Standard Operating Procedure for Handling of Counterfeit Products

Purpose

The purpose of this SOP is to establish procedures for the identification, quarantine, and reporting of counterfeit products within the pharmaceutical distribution facility, ensuring compliance with regulatory requirements and safeguarding patient safety and product integrity.

Scope

This SOP applies to all personnel involved in the receipt, storage, handling, and distribution of pharmaceutical products within the facility, as well as those responsible for quality assurance and regulatory compliance.

Responsibilities

• The Quality Assurance Manager is responsible for overseeing procedures related to the identification and handling of counterfeit products and ensuring compliance with regulatory requirements.
• The Warehouse Supervisor is responsible for monitoring incoming shipments for signs of counterfeit products and taking appropriate action if counterfeit products are identified.
• All personnel are responsible for adhering to procedures outlined in this SOP and reporting any suspected counterfeit products to the Quality Assurance Manager or Warehouse Supervisor.

Procedure

1. Identification of Counterfeit Products:
   • Train personnel on the identification of counterfeit products, including common signs of counterfeiting such as suspicious packaging, labeling discrepancies, and unusual appearance or markings.
   • Implement procedures for inspecting incoming shipments for signs of counterfeiting, including verification of product authenticity through available resources such as manufacturer databases or authentication technologies.
2. Quarantine and Segregation:
   • If counterfeit products are suspected or identified, quarantine the products immediately to prevent distribution or use.
   • Segregate counterfeit products from genuine products to avoid mixing or accidental distribution.
3. Notification and Reporting:
   • Notify the relevant authorities, such as regulatory agencies and law enforcement, immediately upon identification of counterfeit products.
   • Document all relevant information regarding the suspected counterfeit products, including product details, quantity, supplier information, and any supporting evidence.
4. Investigation and Disposition:
   • Conduct a thorough investigation into the suspected counterfeit products to determine the source and extent of the counterfeiting activity.
   • Collaborate with regulatory authorities and other stakeholders to coordinate actions for disposition of counterfeit products, including disposal or return to the supplier.
5. Training and Awareness:
   • Provide regular training to personnel on procedures for identifying and handling counterfeit products and the importance of reporting suspicious activities.
   • Ensure that personnel are aware of the potential risks associated with counterfeit products and understand their role in preventing their distribution.

Abbreviations

• SOP – Standard Operating Procedure

Documents

Reference documents related to handling of counterfeit products may include:

• Counterfeit product identification guidelines
• Incident reports
• Regulatory notifications
• Investigation findings
• Training records

Reference

Good Distribution Practice Guidelines

SOP Version

Version 1.0