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GDP Complaint Handling and Product Recall Audit Checklist

A specialized checklist for auditing GDP compliance in pharmaceutical complaint handling and product recall procedures, focusing on investigation processes, corrective actions, recall execution, and communication protocols.

GDP Complaint Handling and Product Recall Audit Checklist

by: audit-now
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About This Checklist

Effective complaint handling and product recall procedures are critical components of Good Distribution Practice (GDP) in the pharmaceutical industry. This comprehensive GDP Complaint Handling and Product Recall Audit Checklist is designed to help pharmaceutical companies evaluate and improve their processes for managing product complaints and executing recalls when necessary. By focusing on key areas such as complaint investigation, corrective actions, recall procedures, and communication protocols, this checklist enables auditors to thoroughly assess compliance with GDP requirements for these crucial quality assurance processes. Regular use of this checklist can significantly enhance patient safety, improve product quality, and ensure rapid and effective responses to potential product issues throughout the distribution chain.

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Industry

Healthcare

Standard

GDP - Good Distribution Practice

Workspaces

Pharmaceutical Companies

Occupations

Quality Assurance Manager
Regulatory Affairs Specialist
Pharmacovigilance Officer
Supply Chain Manager
Customer Service Representative
1
Is the complaint documentation in compliance with GDP standards?
2
Have corrective actions been implemented for the last complaint received?
3
What is the procedure for product recalls at this facility?
4
Please provide details of the investigation conducted for the most recent complaint.
5
Are staff members trained in quality assurance procedures?
6
What percentage of complaints were resolved within the target timeframe?
Min: 0
Target: 95%
Max: 100
7
When was the last product recall drill conducted?
8
What communication protocols are in place for patient safety issues?
9
Are complaints responded to within the established timeframe?
10
What are the escalation procedures for unresolved complaints?
11
How is customer feedback analyzed to improve complaint handling?
12
When was the last review of complaint handling procedures conducted?
13
Are recall notifications sent to all relevant stakeholders in compliance with regulations?
14
What percentage of recalled products were successfully retrieved?
Min: 0
Target: Above 90%
Max: 100
15
What training do staff receive regarding recall procedures?
16
When was the last simulation of a recall procedure conducted?

FAQs

A complaint handling procedure should include steps for complaint receipt, documentation, investigation, root cause analysis, corrective actions, and feedback to the complainant.

Companies should have systems in place to evaluate and respond to serious complaints within 24-48 hours, with immediate action taken for complaints involving potential patient harm.

Recall procedures should cover different levels of recalls, including customer-level recalls, wholesale-level recalls, and full market withdrawals, based on the severity and extent of the product issue.

This checklist provides a framework for evaluating the comprehensiveness of mock recall exercises, including assessment of response times, communication effectiveness, and product traceability throughout the supply chain.

The audit should assess internal and external communication protocols, including notification to regulatory authorities, healthcare professionals, and patients, as well as coordination with marketing authorization holders and contract manufacturers.

Benefits of GDP Complaint Handling and Product Recall Audit Checklist

Ensures comprehensive evaluation of complaint handling and recall processes

Helps identify gaps in current procedures and response times

Facilitates compliance with GDP requirements for quality assurance

Improves patient safety through effective product issue management

Supports continuous improvement in quality control and risk mitigation