2- Good Pharmacovigilance Practices (GVP)

Qual-Med Yemen delivers internationally aligned GVP auditing services designed to evaluate and strengthen the pharmacovigilance systems of local pharmaceutical suppliers. Our independent audits verify compliance with both global partner requirements and current regulatory standards (e.g., ICH, EU GVP, and local regulations), empowering global pharmaceutical stakeholders with confidence in their local partners’ ability to meet operational and regulatory demands.
Our GVP Audit Approach: As a seamless on-the-ground extension of your pharmacovigilance auditing team, Qual-Med Yemen conducts audits tailored to your strategic priorities. We adapt to your preferred framework—leveraging your established audit program or Qual-Med Yemen process—to ensure your local partners maintain robust, effective local pharmacovigilance systems. Our audits evaluate a wide range of Pharmacovigilance activities, with a focus on these core pillars:

Pillar	Description
Pillar A: Quality Management System	Quality Management System: Includes written procedures (SOPs, work instructions, forms), monthly reporting, internal/external audits, CAPA management, archiving, and record retention. Document and IT Systems Review: Encompasses document review and management of IT systems, including business continuity and disaster recovery plans.
Pillar B: Training and Human Resources	Organizational Structure and Resource Management: Covers personnel training (including database training), job descriptions, and CV management. Local Qualified/Responsible Person for Pharmacovigilance (QPPV): Involves qualifications, job descriptions, oversight of the pharmacovigilance system, file management, and liaison with competent authorities.
Pillar C: Pharmacovigilance and Signal Management	Individual Case Safety Report (ICSR) Management: Involves collection of adverse events (including product quality complaints and medical inquiries), quality checks, translation, reporting, tracking, and follow-up processes. Local Literature, Website & Social Media Screening: Involves gathering adverse event data from local scientific journals and online platforms, with quality checking, translation, and reconciliation. Signal and Risk Management: Includes signal monitoring and tracking, information exchange, reporting to authorities, submission of risk management plans (RMPs), and implementation of risk minimization measures (RMMs).
Pillar D: Regulatory Affairs and Compliance	Regulatory Affairs & Intelligence: Covers submission of product labeling variations, monitoring and managing local and international regulatory requirements, and handling regulatory authority requests. Periodic Reporting and Ongoing Safety Monitoring: Involves providing data to relevant stakeholders, managing periodic report submissions, and addressing emerging safety signals.

Good Pharmacovigilance Practices (GVP)

Assessing Your Local Partner GVP System

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