Standard Operating Procedure for Serialization and Traceability

1) Purpose

This SOP outlines the procedures for implementing serialization and traceability systems for pharmaceutical products to comply with regulatory requirements, prevent counterfeit products, and enhance supply chain visibility.

2) Scope

This SOP applies to all pharmaceutical products subject to serialization requirements, including prescription drugs, over-the-counter medications, and biologics.

3) Responsibilities

The Serialization Manager or designated personnel are responsible for overseeing serialization and traceability activities. Production, quality control, packaging, logistics, and IT departments are responsible for implementing procedures outlined in this SOP.

4) Procedure

4.1 Serialization Implementation

1. Assess regulatory requirements and establish a serialization strategy based on global and local regulations (e.g., FDA DSCSA, EU FMD).
2. Implement serialization infrastructure, including hardware (e.g., serialization printers, barcode scanners) and software (e.g., serialization software, track-and-trace systems).

4.2 Data Management

1. Generate and manage unique serial numbers and associated product data in accordance with regulatory guidelines and company policies.
2. Integrate serialization data with enterprise resource planning (ERP) systems and electronic batch records (EBR) for seamless data exchange.

4.3 Printing and Application

1. Ensure accurate printing and application of serialized codes on primary packaging (e.g., labels, blister packs) and secondary packaging (e.g., cartons).
2. Verify the readability and integrity of serialized data throughout the packaging process.

4.4 Aggregation (if applicable)

1. Implement aggregation processes to link individual product units with higher-level packaging (e.g., cases, pallets) for enhanced traceability.
2. Verify aggregation accuracy and completeness to facilitate efficient tracking and recall management.

4.5 Data Reporting and Exchange

1. Generate and transmit serialization data to regulatory authorities, trading partners, and supply chain stakeholders as required by applicable regulations.
2. Ensure compliance with data exchange standards (e.g., GS1 EPCIS) and interoperability with external serialization systems.

4.6 Verification and Decommissioning

1. Implement verification processes to ensure the authenticity and validity of serialized codes at various points in the supply chain.
2. Facilitate product decommissioning and reporting for recalled, expired, or otherwise non-compliant products as per regulatory requirements.

5) Abbreviations, if any

SOP: Standard Operating Procedure
DSCSA: Drug Supply Chain Security Act
FMD: Falsified Medicines Directive
ERP: Enterprise Resource Planning
EBR: Electronic Batch Record
GS1 EPCIS: GS1 Electronic Product Code Information Services

6) Documents, if any

Serialization Plans, Data Management Protocols, Verification Reports, Aggregation Records, Decommissioning Logs

7) Reference, if any

Regulatory guidelines and requirements for serialization and traceability, including FDA DSCSA regulations, EU FMD directives, and industry best practices for pharmaceutical serialization.

8) SOP Version

Version 1.0