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Pharmaceutical Serialization and Track-and-Trace Audit Checklist

A comprehensive audit checklist for evaluating serialization and track-and-trace systems, procedures, and compliance in pharmaceutical distribution centers

Pharmaceutical Serialization and Track-and-Trace Audit Checklist

by: audit-now
4.1

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About This Checklist

Serialization and track-and-trace systems are crucial in the pharmaceutical industry for combating counterfeiting, ensuring product authenticity, and facilitating efficient recalls. This comprehensive audit checklist is designed to evaluate the implementation and effectiveness of serialization and track-and-trace processes in pharmaceutical distribution centers. It focuses on assessing serialization equipment, data management systems, packaging line operations, and compliance with regulatory requirements such as the Drug Supply Chain Security Act (DSCSA). By thoroughly examining these critical aspects, this checklist helps identify potential vulnerabilities, improve supply chain visibility, and ensure regulatory compliance. Regular audits of serialization and track-and-trace systems are essential for maintaining product integrity, enhancing patient safety, and supporting the secure distribution of pharmaceutical products.

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Industry

Healthcare

Standard

Pharmaceutical Supply Chain Security Standards

Workspaces

Distribution Centers

Occupations

Serialization Managers
Quality Assurance Specialists
IT Systems Administrators
Packaging Line Supervisors
Regulatory Compliance Officers
1
Is the product authentication process compliant with the DSCSA and FMD regulations?
2
What is the accuracy percentage of the serialization equipment used?
Min: 90
Target: 99
Max: 100
3
Is the data management system for track-and-trace operations reliable?
4
Are the packaging line operations compliant with serialization requirements?
5
Are the supply chain security measures in place and effective?
6
What strategies are in place to prevent counterfeit products in the supply chain?
7
What is the average response time to incidents related to counterfeit products?
Min: 0
Target: 24
Max: 48
8
Have employees received training on counterfeit prevention?
9
Is the serialization equipment calibrated and validated for accuracy?
10
Is there complete documentation for the serialization process?
11
What is the error rate observed in the serialization process?
Min: 0
Target: 1
Max: 5
12
Is the serialization process compliant with all relevant regulations?
13
What is the assessed risk level associated with the serialization process?
14
What mitigation strategies are implemented to address identified risks?
15
How often are risk assessments conducted for the serialization process?
Min: 1
Target: 6
Max: 12
16
Are employees aware of the risks associated with the serialization process?
17
What is the total downtime of the serialization system in the past month?
Min: 0
Target: 2
Max: 24
18
How would you rate the overall performance of the serialization system?
19
How frequently is the serialization system updated or maintained?
20
Are there backup procedures in place for the serialization data?

FAQs

Key components include serialization equipment (e.g., printers, vision systems), data management software, secure data exchange platforms, aggregation processes, and integration with warehouse management systems.

Comprehensive audits should be conducted at least annually, with more frequent checks on critical system components and data integrity. Additional audits may be necessary after system upgrades or regulatory changes.

The audit team should include IT specialists, quality assurance professionals, packaging line managers, regulatory affairs experts, and potentially external consultants with expertise in pharmaceutical serialization requirements.

Key documentation includes standard operating procedures (SOPs) for serialization processes, system validation reports, data integrity checks, employee training records, change control logs, and records of serialization data exchange with trading partners.

By systematically evaluating serialization and track-and-trace processes, the checklist helps identify gaps in data management, improve serialization accuracy, enhance system integration, and ensure compliance with regulatory requirements. This leads to better supply chain security, improved recall readiness, and enhanced patient safety.

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

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

Improves supply chain security and reduces the risk of counterfeit products

Enhances recall efficiency and effectiveness

Increases supply chain visibility and inventory management accuracy

Supports patient safety through improved product authentication