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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Enter the full name of the auditor.
Select a rating from 1 (Very Poor) to 5 (Excellent).
Select the risk level identified.
Detail your recommendations for process improvements.
Select the submission date of the audit report.
Select whether a follow-up is required.
Describe the scope of the audit.
Select the date of the last PSUR submission.
Select adherence status.
Enter the total number of safety signals identified.
Provide a summary of stakeholder feedback.
Select the current status of the action plan.
Describe the main objective of the audit.
Select the date of the last risk assessment.
Enter the total number of implemented risk mitigation actions.
Select the compliance status.
Summarize the key risk factors identified.
Select the current status of the action plan follow-up.
List the names of the audit team members.
Select the date when the audit was completed.
Select the effectiveness rating.
Enter the total number of findings.
Describe the lessons learned during the audit.
Select the current implementation status.
FAQs
The primary objective is to assess the quality, completeness, and timeliness of Periodic Safety Update Reports (PSURs) in accordance with GVP Module VII requirements.
By ensuring thorough and accurate PSURs, the checklist helps in the ongoing evaluation of a product's benefit-risk profile, facilitating timely detection and communication of important safety information.
Audits should involve pharmacovigilance auditors, PSUR writers, safety physicians, regulatory affairs professionals, and data analysts responsible for PSUR preparation and submission.
The checklist covers areas such as data collection and analysis, benefit-risk evaluation, signal detection, literature review, safety communication, and adherence to PSUR submission timelines.
PSUR process audits should be conducted periodically, typically annually, or more frequently if significant changes occur in the pharmacovigilance system or regulatory requirements for PSURs.
Benefits
Ensures comprehensive evaluation of PSUR preparation and submission processes
Facilitates compliance with GVP Module VII requirements and other applicable regulations
Helps identify gaps in data collection, analysis, and reporting for PSURs
Supports the generation of high-quality, informative periodic safety reports
Enhances the ability to detect and communicate important safety information in a timely manner