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.
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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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