Pharmacovigilance System Master File (PSMF)
📘 Pharmacovigilance System Master File (PSMF)
✅ What is PSMF?
The Pharmacovigilance System Master File (PSMF) is a legal, detailed, and continuously maintained document that describes the pharmacovigilance (PV) system used by a Marketing Authorization Holder (MAH).
📌 Purpose of the PSMF
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Demonstrates compliance with pharmacovigilance obligations.
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Serves as a primary reference during PV inspections.
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Provides a transparent overview of the PV system structure, processes, and performance.
🏛️ Regulatory Basis
| Region | Regulatory Source |
|---|---|
| EU | GVP Module II |
| UK | MHRA Guidance on PSMF |
| US | Not mandatory, but similar content may be required during inspections |
| ICH | Refers indirectly via PV system documentation (e.g., E2E) |
🧩 Key Components of PSMF (per GVP Module II)
| Section | Contents |
|---|---|
| 1. QPPV Details | Name, qualifications, contact information of the EU QPPV |
| 2. MAH Information | Legal entity details, sites covered by the PV system |
| 3. PV System Description | Overview of the system, organization chart, responsibilities |
| 4. Sources of Safety Data | Data collected from clinical trials, post-marketing, literature, etc. |
| 5. Computerized Systems | Safety database(s), IT tools, signal detection software |
| 6. PV Processes | ICSR reporting, signal detection, risk management, PBRER, etc. |
| 7. Quality System | SOPs, training, audits, CAPAs |
| 8. Performance Indicators | KPIs used to measure the effectiveness of PV activities |
| 9. Affiliate/Partner Oversight | Contracts, PV agreements (PVAs), vendor oversight |
| Annexes | SOP list, product list, training records, CV of QPPV, audit plans, etc. |
🗂️ PSMF Characteristics
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Must be readily available within the EU (or UK if applicable).
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Maintained continuously, updated at least every quarter.
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Must be accessible within 7 calendar days during inspections.
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Can be in electronic or paper format.
🔐 Responsibilities
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QPPV has overall responsibility for maintaining and ensuring PSMF accuracy.
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MAH must ensure that local affiliates, partners, and third parties follow the documented PV system.
🔍 Inspection Readiness
During PV inspections, authorities will review the PSMF to:
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Confirm PV structure and QPPV responsibilities.
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Verify the accuracy of SOPs and records.
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Review CAPA implementation and training compliance.
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Assess signal detection, database access, and global reporting systems.
🧠 Summary for Interviews or Exams
| Aspect | Detail |
|---|---|
| Legal Basis | GVP Module II |
| Owner | Marketing Authorization Holder |
| Maintained by | QPPV |
| Location | Accessible in EU (or UK) |
| Purpose | Describe PV system, support inspections |
| Update Frequency | Ongoing, at least quarterly |
| Contents | QPPV info, system processes, SOPs, KPIs, training, CAPAs |
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