GVP Pharmacovigilance System Master File (PSMF) Audit Checklist

A comprehensive checklist for auditing the Pharmacovigilance System Master File (PSMF) in accordance with Good Pharmacovigilance Practices (GVP) requirements.

GVP Pharmacovigilance System Master File (PSMF) Audit Checklist
by: audit-now
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About This Checklist

The GVP Pharmacovigilance System Master File (PSMF) Audit Checklist is an essential tool for ensuring compliance with Good Pharmacovigilance Practices (GVP) in the pharmaceutical industry. This comprehensive checklist helps auditors and quality assurance professionals systematically evaluate the completeness, accuracy, and effectiveness of a company's PSMF. By addressing key elements of pharmacovigilance systems, this checklist aids in identifying gaps, mitigating risks, and maintaining regulatory compliance, ultimately contributing to patient safety and product quality.

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Industry

Pharmaceuticals

Standard

Good Pharmacovigilance Practices (GVP)

Workspaces

Pharmaceutical company offices
Quality assurance departments
Regulatory affairs departments

Occupations

Pharmacovigilance Auditor
Quality Assurance Specialist
Regulatory Affairs Manager
Pharmacovigilance Officer
Compliance Manager

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