Chapter 6

Establishing a Pharmacovigilance Quality Control (PQC) System

The Pharmacovigilance System Master File (PSMF)

PSMF

The "central nervous system" of the safety infrastructure

Legally required under GVP Module I

1

Qualified Person (QPPV)

Summary CV, contact details, and deputising arrangements

2

Organizational Structure

Hierarchy and location of all pharmacovigilance activities

3

Sources of Safety Data

Description of spontaneous, clinical trial, and literature monitoring sources

4

Computerized Systems

Details on the safety database, IT infrastructure, and validation status

5

PV Processes

Standard Operating Procedures (SOPs) governing all safety activities

6

System Performance

KPIs such as reporting compliance rates and data quality metrics

7

Quality System

Details on internal audits, regulatory inspections, and Corrective Action / Preventive Action (CAPA) plans

The Qualified Person for Pharmacovigilance (QPPV)

👨‍⚖️

Personal & Legal Accountability

In the EU, the QPPV is personally and legally accountable for the pharmacovigilance system's performance. Must reside and operate within the EU/EEA.

Available 24/7 to respond to queries from health authorities.

System oversight Signal escalation Regulatory liaison Risk communication PSMF maintenance

Quality Cycle — Plan, Adhere, Control, Improve

Quality Planning Define SOPs, KPIs, standards Quality Adherence Execute per SOPs, training compliance Quality Control Audits, inspections, monitoring Quality Improvement CAPA, process optimization GVP Module I ⟳ ⟳ ⟳ ⟳

Audit vs. Inspection

Internal Audit

Conducted by: Company's quality department
Nature: Systematic, independent examination
Purpose: Verify internal compliance with SOPs and GVP
Frequency: Scheduled per risk-based audit plan
Outcome: Internal findings → CAPA implementation

Regulatory Inspection

Conducted by: Health authorities (FDA, EMA, etc.)
Nature: Official regulatory review
Purpose: Ensure legal compliance and public health protection
Frequency: Risk-based; may be triggered by safety concerns
Outcome: Findings may lead to regulatory action or sanctions

CAPA Process — Corrective and Preventive Action

Identify Deficiency
e.g., Late reporting, incomplete coding
→
Root Cause Analysis
Determine systemic vs. individual causes
→
Corrective Action
Fix the immediate problem
→
Preventive Action
Systemic change to prevent recurrence
→
Verify Effectiveness
Monitor KPIs to confirm the fix works

CAPA Is More Than a Fix

A CAPA is a documented, systemic change to the pharmacovigilance process. It includes root cause analysis, corrective action (fixing the immediate problem), and preventive action (ensuring it does not recur). Both components are required by regulators during inspections.

Pharmacovigilance Manual — Causality Assessment & Signal Detection · Chapter 6