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GVP Module VI - Management and Reporting of Adverse Reactions Audit Checklist

A comprehensive checklist for auditing the processes of management and reporting of adverse reactions in compliance with GVP Module VI requirements.

GVP Module VI - Management and Reporting of Adverse Reactions Audit Checklist

by: audit-now
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About This Checklist

The GVP Module VI Audit Checklist is a crucial tool for evaluating compliance with the management and reporting of adverse reactions in the pharmaceutical industry. This comprehensive checklist assists auditors and pharmacovigilance professionals in assessing the effectiveness of processes related to the collection, data management, and reporting of suspected adverse reactions. By systematically reviewing key elements of adverse reaction management, this checklist helps identify areas for improvement, ensures regulatory compliance, and ultimately contributes to enhanced patient safety and product quality.

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Industry

Healthcare

Standard

Pharmacovigilance Standards

Workspaces

Pharmacovigilance departments
Research Facilities
Pharmaceutical Offices

Occupations

Pharmacovigilance Auditor
Drug Safety Specialist
Regulatory Affairs Manager
Quality Assurance Professional
Clinical Safety Scientist
1
Is the adverse reaction reporting process compliant with GVP Module VI?
2
What is the average time taken to report adverse reactions (in hours)?
Min: 1
Target: 24
Max: 72
3
What feedback have you received regarding the adverse reaction reporting system?
4
Is staff training on adverse reaction reporting completed?
5
When was the last audit conducted for adverse reaction reporting?
6
What is the action status of the findings from the previous audit?
7
What are the key findings from the recent adverse reaction investigation?
8
Have follow-up actions been initiated based on the adverse reaction investigation?
9
How many adverse reactions have been investigated in the past year?
Min: 0
Target: 50
Max: 1000
10
When did the most recent investigation into adverse reactions start?
11
What was the outcome of the investigation into the adverse reactions?
12
What recommendations can be made to prevent similar adverse reactions in the future?
13
Is the training on adverse reaction reporting completed by all relevant staff?
14
How many training sessions on adverse reaction reporting have been conducted in the past year?
Min: 0
Target: 12
Max: 50
15
Are the training materials on adverse reaction reporting available for staff access?
16
When was the last training session on adverse reaction reporting held?
17
What was the feedback rating from participants of the last training session?
18
What suggestions do participants have for improving future training sessions?
19
What data sources were utilized for analyzing adverse reactions?
20
How many adverse reactions were analyzed in the last reporting period?
Min: 0
Target: 150
Max: 1000
21
What method was used for the data analysis of adverse reactions?
22
When was the data analysis for adverse reactions completed?
23
What is the impact of the analysis findings on safety protocols?
24
What recommendations were made based on the data analysis?
25
How would you rate the usability of the adverse reaction reporting system?
26
What incidents of system downtime have been reported in the last year?
27
What is the average response time of the reporting system (in seconds)?
Min: 1
Target: 5
Max: 30
28
When was the last update applied to the adverse reaction reporting system?
29
Are users adequately trained on how to use the adverse reaction reporting system?
30
What feedback do users have regarding potential improvements for the reporting system?

FAQs

The main focus is to assess the processes for collection, management, and reporting of suspected adverse reactions in accordance with GVP Module VI requirements.

By ensuring proper management and timely reporting of adverse reactions, the checklist helps maintain an up-to-date safety profile of medicinal products, contributing to patient safety.

The checklist should be used by pharmacovigilance auditors, quality assurance specialists, and regulatory affairs professionals responsible for ensuring compliance with adverse reaction reporting requirements.

The checklist covers areas such as adverse reaction collection methods, data quality management, expedited reporting processes, periodic safety update report preparation, and signal detection activities.

Audits should be conducted periodically, typically annually, or more frequently if significant changes occur in the pharmacovigilance system or regulatory requirements.

Benefits of GVP Module VI - Management and Reporting of Adverse Reactions Audit Checklist

Ensures thorough evaluation of adverse reaction management processes

Facilitates compliance with GVP Module VI requirements

Helps identify gaps in adverse reaction reporting and management

Supports continuous improvement of pharmacovigilance activities

Enhances the quality and timeliness of safety data submission to regulatory authorities