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Pharmaceutical Supply Chain Management Audit Checklist

A comprehensive checklist for auditing supply chain management processes in the pharmaceutical industry to ensure product quality, integrity, and regulatory compliance throughout the distribution network.

Pharmaceutical Supply Chain Management Audit Checklist

by: audit-now
4.6

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About This Checklist

Effective supply chain management is crucial in the pharmaceutical industry to ensure product quality, integrity, and patient safety from manufacturing to end-user delivery. This Pharmaceutical Supply Chain Management Audit Checklist is a vital tool for evaluating the robustness and compliance of supply chain processes. By systematically assessing supplier qualification, inventory management, transportation conditions, product traceability, and quality agreements, this checklist helps maintain regulatory compliance and product integrity throughout the supply chain. Regular implementation of this comprehensive audit process can significantly reduce risks of product contamination, counterfeiting, and supply disruptions, while enhancing overall supply chain efficiency and reliability.

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Industry

Healthcare

Standard

GDP - Good Distribution Practice

Workspaces

Research Facilities

Occupations

Supply Chain Quality Assurance Specialist
Logistics Manager
Distribution Center Manager
Quality Control Analyst
Regulatory Compliance Officer
1
Is the supplier qualified as per the defined criteria?
2
What is the temperature range maintained for the pharmaceutical inventory?
Min: 2
Target: 2-8°C
Max: 8
3
Is the product traceability documentation complete and accessible?
4
Is the transportation validation compliant with regulatory requirements?
5
When was the last quality agreement review conducted?
6
Are adequate security measures in place for the supply chain?
7
Is the cold chain monitoring system operational and effective?
8
What is the maximum allowable temperature deviation for cold chain products?
Min: -2
Target: ±2°C
Max: 2
9
Is there an emergency response plan for cold chain failures?
10
Are personnel trained in cold chain handling procedures?
11
When was the last cold chain audit conducted?
12
Are temperature logs maintained accurately and consistently?
13
What is the risk assessment level of the supplier?
14
What performance metrics are used to evaluate the supplier?
15
What is the supplier qualification score based on the assessment?
Min: 0
Target: 80
Max: 100
16
Is there a current quality agreement with the supplier?
17
When was the last supplier evaluation conducted?
18
Are corrective action plans in place for supplier issues?
19
Is the supply chain fully compliant with regulatory requirements?
20
Which regulatory guidelines are being followed?
21
How often are compliance audits conducted?
Min: 1
Target: Yearly
Max: 12
22
What is the status of the resolution of previous audit findings?
23
When was the last compliance training conducted for staff?
24
Are there established procedures for reporting compliance incidents?
25
Are quality control tests conducted according to the established protocols?
26
Is all quality assurance documentation up to date?
27
What is the non-conformance rate for products over the last year?
Min: 0
Target: 5
Max: 100
28
How frequently are internal quality audits conducted?
29
When was the last comprehensive quality review conducted?
30
Are follow-up actions taken for all corrective actions implemented?

FAQs

Supply chain audits should be conducted annually for critical suppliers and distributors. However, the frequency may increase based on risk assessment, past performance, or significant changes in the supply chain.

This checklist covers supplier and distributor qualification, warehouse conditions and practices, transportation validation, cold chain management, inventory control systems, product serialization and traceability, quality agreements, and supply chain security measures.

These audits are typically conducted by supply chain quality assurance specialists, logistics managers, or third-party auditors with expertise in pharmaceutical supply chain regulations and best practices.

The checklist ensures that all aspects of the supply chain meet GDP and other regulatory standards, including storage conditions, transportation practices, and documentation, which are crucial for maintaining product quality and integrity.

If significant non-conformities are identified, actions should include immediate risk assessment of product quality impact, implementation of corrective measures, potential disqualification of suppliers or distributors, review of affected product batches, and enhancement of monitoring processes. All actions must be thoroughly documented and followed up.

Benefits of Pharmaceutical Supply Chain Management Audit Checklist

Ensures compliance with GDP (Good Distribution Practice) and regulatory requirements

Reduces risks of product quality compromise during storage and transportation

Improves traceability and recall readiness across the supply chain

Enhances security measures against counterfeiting and diversion

Optimizes inventory management and reduces supply chain disruptions