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Pharmaceutical Supply Chain Management Audit Checklist

A comprehensive checklist for auditing pharmaceutical supply chain management practices to ensure product quality and integrity

Pharmaceutical Supply Chain Management Audit Checklist

by: audit-now
4.6

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About This Checklist

The Pharmaceutical Supply Chain Management Audit Checklist is a vital tool for ensuring the integrity, quality, and safety of pharmaceutical products throughout the supply chain. This comprehensive checklist addresses key aspects of supply chain management, including supplier qualification, transportation conditions, storage practices, and traceability systems. By systematically evaluating your supply chain processes against industry standards and regulatory requirements, you can identify vulnerabilities, implement necessary controls, and maintain the quality of pharmaceutical products from manufacturing to end-user delivery. Regular use of this checklist helps prevent drug counterfeiting, ensures proper handling of temperature-sensitive products, and demonstrates compliance with Good Distribution Practice (GDP) guidelines.

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Industry

Healthcare

Standard

GDP - Good Distribution Practice

Workspaces

Pharmaceutical Wholesalers
Transportation Areas
Warehouses
Distribution Centers

Occupations

Supply Chain Manager
Quality Assurance Specialist
Logistics Coordinator
Regulatory Affairs Manager
Procurement Officer
1
Is the temperature control system functioning within the specified limits?

Select compliance status.

To ensure that drug quality and product integrity are maintained during storage and transport.
2
What percentage of traceability records are accurate?

Enter percentage of accuracy.

To verify the integrity of the pharmaceutical supply chain and ensure compliance with GDP.
Min: 0
Target: 100
Max: 100
3
Are anti-counterfeiting measures in place and effective?

Select effectiveness of anti-counterfeiting measures.

To protect against counterfeit products entering the supply chain.
4
Describe any incidents related to product integrity during the previous audit period.

Provide details of incidents.

To identify trends or recurring issues that need to be addressed to maintain drug quality.

FAQs

The checklist covers areas such as supplier qualification, transportation validation, storage conditions, inventory management, product traceability, and quality agreements with third-party logistics providers.

Supply chain audits should be conducted at least annually, with more frequent audits for high-risk suppliers or critical distribution routes.

The audit team should include supply chain managers, quality assurance professionals, regulatory affairs specialists, and logistics experts.

The checklist ensures that proper controls are in place throughout the supply chain to maintain product quality, including temperature monitoring, handling procedures, and anti-counterfeiting measures.

Yes, while the core principles remain the same, the checklist can be adapted to address specific requirements of different product types, such as cold chain products, controlled substances, or biologics.

Benefits

Improves product quality and patient safety through enhanced traceability

Supports prevention of drug counterfeiting and diversion

Enhances overall supply chain efficiency and reliability

Ensures compliance with Good Distribution Practice (GDP) guidelines

Helps identify and mitigate risks in the pharmaceutical supply chain