Driving Global Pharmacovigilance Audit Compliance for a Global Pharmaceutical Leader

Driving Global Pharmacovigilance Audit Compliance for a Global Pharmaceutical Leader: Case Study Overview

Pharmacovigilance (PV) audits are critical for ensuring regulatory compliance, patient safety, and the integrity of PV systems. Regulatory guidelines, including EMA- Good pharmacovigilance practices (GVP), ICH E2E, and US FDA PV regulations, mandate periodic, risk-based audits of PV systems, business partners, affiliates, and service providers. A comprehensive PV audit framework is essential for organisations to achieve sustainable compliance and regulatory confidence across global operations.

Case Study Highlights

A leading global pharmaceutical company headquartered in the Netherlands, with a therapeutic portfolio spanning anaesthetics, psychiatry, urology, paediatrics, and infectious diseases, sought support for its PV audit programme.

Their specific challenges included:

• Non-compliance with regulatory requirements for periodic PV audits of partners and vendors
• Lack of a robust, risk-based audit framework and limited Quality Assurance (QA) resources
• Need for a sustainable global audit programme to meet regulatory standards

The company’s EU Qualified Person for Pharmacovigilance (QPPV) engaged APCER to design and execute a comprehensive audit programme. Within just 1.5 years, APCER successfully conducted 20 PV audits of partners, affiliates, service providers, and systems, achieving 100% compliance with the tactical audit plan and strengthening the client’s PV oversight.

The QPPV and the client’s team provided excellent feedback on APCER’s audit rigour and the quality of reporting. What began as a targeted engagement has evolved into a long-term strategic partnership.

How APCER’s QA Team Helped:

APCER’s team delivered the results through a structured approach:

• Risk-Based Planning: Conducted a detailed preliminary assessment and prioritised audits based on compliance risk and business criticality
• Audit Execution: Conducted robust audits of vendors, systems, and partners by deploying experienced auditors to ensure adherence to global PV standards
• Ongoing Audit Programme: Implemented a sustainable, risk-based PV audit programme

APCER’s QA Capabilities

• 500+ GVP audits conducted by a well-trained, experienced QA team
• Audits conducted across multiple regions, such as the US, the EU, the UK, and Asia, covering various therapeutic areas, including biologics
• End-to-end Quality Management System (QMS) services, including CAPA, deviation management, and SOP management
• Supported and participated in 100+ regulatory inspections, including those conducted by the US FDA, the UK MHRA, and the EMA