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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
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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

Pharmaceuticals

Standard

EU GDP, WHO GDP, FDA 21 CFR Part 203

Workspaces

Research laboratories

Occupations

Supply Chain Quality Assurance Specialist
Logistics Manager
Distribution Center Manager
Quality Control Analyst
Regulatory Compliance Officer

Pharmaceutical Supply Chain Audit

(0 / 6)

1
Are adequate security measures in place for the supply chain?

Indicate whether security measures are in place.

To verify that security protocols are implemented to protect the supply chain.
2
When was the last quality agreement review conducted?

Enter the date of the last review.

To ensure that quality agreements are regularly reviewed and updated.
3
Is the transportation validation compliant with regulatory requirements?

Select the compliance status of transportation validation.

To ensure that transportation methods meet the standards for pharmaceutical products.
4
Is the product traceability documentation complete and accessible?

Provide details about the traceability documentation.

To ensure that all products can be traced through the supply chain.
5
What is the temperature range maintained for the pharmaceutical inventory?

Enter the temperature range in degrees Celsius.

To verify compliance with cold chain storage requirements.
Min: 2
Target: 2-8°C
Max: 8
6
Is the supplier qualified as per the defined criteria?

Select the qualification status of the supplier.

To ensure that only qualified suppliers are used in the supply chain.
7
Are temperature logs maintained accurately and consistently?

Indicate whether temperature logs are maintained.

To verify that temperature records are kept for accountability.
8
When was the last cold chain audit conducted?

Enter the date of the last audit.

To ensure that audits are regularly performed to assess cold chain compliance.
9
Are personnel trained in cold chain handling procedures?

Select the training compliance status.

To ensure that staff are knowledgeable about proper cold chain management.
10
Is there an emergency response plan for cold chain failures?

Provide details about the emergency response plan.

To ensure that there are procedures in place to address cold chain breaches.
11
What is the maximum allowable temperature deviation for cold chain products?

Enter the maximum temperature deviation allowed in degrees Celsius.

To verify adherence to temperature specifications for cold chain storage.
Min: -2
Target: ±2°C
Max: 2
12
Is the cold chain monitoring system operational and effective?

Select the status of the cold chain monitoring system.

To ensure that temperature-sensitive products are monitored throughout the supply chain.
13
Are corrective action plans in place for supplier issues?

Indicate whether corrective action plans are established.

To ensure that there are processes for addressing supplier-related issues effectively.
14
When was the last supplier evaluation conducted?

Enter the date of the last evaluation.

To verify that suppliers are evaluated regularly to ensure compliance and performance.
15
Is there a current quality agreement with the supplier?

Select the status of the quality agreement.

To ensure that quality agreements are in place to maintain product standards.
16
What is the supplier qualification score based on the assessment?

Enter the supplier qualification score out of 100.

To quantify the qualification process and ensure suppliers meet necessary standards.
Min: 0
Target: 80
Max: 100
17
What performance metrics are used to evaluate the supplier?

List the performance metrics used for evaluation.

To ensure that supplier performance is regularly assessed against defined metrics.
18
What is the risk assessment level of the supplier?

Select the risk assessment level for the supplier.

To evaluate the risk associated with each supplier in the supply chain.
19
Are there established procedures for reporting compliance incidents?

Indicate whether incident reporting procedures are established.

To confirm that there are proper procedures in place for reporting compliance-related incidents.
20
When was the last compliance training conducted for staff?

Enter the date of the last compliance training.

To ensure that staff are regularly trained on compliance requirements.
21
What is the status of the resolution of previous audit findings?

Select the resolution status of audit findings.

To verify that previous audit findings have been addressed and resolved.
22
How often are compliance audits conducted?

Enter the frequency of compliance audits in months.

To ensure that audits are performed at appropriate intervals to maintain compliance.
Min: 1
Target: Yearly
Max: 12
23
Which regulatory guidelines are being followed?

List the regulatory guidelines being followed.

To confirm that the supply chain adheres to specific regulatory guidelines.
24
Is the supply chain fully compliant with regulatory requirements?

Select the regulatory compliance status.

To ensure adherence to all applicable regulations in the pharmaceutical supply chain.
25
Are follow-up actions taken for all corrective actions implemented?

Indicate whether follow-up actions are taken.

To confirm that corrective actions are effectively monitored and evaluated.
26
When was the last comprehensive quality review conducted?

Enter the date of the last quality review.

To ensure that quality reviews are performed regularly to maintain product standards.
27
How frequently are internal quality audits conducted?

Select the frequency of internal audits.

To ensure that internal audits are performed regularly to monitor quality processes.
28
What is the non-conformance rate for products over the last year?

Enter the non-conformance rate as a percentage.

To assess the effectiveness of quality assurance processes.
Min: 0
Target: 5
Max: 100
29
Is all quality assurance documentation up to date?

Provide details about the current quality assurance documentation.

To verify that all necessary documentation is current and accessible for review.
30
Are quality control tests conducted according to the established protocols?

Select the compliance status of quality control testing.

To ensure that all products meet the quality standards set forth in the protocols.

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

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