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Pharmaceutical Serialization and Track-and-Trace Audit Checklist

A comprehensive checklist for auditing pharmaceutical serialization and track-and-trace systems to ensure compliance with global regulations, enhance supply chain security, and combat counterfeit drugs.

Pharmaceutical Serialization and Track-and-Trace Audit Checklist

by: audit-now
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About This Checklist

Serialization and track-and-trace systems are crucial in the pharmaceutical industry for ensuring product authenticity, enhancing supply chain security, and combating counterfeit drugs. This Pharmaceutical Serialization and Track-and-Trace Audit Checklist is designed to comprehensively evaluate the implementation and effectiveness of serialization processes throughout the pharmaceutical supply chain. By assessing factors such as unique identifier generation, packaging line integration, data management, and regulatory compliance, this checklist helps pharmaceutical companies maintain robust anti-counterfeiting measures. Implementing this audit process can significantly improve product traceability, enhance patient safety, and ensure compliance with global serialization regulations.

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Industry

Healthcare

Standard

Pharmaceutical Supply Chain Security Standards

Workspaces

Pharmaceutical Distribution Centers

Occupations

Serialization Project Manager
Supply Chain Specialist
Packaging Technology Manager
IT Systems Integrator
Regulatory Compliance Officer
1
Is the serialization of all products in compliance with the EU Falsified Medicines Directive?

Select the compliance status.

To ensure adherence to regulatory requirements for product serialization.
2
How many unique identifiers are verified during this audit?

Enter the number of unique identifiers verified.

To assess the volume of product identifiers being tracked.
Min: 0
Target: 100
Max: 1000
3
Is the track-and-trace system fully operational?

Indicate if the system is operational.

To confirm the system's capability to trace products throughout the supply chain.
4
Are effective anti-counterfeiting measures in place?

Select the status of anti-counterfeiting measures.

To ensure that the products are protected against counterfeiting.
5
Are the product authentication methods in place effective?

Select the effectiveness status of authentication methods.

To evaluate the reliability of methods used for product authentication.
6
What issues were encountered during the authentication process?

Describe any issues encountered.

To document any challenges faced that could impact traceability.
7
What is the accuracy rate of traceability for the products audited?

Enter the accuracy rate as a percentage.

To measure the effectiveness of traceability processes.
Min: 0
Target: 95
Max: 100
8
When was the last audit conducted on the traceability system?

Select the date of the last audit.

To ensure regular audits are performed for compliance.

FAQs

The checklist covers unique identifier generation and allocation, packaging line equipment and processes, data management systems, integration with enterprise systems, aggregation and de-aggregation processes, and compliance with country-specific serialization requirements.

These audits should be conducted at least annually, with more frequent assessments recommended during initial implementation phases or when significant changes are made to serialization processes or regulations.

These audits are usually conducted by a cross-functional team including serialization specialists, quality assurance professionals, IT experts, and supply chain managers, often supported by external consultants with expertise in pharmaceutical serialization regulations.

By ensuring robust serialization processes, this checklist helps create a secure, traceable supply chain that makes it extremely difficult for counterfeit products to enter the legitimate distribution network, thereby protecting patients from potentially harmful fake medicines.

Yes, this checklist is designed to be adaptable to different global markets. It includes considerations for various regional regulations such as the EU Falsified Medicines Directive, US DSCSA, and other country-specific serialization requirements.

Benefits of Pharmaceutical Serialization and Track-and-Trace Audit Checklist

Ensures compliance with global serialization and traceability regulations

Enhances protection against counterfeit and falsified medicines

Improves supply chain visibility and product recall efficiency

Supports patient safety through verified product authenticity

Facilitates accurate inventory management and reduces supply chain errors