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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FAQs
The primary focus is to assess the compliance and quality of post-authorization safety studies, including their design, conduct, and reporting, in accordance with GVP Module VIII requirements.
By ensuring rigorous PASS processes, the checklist helps generate reliable real-world safety data, contributing to a more comprehensive understanding of a product's safety profile post-authorization.
Audits should involve pharmacovigilance auditors, epidemiologists, clinical research professionals, medical affairs specialists, and regulatory affairs experts responsible for PASS activities.
The checklist covers areas such as study protocol development, ethical considerations, data collection methods, quality control processes, statistical analysis plans, and study reporting procedures.
PASS audits should be conducted at key milestones of individual studies, such as before study initiation, during data collection, and prior to final report submission, as well as periodically to assess overall PASS processes.
Benefits of GVP Module VIII - Post-Authorization Safety Studies (PASS) Audit Checklist
Ensures comprehensive evaluation of PASS design, conduct, and reporting
Facilitates compliance with GVP Module VIII requirements and other applicable regulations
Helps identify gaps in PASS processes and methodologies
Supports the generation of high-quality, reliable post-authorization safety data
Enhances the ability to make informed decisions about product safety in real-world use