Standard Operating Procedure for Product Authentication

Purpose

The purpose of this SOP is to establish procedures for the authentication of pharmaceutical products within the distribution facility, ensuring that products are genuine, safe, and compliant with regulatory requirements.

Scope

This SOP applies to all personnel involved in the receipt, storage, handling, and distribution of pharmaceutical products, as well as those responsible for product authentication procedures.

Responsibilities

• The Quality Assurance Manager is responsible for overseeing product authentication activities and ensuring compliance with regulatory requirements and company standards.
• The Warehouse Supervisor is responsible for verifying product authenticity during receipt, storage, and distribution processes and reporting any suspicions or concerns to the Quality Assurance Manager.
• All personnel are responsible for following procedures outlined in this SOP and adhering to established protocols for product authentication.

Procedure

1. Authentication Methods:
   • Establish authentication methods and procedures for verifying the authenticity of pharmaceutical products, such as visual inspection, packaging checks, and use of authentication technologies.
   • Train personnel on authentication techniques and recognition of potential counterfeit or falsified products, including identification of suspicious packaging, labeling, or product characteristics.
2. Product Inspection:
   • Inspect incoming products for signs of tampering, damage, or discrepancies in packaging, labeling, or product appearance that may indicate potential counterfeiting or falsification.
   • Verify product authenticity by comparing packaging features, labeling information, batch numbers, and other product identifiers against reference materials or databases.
3. Authentication Technologies:
   • Utilize authentication technologies, such as barcode scanning, RFID (Radio-Frequency Identification), holograms, or serialization systems, to verify product authenticity and track product movement throughout the supply chain.
   • Implement and maintain authentication systems and equipment in accordance with manufacturer instructions and regulatory requirements.
4. Documentation and Reporting:
   • Document product authentication activities, including results of inspections, authentication checks, and any suspected or confirmed cases of counterfeit or falsified products.
   • Report any suspicions or incidents of counterfeit products to the appropriate authorities and follow established procedures for product quarantine, investigation, and disposition.
5. Continuous Improvement:
   • Review and evaluate product authentication procedures periodically to identify opportunities for improvement and enhance detection capabilities.
   • Implement corrective actions and preventive measures based on lessons learned from authentication activities and emerging threats in the counterfeit market.

Abbreviations

• SOP – Standard Operating Procedure
• RFID – Radio-Frequency Identification

Documents

Reference documents related to product authentication may include:

• Product authentication procedures
• Training materials on counterfeit detection
• Authentication technology specifications
• Incident reports on suspected counterfeit products
• Regulatory guidelines on product authentication

Reference

Good Distribution Practice Guidelines

SOP Version

Version 1.0