In an increasingly regulated pharmaceutical landscape, pharmacovigilance audit services have become essential for ensuring that drug safety systems are both compliant and effective. Whether driven by internal quality assurance needs or regulatory expectations, pharmacovigilance audits help safeguard patient safety and ensure that organisations remain inspection-ready at all times.
If you’ve ever wondered what these services involve and why they’re so important, this blog will give you a clear and practical overview.
What Are Pharmacovigilance Audit Services?
Pharmacovigilance audit services involve the independent, systematic assessment of an organisation’s pharmacovigilance system. These audits evaluate how well an organisation collects, manages, and reports safety data and whether it adheres to applicable regulatory frameworks such as Good Pharmacovigilance Practice (GVP), ICH E2E, and country-specific requirements (e.g., MHRA or FDA).
Organisations typically engage a PV audit expert to conduct these audits internally or externally, depending on their needs and structure.
What to Expect from a PV Audit
A comprehensive pharmacovigilance audit usually covers the following:
1. Pre-Audit Planning
- Defining the audit scope, objectives, and methodology
- Reviewing previous audit findings and CAPAs
- Identifying key stakeholders and PV activities to be assessed
2. On-Site or Remote Audit Activities
- Reviewing SOPs, processes, and systems (e.g., safety databases)
- Conducting interviews with relevant staff
- Examining training records, quality documentation, and compliance metrics
3. Audit Reporting
- Documenting observations (critical, major, minor)
- Providing detailed recommendations for improvement
- Issuing a formal audit report
4. Follow-Up and CAPA Management
- Supporting the organisation in addressing findings
- Ensuring effective and sustainable corrective actions are implemented
Why Pharmacovigilance Audits Matter
These audits are not simply about ticking regulatory boxes—they offer substantial value to your organisation:
- Ensure regulatory compliance and inspection readiness
- Identify gaps and areas of risk before regulators do
- Strengthen pharmacovigilance quality assurance
- Support better operational efficiency and accountability
- Demonstrate a commitment to patient safety and product integrity
Whether you’re launching a new product, managing global operations, or overseeing vendors, PV audits play a crucial role in safeguarding your compliance framework.
How Q&V Can Support Your Audit Needs
At Q&V, we provide tailored pharmacovigilance audit services designed to help you meet regulatory expectations with clarity and confidence. Our experienced PV audit experts conduct risk-based, GVP-aligned audits that give you real insights—not just findings. From internal audits and vendor assessments to full system reviews and inspection readiness planning, we offer flexible support to suit your organisation’s size, structure, and strategic goals.