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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?
2
What is the average time (in days) taken to report adverse events?
Min: 0
Target: 3
Max: 30
3
How would you rate the training compliance of staff in pharmacovigilance?
4
Have all previous GVP audit findings been addressed?
5
What is the risk assessment level of the reported adverse events?
6
When was the last pharmacovigilance audit conducted?
7
What percentage of adverse event reports were submitted on time?
Min: 0
Target: 95
Max: 100
8
How satisfied are stakeholders with the current reporting process?
9
How compliant is the organization with the established reporting guidelines?
10
Is there an integrated feedback mechanism for reporting adverse events?
11
What is the average time (in days) taken to resolve adverse event reports?
Min: 0
Target: 5
Max: 30
12
Please provide any comments or observations regarding the effectiveness of the pharmacovigilance system.
13
What is the status of data completeness for adverse event reports?
14
What is the current error rate (in percentage) in adverse event reports?
Min: 0
Target: 2
Max: 100
15
How frequently are stakeholders trained on data entry and reporting procedures?
16
Please provide recommendations for improving data quality in reports.
17
How timely is the review process for reported incidents?
18
What is the average resolution time (in days) for reported incidents?
Min: 1
Target: 4
Max: 30
19
Is technology effectively utilized in the adverse event reporting process?
20
Please provide any suggestions for improving the pharmacovigilance process.

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 of GVP Pharmacovigilance System Master File (PSMF) Audit Checklist

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