GVP — Good Pharmacovigilance Practice
Stress-Testing Your Drug Safety Monitoring & Signal Detection Systems
Pharmacovigilance is a non-negotiable lifecycle requirement to ensure the ongoing safety of medicinal products. Arirex provides specialized technical audits of your Pharmacovigilance System Master File (PSMF), signal management processes, and safety reporting workflows to ensure total compliance with EMA GVP Modules and FDA Postmarketing Safety Reporting requirements.
Core Technical Audit Focus
PSMF & QPPV Oversight
- Pharmacovigilance System Master File: Technical review of the PSMF structure and annexes (Module II) to ensure they accurately reflect the global safety system and quality oversight.
- QPPV Accountability: Verification of the Qualified Person for Pharmacovigilance (QPPV) oversight, 24/7 availability, and deputy arrangements.
- Subcontractor Oversight: Auditing of PV Service Providers and Safety Data Exchange Agreements (SDEAs) to ensure clear accountability for safety reporting lines.
Signal Management & Reporting
- Signal Detection Process: Technical assessment of signal detection methodologies, prioritization, and safety profile evaluations (Module IX).
- ICSR & Periodic Reporting: Auditing of Individual Case Safety Reports (ICSR) processing, expedited reporting timelines, and the quality of Periodic Safety Update Reports (PSUR/PBRER).
- Risk Management Plans (RMP): Verification of risk minimization implementation and the effectiveness of safety communication strategies.
Regulatory Standards & References
- EMA: Good Pharmacovigilance Practices (GVP) Modules I–XVI.
- FDA: 21 CFR 314.80 (Postmarketing reporting) and Guidance on Signal Management.
- ICH: E2C (Periodic Reporting), E2E (Pharmacovigilance Planning), and E2F (Development Safety Update Reports).
- Global: Local health authority requirements for MAH (Marketing Authorization Holder) safety obligations.
The ARIREX GVP Deliverable
We don't just find gaps; we stress-test the agility of your safety system. Every GVP audit results in a regulatory-mapped report that identifies "blind spots" in signal monitoring and provides a clear remediation pathway to protect both patients and your brand integrity.