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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

Pharmaceuticals

Standard

Good Pharmacovigilance Practices (GVP) Module VII

Workspaces

Pharmaceutical company offices
Pharmacovigilance departments
Regulatory affairs departments

Occupations

Pharmacovigilance Auditor
PSUR Writer
Safety Physician
Regulatory Affairs Specialist
Pharmacovigilance Data Analyst

PSUR Processes Audit

(0 / 7)

1
When is the next scheduled audit for the PSUR process?

Select the date for the next audit.

To plan for future audits and ensure regular oversight.
2
Has training on PSUR processes been completed by all relevant staff?

Indicate whether training has been completed.

To ensure staff are adequately trained on compliance requirements.
3
What is the status of recommendations from the last audit?

Select the action status.

To track the implementation of previous audit recommendations.
4
Provide a summary of the findings from the audit.

Summarize your findings in detail.

To capture qualitative insights from the audit.
Write something awesome...
5
How many Periodic Safety Update Reports were submitted in the last year?

Enter the total number of PSURs.

To evaluate the volume of safety reporting.
Min: 0
Max: 1000
6
Is the PSUR process compliant with GVP Module VII?

Select the compliance status.

To assess adherence to regulatory standards.
7
What is the date of the audit?

Enter the date in YYYY-MM-DD format.

To document the timing of the audit for future reference.
8
Is a follow-up audit required?

Select whether a follow-up is required.

To determine if additional oversight is necessary.
9
When was the audit report submitted?

Select the submission date of the audit report.

To keep track of report timelines and ensure compliance.
10
What are the detailed recommendations for improvement?

Detail your recommendations for process improvements.

To provide actionable insights based on the audit findings.
Write something awesome...
11
What level of risk was identified during the audit?

Select the risk level identified.

To categorize the risk associated with the PSUR process.
12
On a scale of 1 to 5, how would you rate the quality of the PSUR documentation?

Select a rating from 1 (Very Poor) to 5 (Excellent).

To quantitatively assess the quality of submitted PSURs.
Min: 1
Max: 5
13
Who conducted the audit?

Enter the full name of the auditor.

To identify the auditor responsible for the assessment.
14
What is the status of the action plan for identified issues?

Select the current status of the action plan.

To monitor the implementation of corrective actions.
15
Summarize feedback received from stakeholders regarding PSURs.

Provide a summary of stakeholder feedback.

To capture insights and opinions from relevant stakeholders.
Write something awesome...
16
How many safety signals were identified in the last PSUR?

Enter the total number of safety signals identified.

To track the number of safety signals reported for evaluation.
Min: 0
Max: 500
17
Did the organization adhere to PSUR reporting timelines?

Select adherence status.

To evaluate compliance with regulatory submission deadlines.
18
What was the date of the last submitted PSUR?

Select the date of the last PSUR submission.

To assess the timeliness of safety reporting.
19
What is the scope of the audit?

Describe the scope of the audit.

To define the boundaries and focus areas of the audit.
20
What is the status of follow-up on the risk management action plan?

Select the current status of the action plan follow-up.

To ensure continuous monitoring and improvement of risk management.
21
Provide a summary of key risk factors identified during the audit.

Summarize the key risk factors identified.

To document critical risks that may impact PSUR processes.
Write something awesome...
22
Is the organization compliant with the established risk management plan?

Select the compliance status.

To assess adherence to internal risk management protocols.
23
How many risk mitigation actions have been implemented since the last audit?

Enter the total number of implemented risk mitigation actions.

To evaluate the effectiveness of risk management strategies.
Min: 0
Max: 100
24
When was the most recent risk assessment conducted?

Select the date of the last risk assessment.

To ensure that risk assessments are current and relevant.
25
What is the primary objective of this audit?

Describe the main objective of the audit.

To clarify the main goals and intentions behind the audit.
26
What is the status of implementing audit recommendations?

Select the current implementation status.

To track the progress of corrective actions taken post-audit.
27
What lessons were learned from the audit process?

Describe the lessons learned during the audit.

To capture insights that can improve future audits.
Write something awesome...
28
How many findings were identified during the audit?

Enter the total number of findings.

To quantify the issues discovered during the audit.
Min: 0
Max: 100
29
How effective was the audit process in identifying issues?

Select the effectiveness rating.

To evaluate the performance and thoroughness of the audit.
30
What is the completion date of the audit?

Select the date when the audit was completed.

To document when the audit was finalized.
31
Who are the members of the audit team?

List the names of the audit team members.

To identify the individuals involved in the audit process.

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