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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

Pharmaceuticals

Standard

Good Distribution Practice (GDP)

Workspaces

Pharmaceutical manufacturing plants

Occupations

Supply Chain Managers
Quality Assurance Specialists
Regulatory Affairs Managers
Security Experts
Logistics Coordinators

Supply Chain Security Audit

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1
What is the assessed risk level for falsified medicines in your supply chain?

Select the risk level.

To understand potential vulnerabilities in the supply chain.
2
When was the last audit conducted for supply chain security?

Select the date of the last audit.

To track the frequency of audits for compliance assurance.
3
What measures are in place to prevent counterfeit products?

List and describe the measures implemented.

To evaluate the effectiveness of counterfeit prevention strategies.
Write something awesome...
4
Is the supply chain compliant with the Drug Supply Chain Security Act?

Select the compliance status.

To confirm adherence to legal requirements for drug supply chain security.
5
What is the accuracy rate of your track-and-trace system?

Enter the accuracy rate as a percentage.

To assess the reliability of the track-and-trace system against counterfeit drugs.
Min: 95
Target: 99
Max: 100
6
Describe the serialization process used for tracking products.

Provide a detailed description of the serialization process.

To ensure compliance with serialization requirements under DSCSA.
7
Is there a formal process in place for qualifying suppliers?

Select the qualification status.

To ensure that suppliers meet the necessary standards for drug security and compliance.
8
Is counterfeit detection technology utilized in your operations?

Select the technology utilization status.

To determine the adoption of technology aimed at preventing counterfeit products.
9
When was the last review conducted for your key suppliers?

Select the date of the last supplier review.

To track the most recent evaluation of supplier performance and compliance.
10
What training programs are in place for staff regarding supply chain security?

List and describe the training programs implemented.

To evaluate the level of awareness and preparedness among staff concerning supply chain security.
Write something awesome...
11
Is your organization prepared for a product recall?

Select the recall readiness status.

To assess the readiness of the organization in the event of a product recall.
12
What is the frequency of audits conducted for your suppliers?

Enter the number of audits conducted per year.

To evaluate how often suppliers are assessed for compliance with quality and safety standards.
Min: 1
Target: 12
Max: 52
13
Describe how your supply chain is mapped from manufacturer to end-user.

Provide a detailed description of the supply chain mapping.

To ensure a clear understanding of the supply chain flow and identify potential vulnerabilities.
14
Is there a monitoring process in place for third-party logistics providers?

Select the monitoring status.

To ensure that third-party providers comply with security standards.
15
When was the last compliance training conducted for supply chain personnel?

Select the date of the last compliance training.

To ensure that staff are updated on compliance requirements.
16
What methods are employed for tracking and tracing pharmaceutical products?

Describe the tracking and tracing methods used.

To assess the effectiveness of product traceability measures.
17
Is there an assessment process for supplier diversity in your supply chain?

Select the assessment status.

To ensure a diverse supplier base that can enhance risk management.
18
What is the average response time for incidents related to supply chain security?

Enter the average response time in hours.

To evaluate the efficiency of the incident response process.
Min: 1
Target: 24
Max: 72
19
Describe the procedures in place for assessing risks in the supply chain.

Provide a detailed overview of the risk assessment procedures.

To understand how risks are identified and managed within the supply chain.
Write something awesome...
20
Have staff received training on the product recall process?

Select the training status.

To confirm that employees are knowledgeable about the recall procedures.
21
When was the last risk assessment conducted for the supply chain?

Select the date of the last risk assessment.

To ensure that risks are regularly evaluated and managed.
22
Describe the process for reporting incidents related to supply chain security.

Provide a detailed description of the incident reporting process.

To assess the effectiveness of incident reporting and resolution.
23
Is your supply chain compliant with WHO Guidelines on Good Distribution Practices?

Select the compliance status.

To ensure adherence to international standards for distribution practices.
24
What percentage of your suppliers have been audited in the last year?

Enter the percentage of suppliers audited.

To measure the thoroughness of supplier audits conducted.
Min: 0
Target: 75
Max: 100
25
What SOPs are in place for ensuring compliance in the supply chain?

Provide a summary of the relevant SOPs.

To evaluate the adequacy of procedures established for compliance.
Write something awesome...
26
Is blockchain technology utilized for traceability in your supply chain?

Select the blockchain utilization status.

To determine the level of technological advancement in tracking products.
27
When was the last comprehensive review of the supply chain conducted?

Select the date of the last review.

To ensure that the supply chain is regularly evaluated for risks and performance.
28
What contingency planning strategies are implemented for supply chain risks?

Describe the contingency planning strategies.

To understand how potential disruptions are being mitigated.
29
Is there a system in place for monitoring supplier compliance with security standards?

Select the monitoring system status.

To ensure ongoing adherence to compliance requirements by suppliers.
30
What is the average lead time for procuring critical supplies?

Enter the average lead time in days.

To assess the efficiency and responsiveness of the supply chain.
Min: 1
Target: 14
Max: 60
31
What is the overview of your emergency response plan for supply chain disruptions?

Provide a summary of the emergency response plan.

To evaluate preparedness for unexpected events affecting the supply chain.
Write something awesome...

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

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