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Pharmaceutical Pharmacovigilance System Audit Checklist

A comprehensive audit checklist for evaluating pharmaceutical pharmacovigilance systems, ensuring regulatory compliance, and maintaining the highest standards in drug safety monitoring and risk management practices.

Pharmaceutical Pharmacovigilance System Audit Checklist
by: audit-now
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About This Checklist

Pharmacovigilance is a critical function in the pharmaceutical industry, focusing on the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problems. This Pharmacovigilance System Audit Checklist is designed to comprehensively evaluate the effectiveness and compliance of pharmacovigilance processes within pharmaceutical organizations. By systematically assessing adverse event reporting, signal detection, risk management, safety communications, and quality management systems, this checklist helps identify potential gaps in pharmacovigilance practices, ensures regulatory compliance, and ultimately contributes to patient safety and public health protection. Regular use of this checklist supports continuous improvement in drug safety monitoring and promotes a robust safety culture within the organization.

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Industry

Healthcare

Standard

Pharmacovigilance Standards

Workspaces

Pharmaceutical Manufacturing Facilities

Occupations

Pharmacovigilance Managers
Drug Safety Officers
Medical Affairs Specialists
Regulatory Affairs Managers
Quality Assurance Auditors

1
Is the adverse event reporting process compliant with EMA GVP and FDA regulations?

Select the compliance status.

To ensure that adverse events are reported in accordance with regulatory standards.
2
How many signal detection activities were conducted in the last quarter?

Enter the number of signal detection activities.

To assess the frequency of signal detection activities performed.
Min: 0
Target: 5
Max: 100
3
Please provide a summary of the current risk management plan for the product.

Summarize the risk management plan.

To evaluate the adequacy and effectiveness of the risk management plan.
4
Are the Periodic Safety Update Reports (PSURs) submitted on time?

Select the submission status.

To ensure timely compliance with reporting requirements.

5
Is access to the safety database restricted to authorized personnel only?

Select the access control status.

To ensure that sensitive data is protected and only accessible by trained individuals.
6
What is the percentage of data entry errors identified in the last reporting period?

Enter the percentage of data entry errors.

To evaluate the accuracy of data entered into the safety database.
Min: 0
Target: 2
Max: 10
7
Describe the process for reviewing data quality within the safety database.

Provide a detailed description of the data quality review process.

To ensure that a systematic process is in place for maintaining data quality.
8
Is the post-marketing surveillance conducted in accordance with regulatory requirements?

Select the compliance status.

To ensure compliance with regulations regarding post-marketing activities.

9
Is the risk assessment process documented and regularly updated?

Select the documentation status.

To ensure that the risk assessment process is transparent and in line with regulatory standards.
10
How many risks were identified during the last risk assessment?

Enter the number of identified risks.

To evaluate the comprehensiveness of the risk assessment process.
Min: 0
Target: 3
Max: 50
11
Please provide a summary of the mitigation strategies for the identified risks.

Summarize the mitigation strategies.

To ensure that sufficient strategies are in place to address identified risks.
12
When was the last risk assessment conducted?

Select the date of the last risk assessment.

To track the frequency of risk assessments and ensure regulatory compliance.

FAQs

The checklist covers adverse event collection and reporting, signal detection and evaluation, risk management planning, periodic safety update reports (PSURs), safety database management, and quality management systems for pharmacovigilance.

Comprehensive audits should be conducted annually, with more frequent assessments of high-risk areas or processes. Additionally, targeted audits may be performed in response to significant changes in regulations or internal processes.

The audit team should include pharmacovigilance experts, quality assurance specialists, medical affairs representatives, and regulatory affairs professionals familiar with current pharmacovigilance regulations and best practices.

The checklist incorporates requirements from major global regulations such as EMA's Good Pharmacovigilance Practices (GVP), FDA's postmarketing safety reporting requirements, and ICH guidelines to ensure comprehensive global compliance.

Yes, the checklist is designed to be applicable to pharmacovigilance systems for both small molecule drugs and biological products, with specific sections addressing unique requirements for each product type when necessary.

Benefits

Ensures compliance with global pharmacovigilance regulations and guidelines

Enhances the effectiveness of adverse event detection and reporting processes

Improves risk management and minimization strategies for marketed products

Strengthens the quality management system for pharmacovigilance activities

Supports timely and accurate safety communications to stakeholders