Inspection Readiness
Inspection readiness is the ongoing state of preparedness that allows a pharmacovigilance system to demonstrate compliance with regulatory requirements during regulatory inspections.
The Role of the QPPV
The QPPV plays an important role in inspection readiness by maintaining oversight of the pharmacovigilance system and ensuring awareness of significant compliance risks.
Although operational activities may be delegated, the QPPV should understand how the pharmacovigilance system operates, the status of important compliance activities and the effectiveness of governance arrangements.
Key Components of Inspection Readiness
Governance
Effective governance supports inspection readiness through clear responsibilities, escalation pathways and oversight mechanisms.
Documentation
Documentation should accurately reflect how the pharmacovigilance system operates in practice.
Important documents commonly reviewed during inspections include the PSMF, SOPs, training records, quality system documentation and compliance reports.
Vendor Oversight
Marketing authorisation holders remain responsible for compliance even when activities are outsourced to service providers.
Training and Competency
Personnel performing pharmacovigilance activities should have appropriate training, experience and documented competencies.
Computerised Systems
Inspectors may review system validation, access controls, change management processes and business continuity arrangements.
Common Inspection Focus Areas
- Case processing compliance
- Signal management activities
- Risk management processes
- PSMF accuracy
- QPPV oversight
- Vendor oversight
- CAPA management
- Compliance monitoring activities
- Governance and escalation processes
Preparing for an Inspection
Inspection readiness should be maintained continuously rather than initiated only after inspection notification.
Practical activities commonly include periodic compliance reviews, internal audits, mock inspections, PSMF reviews, vendor oversight reviews and CAPA follow-up activities.
Relationship with the PSMF
The Pharmacovigilance System Master File (PSMF) is often used by inspectors as a starting point for understanding the pharmacovigilance system.
Maintaining an accurate and current PSMF is therefore an important component of inspection readiness.
Practical Perspective
Inspection readiness is not a project performed immediately before an inspection. It is the outcome of effective governance, quality systems, documentation management and ongoing oversight of pharmacovigilance activities.
Related Guides
Last reviewed: June 2026