GVP Audits

A pharmacovigilance system is only as strong as its weakest process — and regulators inspect it accordingly, often probing the seams between your organization and the partners and vendors who act on your behalf. PharmExpert's Good Pharmacovigilance Practices audits independently assess your PV system against the EU GVP Modules and applicable national requirements, covering your own organization and your affiliates, license partners and service providers.

We audit the elements inspectors focus on: the Pharmacovigilance System Master File (PSMF) and its accuracy, QPPV oversight and accountability, ICSR management and reporting timeliness, signal detection and management, risk-management plans, aggregate reporting, literature monitoring, and the CAPA and quality system that hold the whole system together. Each is tested against evidence and real performance, not just documented procedure.

Outsourced and partner activities deserve special attention because they are a frequent source of findings. A QPPV is accountable for the entire system, including work delegated to others, yet oversight of vendors and Safety Data Exchange Agreements is often where gaps hide. Our risk-based programs deliberately extend to PV service providers and license partners so the QPPV has documented assurance across the full system.

We can run a single targeted audit or design and execute a risk-based, multi-year PV audit program aligned to GVP Module IV. In every case you receive a referenced report with risk-ranked findings, a PSMF gap view where relevant, and practical CAPA direction — written to satisfy inspectors and to strengthen the system that protects patients.