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GDP Supplier and Contractor Management Audit Checklist

A specialized checklist for auditing GDP compliance in pharmaceutical supplier and contractor management, focusing on qualification, quality agreements, performance monitoring, and risk assessment of third-party partners.

GDP Supplier and Contractor Management Audit Checklist

by: audit-now
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About This Checklist

Effective management of suppliers and contractors is crucial for maintaining Good Distribution Practice (GDP) compliance in the pharmaceutical industry. This comprehensive GDP Supplier and Contractor Management Audit Checklist is designed to help pharmaceutical companies evaluate and improve their processes for selecting, qualifying, and monitoring third-party partners involved in the distribution chain. By addressing key areas such as supplier qualification, quality agreements, performance monitoring, and risk assessment, this checklist enables auditors to thoroughly assess compliance with GDP requirements for outsourced activities. Regular use of this checklist can significantly reduce risks associated with substandard services, enhance supply chain integrity, and ensure consistent quality throughout the pharmaceutical distribution network.

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Industry

Healthcare

Standard

GDP - Good Distribution Practice

Workspaces

Pharmaceutical Companies

Occupations

Procurement Manager
Supplier Quality Assurance Specialist
Contract Manager
Supply Chain Auditor
Vendor Relations Coordinator
1
Is the supplier qualified according to GDP compliance?
2
Have quality agreements with suppliers been reviewed and updated?
3
Is there an established performance monitoring process for contractors?
4
What is the risk assessment score for the supplier?
Min: 1
Target: 3
Max: 5
5
Is there a review process for third-party partnerships?
6
Is the contractor compliant with GDP requirements?
7
Are all necessary compliance documents available?
8
When is the next audit scheduled for this contractor?
9
How many incident reports have been filed against the contractor in the last year?
Min: 0
Target: 2
Max: 100
10
What corrective actions have been implemented following previous audits?
11
Is the supplier's quality assurance program compliant with GDP standards?
12
What quality control processes are implemented by the supplier?
13
What is the current defect rate percentage for products supplied?
Min: 0
Target: 1.5
Max: 100
14
When was the last quality audit conducted for the supplier?
15
Is there a corrective action plan established for quality issues?

FAQs

A quality agreement should clearly define responsibilities, quality standards, communication protocols, change control procedures, and processes for handling deviations and complaints.

This checklist provides a framework for establishing key performance indicators (KPIs), conducting regular performance reviews, and implementing corrective and preventive actions based on supplier performance data.

Risk assessment should consider factors such as the criticality of the supplied service or product, the supplier's GDP compliance history, geographical location, and the potential impact of service failures on product quality and patient safety.

Qualification criteria should include the supplier's GDP compliance status, quality management systems, regulatory history, financial stability, and capacity to meet service level agreements.

The frequency of supplier audits should be based on risk assessment, but typically critical suppliers should be audited at least once every 2-3 years, with more frequent audits for high-risk suppliers.

Benefits of GDP Supplier and Contractor Management Audit Checklist

Ensures thorough evaluation of supplier and contractor management practices

Helps identify potential risks in outsourced distribution activities

Facilitates compliance with GDP requirements for third-party partnerships

Improves supply chain integrity and consistency in quality standards

Supports continuous improvement in supplier performance and relationships