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Pharmaceutical Pharmacovigilance and Drug Safety Audit Checklist

A comprehensive checklist for auditing pharmacovigilance and drug safety processes in pharmaceutical companies to ensure regulatory compliance, patient safety, and effective risk management.

Pharmaceutical Pharmacovigilance and Drug Safety Audit Checklist
by: audit-now
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About This Checklist

Pharmacovigilance is critical in ensuring the ongoing safety of pharmaceutical products post-marketing. This Pharmaceutical Pharmacovigilance and Drug Safety Audit Checklist is a vital tool for evaluating the effectiveness and compliance of pharmacovigilance systems and processes. By systematically assessing adverse event reporting, signal detection, risk management plans, periodic safety update reports, and regulatory communications, this checklist helps maintain robust drug safety monitoring and timely response to emerging safety concerns. Regular implementation of this comprehensive audit process can significantly enhance patient safety, improve regulatory compliance, and support the ongoing benefit-risk assessment of pharmaceutical products throughout their lifecycle.

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Industry

Pharmaceuticals

Standard

ICH E2A-E2F, EU GVP, FDA Pharmacovigilance Guidance

Workspaces

Research laboratories

Occupations

Pharmacovigilance Auditor
Drug Safety Specialist
Regulatory Affairs Manager
Medical Safety Officer
Quality Assurance Manager

Pharmacovigilance Audit Questions

(0 / 5)

1
Is the safety database management compliant with FDA Pharmacovigilance Guidance?

Select compliance status.

To verify compliance with FDA standards for managing safety data.
2
When was the last periodic safety update report submitted?

Select the submission date.

To ensure timely submission of safety updates as per regulatory requirements.
3
Please describe the current status of the risk management plan for the drug.

Provide a detailed description.

To evaluate the effectiveness and implementation of the risk management plan.
4
What is the frequency of signal detection reviews conducted in the last quarter?

Enter the number of reviews conducted.

To assess the frequency of signal detection activities related to drug safety.
Target: 4
5
Is the adverse event reporting process compliant with ICH E2A-E2F and EU GVP guidelines?

Select compliance status.

To ensure adherence to regulatory requirements for reporting adverse events.
6
Are staff members trained regularly on data entry protocols and compliance measures?

Select training compliance status.

To verify that personnel are adequately trained to ensure data integrity.
7
When was the last data quality audit conducted?

Select the date of the last audit.

To ensure that regular audits are performed to maintain data quality.
8
What is the acceptable error rate for data entry in the safety database?

Enter the maximum acceptable error rate.

To determine the thresholds for acceptable data quality.
Target: 2
9
Describe the process for reviewing incident reports for completeness and accuracy.

Provide a detailed description of the review process.

To assess the thoroughness of the review process for incident reports.
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10
What measures are in place to ensure the accuracy of data entries in the safety database?

Describe the measures.

To evaluate the procedures implemented to maintain data integrity.
11
Is the action plan for addressing identified risks currently being implemented?

Select the status of action plan implementation.

To verify that actions are taken on identified risks.
12
When was the last risk assessment conducted?

Select the date of the last risk assessment.

To ensure that risk assessments are being regularly updated.
13
What is the current risk rating for the pharmacovigilance system?

Enter the risk rating on a scale of 1 to 5.

To assess the overall risk level associated with the pharmacovigilance operations.
Target: 3
14
What risk mitigation strategies are in place for identified risks?

Describe the risk mitigation strategies.

To evaluate the effectiveness of strategies implemented to address potential risks.
15
How frequently are risk assessments conducted for the pharmacovigilance system?

Select the frequency of risk assessments.

To ensure that risk assessments are performed regularly to identify potential issues.
16
Is there a corrective action plan in place for any recent compliance findings?

Select the status of the corrective action plan.

To verify the existence of a plan to address compliance issues.
17
When was the last compliance audit conducted?

Select the date of the last compliance audit.

To ensure that compliance audits are performed regularly.
18
How often are compliance audits performed on the pharmacovigilance system?

Enter the number of audits conducted per year.

To ensure routine checks are in place for maintaining compliance.
Target: 6
19
What records are maintained to ensure staff are trained on regulatory compliance?

Describe the training records maintained.

To verify that adequate training records are kept for compliance purposes.
20
Are regulatory submissions made within the required timeframes as per ICH E2A-E2F guidelines?

Select the compliance status for submission timelines.

To ensure compliance with submission timelines set by regulatory authorities.
21
Are staff members provided with training on quality assurance practices?

Select the training compliance status.

To verify that personnel are educated on maintaining quality standards.
22
When was the last quality review conducted for pharmacovigilance processes?

Select the date of the last quality review.

To ensure that regular quality reviews are part of the process.
23
What is the average time taken to resolve quality issues identified in pharmacovigilance?

Enter the average resolution time in days.

To evaluate the responsiveness of the system in addressing quality concerns.
Target: 10
24
What quality metrics are monitored to evaluate the effectiveness of the pharmacovigilance system?

List the quality metrics being monitored.

To assess the key performance indicators that gauge the system's quality.
25
Is there an established quality assurance program for pharmacovigilance activities?

Select the status of the quality assurance program.

To confirm the presence of a structured program aimed at ensuring quality in pharmacovigilance.

FAQs

Comprehensive pharmacovigilance audits should be conducted annually. However, specific processes or high-risk areas may require more frequent audits, and additional audits should be performed following significant changes to the pharmacovigilance system.

This checklist covers adverse event collection and reporting processes, signal detection and evaluation methods, risk management plan implementation, periodic safety update report preparation, literature monitoring, safety database management, and regulatory compliance with global pharmacovigilance requirements.

These audits are typically conducted by qualified pharmacovigilance auditors, drug safety specialists, or quality assurance professionals with expertise in global pharmacovigilance regulations and best practices.

The checklist ensures that all aspects of the pharmacovigilance system meet regulatory requirements, including timely reporting of adverse events, proper signal management, and accurate benefit-risk assessments, which are crucial for maintaining product safety and regulatory compliance.

If significant non-conformities are identified, actions should include immediate assessment of the impact on patient safety, implementation of corrective and preventive measures, potential reporting to regulatory authorities, review of affected processes or products, and enhanced monitoring. All actions must be thoroughly documented and followed up.

Benefits

Ensures compliance with global pharmacovigilance regulations and guidelines

Enhances early detection and management of drug safety signals

Improves the quality and timeliness of safety reporting to regulatory authorities

Reduces risks associated with delayed or inadequate safety measures

Facilitates continuous improvement of drug safety monitoring processes