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GDP Complaint Handling and Product Recall Audit Checklist
by: audit-now
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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.

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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

Pharmaceuticals

Standard

Good Distribution Practice (GDP)

Workspaces

Pharmaceutical Companies and Distribution Centers

Occupations

Quality Assurance Manager
Regulatory Affairs Specialist
Pharmacovigilance Officer
Supply Chain Manager
Customer Service Representative

GDP Complaint Handling and Product Recall Audit Checklist

1
Auditor Name
2
Site/Location
3
Date

Complaint Handling and Recall Procedures

(0 / 4)

4
Is the complaint documentation in compliance with GDP standards?

Select compliance status.

To ensure adherence to regulatory requirements for complaint handling.
5
Have corrective actions been implemented for the last complaint received?

Indicate whether corrective actions have been implemented.

To verify that necessary corrective measures are taken to improve processes.
6
What is the procedure for product recalls at this facility?

Provide the recall procedure details.

To assess the documented process for handling product recalls.
7
Please provide details of the investigation conducted for the most recent complaint.

Enter investigation details.

To evaluate the thoroughness of the complaint investigation.
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8
Are staff members trained in quality assurance procedures?

Select the training compliance status.

To ensure that all personnel are adequately trained to maintain product quality.
9
What percentage of complaints were resolved within the target timeframe?

Enter the percentage of complaints resolved on time.

To measure the effectiveness of the complaint resolution process.
Lower: 0Target: 95%Upper: 100
10
When was the last product recall drill conducted?

Select the date of the last recall drill.

To ensure that recall procedures are regularly practiced.
11
What communication protocols are in place for patient safety issues?

Provide details of the communication protocols.

To assess the effectiveness of communication strategies regarding patient safety.
12
Are complaints responded to within the established timeframe?

Select the timeliness status of complaint responses.

To ensure responsiveness in complaint management.
13
What are the escalation procedures for unresolved complaints?

Provide details of the escalation procedures.

To evaluate the effectiveness of escalation processes in complaint handling.
14
How is customer feedback analyzed to improve complaint handling?

Describe the feedback analysis process.

To assess the methods used for analyzing customer feedback.
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15
When was the last review of complaint handling procedures conducted?

Select the date of the last complaint review.

To ensure that complaint handling procedures are regularly evaluated.
16
Are recall notifications sent to all relevant stakeholders in compliance with regulations?

Select the compliance status of recall notifications.

To ensure that all parties are informed promptly in the event of a recall.
17
What percentage of recalled products were successfully retrieved?

Enter the percentage of products successfully retrieved during the last recall.

To measure the effectiveness of recall procedures.
Lower: 0Target: Above 90%Upper: 100
18
What training do staff receive regarding recall procedures?

Provide details of the training provided to staff.

To ensure that personnel are adequately trained on recall protocols.
19
When was the last simulation of a recall procedure conducted?

Select the date of the last recall simulation.

To confirm that recall procedures are practiced regularly.

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

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

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