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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.

GVP Module VII - Periodic Safety Update Report (PSUR) Audit Checklist

by: audit-now
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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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Industry

Healthcare

Standard

Pharmacovigilance Standards

Workspaces

Pharmacovigilance departments
Pharmaceutical Offices
Office Buildings

Occupations

Pharmacovigilance Auditor
PSUR Writer
Safety Physician
Regulatory Affairs Specialist
Pharmacovigilance Data Analyst
1
What is the date of the audit?
2
Is the PSUR process compliant with GVP Module VII?
3
How many Periodic Safety Update Reports were submitted in the last year?
Min: 0
Max: 1000
4
Provide a summary of the findings from the audit.
5
What is the status of recommendations from the last audit?
6
Has training on PSUR processes been completed by all relevant staff?
7
When is the next scheduled audit for the PSUR process?
8
Who conducted the audit?
9
On a scale of 1 to 5, how would you rate the quality of the PSUR documentation?
Min: 1
Max: 5
10
What level of risk was identified during the audit?
11
What are the detailed recommendations for improvement?
12
When was the audit report submitted?
13
Is a follow-up audit required?
14
What is the scope of the audit?
15
What was the date of the last submitted PSUR?
16
Did the organization adhere to PSUR reporting timelines?
17
How many safety signals were identified in the last PSUR?
Min: 0
Max: 500
18
Summarize feedback received from stakeholders regarding PSURs.
19
What is the status of the action plan for identified issues?
20
What is the primary objective of this audit?
21
When was the most recent risk assessment conducted?
22
How many risk mitigation actions have been implemented since the last audit?
Min: 0
Max: 100
23
Is the organization compliant with the established risk management plan?
24
Provide a summary of key risk factors identified during the audit.
25
What is the status of follow-up on the risk management action plan?
26
Who are the members of the audit team?
27
What is the completion date of the audit?
28
How effective was the audit process in identifying issues?
29
How many findings were identified during the audit?
Min: 0
Max: 100
30
What lessons were learned from the audit process?
31
What is the status of implementing audit recommendations?

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 of GVP Module VII - Periodic Safety Update Report (PSUR) Audit Checklist

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