What is a QPPV Inspection?
A pharmacovigilance inspection is a regulatory assessment used to evaluate whether a marketing authorisation holder operates an effective and compliant pharmacovigilance system.
Purpose of a Pharmacovigilance Inspection
Regulatory authorities conduct inspections to determine whether pharmacovigilance activities are performed in accordance with applicable legislation, guidance and company procedures.
Inspections are intended to verify that patient safety is adequately protected and that organisations maintain effective systems for monitoring medicinal product safety.
Why the QPPV is Important During Inspections
The QPPV occupies a central position within the pharmacovigilance system and is often interviewed during inspections.
- How the QPPV maintains oversight
- How compliance risks are identified
- How issues are escalated
- How governance processes operate
- How outsourced activities are managed
- How the QPPV remains informed of system performance
Inspection Triggers
- New marketing authorisations
- Organisational changes
- Previous inspection findings
- Safety concerns
- Significant compliance issues
- Major outsourcing activities
Common Areas Reviewed
- QPPV oversight arrangements
- PSMF accuracy
- Case processing compliance
- Signal management activities
- Risk management systems
- Vendor oversight
- Computerised systems
- Training records
- CAPA management
- Governance processes
Preparing for an Inspection
Inspection readiness should be maintained continuously rather than initiated only after inspection notification.
Effective preparation often includes PSMF reviews, mock inspections, compliance monitoring, CAPA reviews, vendor oversight assessments and governance reviews.
Practical Perspective
The most successful inspections generally occur when inspection readiness is embedded within normal business operations.
Last reviewed: June 2026