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GVP Pharmacovigilance System Master File (PSMF) Audit Checklist

A comprehensive checklist for auditing the Pharmacovigilance System Master File (PSMF) in accordance with Good Pharmacovigilance Practices (GVP) requirements.

GVP Pharmacovigilance System Master File (PSMF) Audit Checklist

by: audit-now
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About This Checklist

The GVP Pharmacovigilance System Master File (PSMF) Audit Checklist is an essential tool for ensuring compliance with Good Pharmacovigilance Practices (GVP) in the pharmaceutical industry. This comprehensive checklist helps auditors and quality assurance professionals systematically evaluate the completeness, accuracy, and effectiveness of a company's PSMF. By addressing key elements of pharmacovigilance systems, this checklist aids in identifying gaps, mitigating risks, and maintaining regulatory compliance, ultimately contributing to patient safety and product quality.

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Industry

Healthcare

Standard

Pharmacovigilance Standards

Workspaces

Pharmaceutical Offices
Quality Assurance Areas
Office Buildings

Occupations

Pharmacovigilance Auditor
Quality Assurance Specialist
Regulatory Affairs Manager
Pharmacovigilance Officer
Compliance Manager

1
Is the Pharmacovigilance System Master File (PSMF) compliant with GVP standards?

Select compliance status.

Ensures adherence to regulatory requirements.
2
What is the average time (in days) taken to report adverse events?

Enter the average reporting time in days.

Measures responsiveness in reporting.
Min: 0
Target: 3
Max: 30
3
How would you rate the training compliance of staff in pharmacovigilance?

Select the training compliance level.

Assesses staff preparedness and compliance.
4
Have all previous GVP audit findings been addressed?

Indicate whether all findings have been addressed.

Ensures continuous improvement and compliance.

5
What is the risk assessment level of the reported adverse events?

Select the risk assessment level.

Identifies the severity and necessary actions for reported events.
6
When was the last pharmacovigilance audit conducted?

Enter the date of the last audit.

Tracks audit frequency and ensures regular assessments.
7
What percentage of adverse event reports were submitted on time?

Enter the percentage of timely reports.

Evaluates the efficiency of the reporting process.
Min: 0
Target: 95
Max: 100
8
How satisfied are stakeholders with the current reporting process?

Select the satisfaction level.

Gauges stakeholder satisfaction for potential improvements.

9
How compliant is the organization with the established reporting guidelines?

Select the compliance level.

Ensures adherence to industry standards and regulations.
10
Is there an integrated feedback mechanism for reporting adverse events?

Indicate whether a feedback mechanism exists.

Assesses the ability to improve processes based on feedback.
11
What is the average time (in days) taken to resolve adverse event reports?

Enter the average resolution time in days.

Measures the efficiency of the resolution process.
Min: 0
Target: 5
Max: 30
12
Please provide any comments or observations regarding the effectiveness of the pharmacovigilance system.

Enter your comments here.

Gather qualitative feedback to enhance the system.

13
What is the status of data completeness for adverse event reports?

Select the data completeness status.

Evaluates whether all necessary information is included in reports.
14
What is the current error rate (in percentage) in adverse event reports?

Enter the error rate as a percentage.

Measures the quality and accuracy of reported data.
Min: 0
Target: 2
Max: 100
15
How frequently are stakeholders trained on data entry and reporting procedures?

Select the frequency of training.

Assesses the effectiveness of training programs.
16
Please provide recommendations for improving data quality in reports.

Enter your recommendations here.

Collects suggestions for enhancing the data quality process.

17
How timely is the review process for reported incidents?

Select the timeliness of the incident review process.

Measures the efficiency of the review process in handling incidents.
18
What is the average resolution time (in days) for reported incidents?

Enter the average resolution time in days.

Evaluates the effectiveness of the incident resolution process.
Min: 1
Target: 4
Max: 30
19
Is technology effectively utilized in the adverse event reporting process?

Indicate whether technology is utilized effectively.

Assesses the role of technology in enhancing reporting efficiency.
20
Please provide any suggestions for improving the pharmacovigilance process.

Enter your suggestions here.

Collects feedback for potential enhancements to processes.

FAQs

The primary purpose is to evaluate the completeness, accuracy, and effectiveness of a company's Pharmacovigilance System Master File in accordance with Good Pharmacovigilance Practices.

The frequency of PSMF audits may vary, but it is generally recommended to conduct them annually or whenever significant changes occur in the pharmacovigilance system.

PSMF audits are typically conducted by qualified internal auditors, quality assurance professionals, or external consultants with expertise in pharmacovigilance and GVP requirements.

Key components include the organizational structure, locations, computerized systems, pharmacovigilance processes, quality management system, and contracted activities related to pharmacovigilance.

By ensuring a robust pharmacovigilance system, the checklist helps identify and address potential safety issues, ultimately contributing to improved patient safety and product quality.

Benefits

Ensures comprehensive coverage of all GVP PSMF requirements

Facilitates systematic and consistent auditing processes

Helps identify gaps and areas for improvement in pharmacovigilance systems

Supports regulatory compliance and reduces the risk of non-conformities

Enhances the overall quality and effectiveness of pharmacovigilance activities