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Pharmaceutical Supply Chain Security Audit Checklist

A comprehensive audit checklist for evaluating pharmaceutical supply chain security practices, ensuring regulatory compliance, and maintaining product integrity from manufacturer to patient.

Pharmaceutical Supply Chain Security Audit Checklist

by: audit-now
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About This Checklist

In the pharmaceutical industry, ensuring the integrity and security of the supply chain is critical to prevent counterfeiting, diversion, and contamination of medicinal products. This Supply Chain Security Audit Checklist is designed to evaluate and enhance the robustness of pharmaceutical supply chain management practices. By systematically assessing supplier qualifications, track-and-trace systems, storage conditions, transportation security, and documentation processes, this checklist helps identify vulnerabilities, mitigate risks, and maintain compliance with regulatory requirements for pharmaceutical supply chain integrity.

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Industry

Healthcare

Standard

GDP - Good Distribution Practice

Workspaces

Pharmaceutical Manufacturing Facilities

Occupations

Supply Chain Managers
Quality Assurance Specialists
Regulatory Affairs Managers
Security Experts
Logistics Coordinators
1
Is there a formal process in place for qualifying suppliers?
2
Describe the serialization process used for tracking products.
3
What is the accuracy rate of your track-and-trace system?
Min: 95
Target: 99
Max: 100
4
Is the supply chain compliant with the Drug Supply Chain Security Act?
5
What measures are in place to prevent counterfeit products?
6
When was the last audit conducted for supply chain security?
7
What is the assessed risk level for falsified medicines in your supply chain?
8
Describe how your supply chain is mapped from manufacturer to end-user.
9
What is the frequency of audits conducted for your suppliers?
Min: 1
Target: 12
Max: 52
10
Is your organization prepared for a product recall?
11
What training programs are in place for staff regarding supply chain security?
12
When was the last review conducted for your key suppliers?
13
Is counterfeit detection technology utilized in your operations?
14
Describe the procedures in place for assessing risks in the supply chain.
15
What is the average response time for incidents related to supply chain security?
Min: 1
Target: 24
Max: 72
16
Is there an assessment process for supplier diversity in your supply chain?
17
What methods are employed for tracking and tracing pharmaceutical products?
18
When was the last compliance training conducted for supply chain personnel?
19
Is there a monitoring process in place for third-party logistics providers?
20
What SOPs are in place for ensuring compliance in the supply chain?
21
What percentage of your suppliers have been audited in the last year?
Min: 0
Target: 75
Max: 100
22
Is your supply chain compliant with WHO Guidelines on Good Distribution Practices?
23
Describe the process for reporting incidents related to supply chain security.
24
When was the last risk assessment conducted for the supply chain?
25
Have staff received training on the product recall process?
26
What is the overview of your emergency response plan for supply chain disruptions?
27
What is the average lead time for procuring critical supplies?
Min: 1
Target: 14
Max: 60
28
Is there a system in place for monitoring supplier compliance with security standards?
29
What contingency planning strategies are implemented for supply chain risks?
30
When was the last comprehensive review of the supply chain conducted?
31
Is blockchain technology utilized for traceability in your supply chain?

FAQs

Key components include supplier qualification, serialization and track-and-trace systems, secure transportation, proper storage conditions, and robust documentation practices.

Audits should be conducted annually for critical suppliers and processes, with more frequent assessments for high-risk areas or new supply chain partners.

Audits should involve a cross-functional team including quality assurance, supply chain managers, security experts, and regulatory affairs specialists.

The checklist incorporates requirements from global regulations such as the EU Falsified Medicines Directive and the US Drug Supply Chain Security Act to ensure comprehensive compliance.

Yes, the checklist can be adapted to address specific security requirements for various product types, including small molecules, biologics, and temperature-sensitive medications.

Benefits of Pharmaceutical Supply Chain Security Audit Checklist

Enhances protection against counterfeit drugs and supply chain breaches

Ensures compliance with track-and-trace regulations and serialization requirements

Improves supplier qualification and management processes

Optimizes inventory control and reduces the risk of product diversion

Supports patient safety by maintaining product integrity throughout the supply chain