Standard Operating Procedure for Product Serialization and Track & Trace

Purpose

The purpose of this SOP is to establish procedures for the implementation and management of product serialization and track & trace systems within the pharmaceutical distribution facility, ensuring compliance with regulatory requirements and enhancing supply chain visibility and security.

Scope

This SOP applies to all personnel involved in the implementation, operation, and maintenance of product serialization and track & trace systems, including IT professionals, quality assurance personnel, and supply chain managers.

Responsibilities

• The IT Manager is responsible for overseeing the implementation and maintenance of product serialization and track & trace systems, including system configuration, data management, and technical support.
• The Quality Assurance Manager is responsible for ensuring that product serialization and track & trace systems comply with regulatory requirements, quality standards, and company policies.
• All personnel involved in product serialization and track & trace activities are responsible for adhering to procedures outlined in this SOP and reporting any issues or deviations to the appropriate authorities.

Procedure

1. System Implementation:
   • Select and implement a product serialization and track & trace system that meets regulatory requirements and company needs, considering factors such as scalability, compatibility, and functionality.
   • Configure the system to generate unique serial numbers or identifiers for individual product units and establish data capture and storage mechanisms for track & trace purposes.
2. Data Management:
   • Establish procedures for capturing, recording, and managing serialization data throughout the product lifecycle, including data entry, validation, storage, and retrieval.
   • Ensure the accuracy, integrity, and security of serialization data by implementing appropriate data validation checks, encryption methods, and access controls.
3. Product Labeling:
   • Incorporate serialized product identifiers into product labels or packaging according to regulatory requirements, ensuring that labels are legible, tamper-evident, and compliant with industry standards.
   • Verify label accuracy and readability before product distribution, checking for any printing errors or discrepancies in serialized data.
4. Track & Trace Operations:
   • Utilize the track & trace system to capture and record product movement and transaction data at each stage of the supply chain, including manufacturing, distribution, and dispensing.
   • Enable real-time monitoring and reporting of product locations, status, and chain of custody information to facilitate timely response to supply chain events and regulatory inquiries.
5. Regulatory Compliance:
   • Ensure that product serialization and track & trace systems comply with all relevant regulatory requirements, including those outlined by regulatory authorities such as the FDA, EMA, and WHO.
   • Maintain documentation and records of system validation, configuration changes, and regulatory submissions to demonstrate compliance with regulatory standards.

Abbreviations

• SOP – Standard Operating Procedure
• IT – Information Technology
• FDA – U.S. Food and Drug Administration
• EMA – European Medicines Agency
• WHO – World Health Organization

Documents

Reference documents related to product serialization and track & trace may include:

• System implementation plans
• Data management procedures
• Product labeling guidelines
• Track & trace operation manuals
• Regulatory guidelines on serialization and track & trace

Reference

Good Distribution Practice Guidelines

SOP Version

Version 1.0