Pharmaceutical Pharmacovigilance System Audit Checklist

A comprehensive audit checklist for evaluating pharmaceutical pharmacovigilance systems, ensuring regulatory compliance, and maintaining the highest standards in drug safety monitoring and risk management practices.

Pharmaceutical Pharmacovigilance System Audit Checklist
by: audit-now
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About This Checklist

Pharmacovigilance is a critical function in the pharmaceutical industry, focusing on the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problems. This Pharmacovigilance System Audit Checklist is designed to comprehensively evaluate the effectiveness and compliance of pharmacovigilance processes within pharmaceutical organizations. By systematically assessing adverse event reporting, signal detection, risk management, safety communications, and quality management systems, this checklist helps identify potential gaps in pharmacovigilance practices, ensures regulatory compliance, and ultimately contributes to patient safety and public health protection. Regular use of this checklist supports continuous improvement in drug safety monitoring and promotes a robust safety culture within the organization.

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Industry

Pharmaceuticals

Standard

EMA Good Pharmacovigilance Practices (GVP), FDA 21 CFR Part 314.80, ICH E2A-E2F

Workspaces

Pharmaceutical manufacturing plants

Occupations

Pharmacovigilance Managers
Drug Safety Officers
Medical Affairs Specialists
Regulatory Affairs Managers
Quality Assurance Auditors

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