What You Need to Know for Global Compliance
In the interconnected pharmaceutical landscape, companies are not only expected to maintain local compliance but also to meet global regulatory expectations consistently across regions. This is where regulatory pharmacovigilance audits come into sharp focus. Whether it’s the EMA, MHRA, FDA, or other global health authorities, expectations are rising, and so is the scrutiny on pharmacovigilance systems.
So, what exactly do these audits involve, and how can you ensure your organisation is globally compliant and inspection-ready?
What Are Regulatory Pharmacovigilance Audits?
Regulatory pharmacovigilance audits are formal assessments, either internal or external, designed to evaluate whether a company’s PV system complies with applicable laws, guidelines, and Good Pharmacovigilance Practices (GVP). Unlike routine internal audits, these are typically performed to satisfy regulatory authority expectations or prepare for inspection.
They assess how well your safety systems operate—from adverse event collection and risk management to signal detection, quality assurance, and vendor oversight.
Why Global Compliance Is Critical
Global health authorities each have their regulations, but the core principles of patient safety, data integrity, and transparency remain consistent. A lapse in one country could lead to questions—or even penalties—across your global operations.
A globally aligned pharmacovigilance system should:
- Meet the requirements of all relevant health authorities (EMA, MHRA, FDA, TGA, etc.)
- Maintain consistent documentation, regardless of region
- Harmonise SOPs and training across global affiliates
- Be prepared for both planned and unannounced inspections
This is why global inspection support and a robust PV audit programme are essential parts of any pharmacovigilance strategy.
What to Expect in a Regulatory PV Audit
Regulators may assess:
- The structure and oversight of the pharmacovigilance system
- Compliance with expedited reporting timelines (ICSRs, PSURs, etc.)
- Risk management plans and implementation of risk minimisation measures
- Vendor and affiliate oversight processes
- Training records and role-specific qualifications
- CAPA implementation and tracking from prior audits or inspections
How to Prepare for Global Regulatory Scrutiny
- Conduct regular internal audits that simulate regulatory inspections
- Standardise documentation and maintain real-time access to key records
- Align global affiliate processes with corporate compliance standards
- Train staff continually on evolving global regulations
- Track and trend audit findings to identify systemic gaps
How Q&V Can Help You Stay Globally Compliant
At Q&V, we support life sciences organisations with proactive, end-to-end solutions for regulatory pharmacovigilance audits. Our expertise spans global requirements, and we offer tailored global inspection support to help your teams not only prepare for audits but succeed in them.
From conducting readiness assessments and mock inspections to managing CAPAs and aligning affiliate operations, Q&V’s team of audit experts is here to guide you every step of the way.