In today’s stringent regulatory landscape, the effectiveness of a pharmaceutical company’s pharmacovigilance (PV) system is supported by three key pillars: the Qualified Person for Pharmacovigilance (QPPV), the Local Person for Pharmacovigilance (LPPV), and the Pharmacovigilance System Master File (PSMF). For Marketing Authorization Holders (MAHs), understanding the interaction between these components is vital to ensure compliance, patient safety, and seamless operation across global markets.
The Role of the QPPV: Central Leadership in PV Oversight
Under EU legislation, every MAH must designate a Qualified Person Responsible for Pharmacovigilance (QPPV). The QPPV is ultimately accountable for the MAH’s pharmacovigilance system and must reside and operate in the European Economic Area (EEA).
Key Responsibilities of the QPPV:
- Oversight and governance of the entire PV system.
- Ensuring continuous availability and proper functioning of the PV system.
- Acting as the primary PV contact person for the competent authorities of EU member states and European Medicines Agency (EMA) on a 24-hour basis and for PV inspections.
- Maintaining up-to-date overview on the safety profile of all products under the MAH.
- Playing a key role in risk management planning and post-market safety evaluation.
The QPPV is also responsible for maintaining the PSMF, which serves as a centralized, structured record of the MAH’s PV system.
The LPPV Network: Local Compliance in a Global Framework
While the QPPV ensures centralized oversight, local regulations often require a National Contact Person for Pharmacovigilance or a Local Person for Pharmacovigilance (LPPV) in specific countries. These roles ensure that country-specific pharmacovigilance obligations are met in line with national laws and health authority expectations.
LPPV Responsibilities Typically Include:
- Acting as the local contact person for the National Competent Authority (NCA).
- Monitoring local regulatory changes
- Supporting inspections and audits at the local level.
- Contributing to local Risk Minimisation activities and Product Information updates.
A number of countries, such as France, Germany, Italy, and Czech Republic, have detailed requirements for LPPV roles, including residency, language proficiency, and direct accountability.
For MAHs, managing a network of LPPVs across different territories is essential to ensure compliance to local regulatory expectations which provides additional value to the centralized QPPV oversight.
The Pharmacovigilance System Master File (PSMF): Documenting the Entire PV System
The PSMF is a legally required document that provides a comprehensive overview of the MAH’s PV system. It is under the ownership of the QPPV and is often scrutinized during inspections.
Key Elements of the PSMF Include:
- An overview of the PV system’s structure, including the QPPV and LPPV roles.
- Organizational charts and affiliations of involved personnel.
- Description of data sources, safety database management, and reporting mechanisms.
- Audit outcomes, CAPAs, and training programs.
- A list of all products covered by the PV system.
The PSMF must be kept current and should reflect the actual state of the PV system at all times. It is typically stored at the main site of the PV system or at a location of the QPPV.
To learn more, watch our webinar: How to Setup an Effective PV System in the UK and EU/EEA
MAH Best Practices for Coordinating QPPV, LPPV, and the PSMF
- Clear Role Definitions and Documentation: Ensure that the responsibilities of QPPVs and LPPVs are clearly documented in the PSMF and internal SOPs.
- Regular Communication: Establish formal communication channels between the QPPV and LPPVs for updates on safety concerns, regulatory changes, and local deviations.
- Training and Qualification: Maintain robust onboarding and ongoing training for all PV personnel, tailored to local and global requirements.
- PSMF Maintenance: Develop procedures for timely updates and version control of the PSMF, ensuring accuracy in case of inspections.
- Inspection Readiness: Conduct regular internal audits and mock inspections to ensure alignment of global and local PV practices.
Conclusion
For MAHs, the interplay between the QPPV, LPPV, and PSMF forms the backbone of a compliant and efficient pharmacovigilance system. A strong central PV strategy led by the QPPV, supported by knowledgeable and responsive LPPVs, and documented through a well-maintained PSMF, is critical to regulatory success and, most importantly, to safeguarding patient health worldwide.
