GVP Module VII - Periodic Safety Update Report (PSUR) Audit Checklist
A comprehensive checklist for auditing the preparation and submission of Periodic Safety Update Reports (PSURs) in compliance with GVP Module VII requirements.
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About This Checklist
The GVP Module VII Periodic Safety Update Report (PSUR) Audit Checklist is an indispensable tool for evaluating the preparation and submission of PSURs in the pharmaceutical industry. This comprehensive checklist assists auditors and pharmacovigilance professionals in assessing the quality, completeness, and timeliness of PSURs. By systematically reviewing key elements of PSUR processes, this checklist helps ensure regulatory compliance, supports the ongoing evaluation of a product's benefit-risk profile, and ultimately contributes to maintaining patient safety throughout a medicinal product's lifecycle.
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