safety databases are listed.
• Reporting platforms are listed.
• Signal management systems are listed.
• Retired systems have been removed.

Questions:

• Can all major PV systems be identified quickly?

Potential Red Flags:

• Obsolete systems.
• Missing critical platforms.
• Inconsistent descriptions.

Section 7: Annex Readiness

Annex Completeness

Verify:

• Required annexes exist.
• Annexes are accessible.
• Annexes are version controlled.

Potential Red Flags:

• Missing annexes.
• Unclear ownership.
• Inconsistent formats.

Annex Accuracy

Verify:

• Information remains current.
• Inventories align with reality.
• Recent changes are reflected.

Potential Red Flags:

• Stale information.
• Missing updates.
• Contradictions between annexes.

For additional guidance see:

[[psmf-annexes-guide]]

Section 8: Change Control Readiness

Verify:

• Significant changes trigger review.
• PSMF impact assessments occur.
• Updates are documented.
• Approvals are retained.

Questions:

• How are changes identified?
• How are updates triggered?

Potential Red Flags:

• Informal update processes.
• No documented change assessment.

For additional guidance see:

[[psmf-maintenance-and-change-control]]

Section 9: Audit and CAPA Readiness

Audit Programme

Verify:

• Planned audits occur.
• Audit schedules are current.
• Findings are tracked.

Potential Red Flags:

• Delayed audits.
• Missing audit records.

CAPAs

Verify:

• CAPAs remain current.
• Overdue actions are visible.
• Effectiveness checks occur.

Potential Red Flags:

• Repeated findings.
• Long-overdue CAPAs.
• Weak root cause analysis.

Section 10: Inspection Readiness Assessment

Ask the following questions.

Accuracy

Does the PSMF accurately reflect the current system?

Completeness

Is all required information available?

Traceability

Can information be verified quickly?

Governance

Are oversight activities documented?

Sustainability

Would the PSMF remain accurate if inspected tomorrow?

A "no" answer to any of these questions should trigger review.

A Simple Readiness Scoring Model

Some organisations find scoring useful.

Example:

Interpretation:

The scoring model is less important than the discussions it generates.

What Mature Organisations Do Differently

High-performing organisations:

• Review continuously.
• Integrate governance and maintenance.
• Assign ownership clearly.
• Monitor metrics.
• Treat inspection readiness as a daily activity.

Importantly, they rarely conduct large remediation projects immediately before inspections.

Their systems remain inspection-ready throughout the year.

Key Takeaways

• Inspection readiness reflects governance quality rather than document quality alone.
• Product inventories and vendor inventories are common risk areas.
• QPPV awareness remains a critical inspection consideration.
• Annexes require continuous maintenance.
• Change control is essential for long-term accuracy.
• Audits and CAPAs provide evidence of system effectiveness.
• Mature organisations maintain readiness continuously rather than preparing only before inspections.

References

1. EMA Good Pharmacovigilance Practices (GVP) Module II – Pharmacovigilance System Master File.
2. EMA Good Pharmacovigilance Practices (GVP) Module III – Pharmacovigilance Inspections.
3. EMA Good Pharmacovigilance Practices (GVP) Module I – Pharmacovigilance Systems and Their Quality Systems.
4. Regulation (EC) No 726/2004.
5. Directive 2001/83/EC.
6. Commission Implementing Regulation (EU) No 520/2012.
7. EMA Questions and Answers on Pharmacovigilance System Master Files.