GVP Module VIII - Post-Authorization Safety Studies (PASS) Audit Checklist
A comprehensive checklist for auditing the design, conduct, and reporting of post-authorization safety studies in compliance with GVP Module VIII requirements.
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About This Checklist
The GVP Module VIII Post-Authorization Safety Studies (PASS) Audit Checklist is an essential tool for evaluating the design, conduct, and reporting of post-authorization safety studies in the pharmaceutical industry. This comprehensive checklist assists auditors and pharmacovigilance professionals in assessing compliance with regulatory requirements and scientific standards for PASS. By systematically reviewing key elements of PASS processes, this checklist helps ensure the quality and integrity of safety data, supports regulatory compliance, and ultimately contributes to a better understanding of the safety profile of medicinal products in real-world settings.
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