Standard Operating Procedure for Destruction of Expired or Rejected Products

Purpose

The purpose of this SOP is to establish procedures for the safe and compliant destruction of expired or rejected pharmaceutical products within the distribution facility, ensuring proper disposal to prevent unauthorized use or resale.

Scope

This SOP applies to all personnel involved in the identification, segregation, handling, and destruction of expired or rejected pharmaceutical products, including warehouse personnel, quality assurance professionals, and disposal contractors.

Responsibilities

• The Warehouse Supervisor is responsible for overseeing the destruction process and ensuring compliance with regulatory requirements and company policies.
• The Quality Assurance Manager is responsible for verifying the authenticity of expired or rejected products and approving their destruction in accordance with established procedures.
• All personnel involved in the destruction process are responsible for following procedures outlined in this SOP and adhering to safety protocols to prevent accidents or environmental contamination.

Procedure

1. Identification and Segregation:
   • Identify expired or rejected products through regular inventory checks, quality inspections, or product returns, and segregate them from sale-able inventory to prevent unintended distribution.
   • Label expired or rejected products with appropriate markings or tags to indicate their status and prevent accidental inclusion in distribution or use.
2. Destruction Authorization:
   • Obtain authorization from the Quality Assurance Manager or designated personnel before initiating the destruction of expired or rejected products, ensuring that all necessary approvals and documentation are in place.
   • Verify the accuracy and completeness of destruction authorization documents, including product details, quantities, and destruction methods, before proceeding with disposal.
3. Destruction Process:
   • Follow established procedures for the safe and compliant destruction of expired or rejected products, utilizing approved methods such as incineration, shredding, or chemical decomposition.
   • Ensure that destruction activities are conducted in a secure and controlled environment to prevent unauthorized access or tampering with the disposal process.
4. Documentation and Record keeping:
   • Document all destruction activities, including product identification, destruction methods used, quantities destroyed, and personnel involved in the process.
   • Maintain accurate and complete records of destruction documentation, including destruction certificates, manifests, and disposal receipts, for regulatory compliance and audit purposes.
5. Post-Destruction Verification:
   • Verify the completion and effectiveness of destruction activities through post-destruction inspections or audits, ensuring that all expired or rejected products have been properly disposed of and cannot be recovered or reused.
   • Address any discrepancies or issues identified during post-destruction verification and implement corrective actions as necessary to prevent recurrence.

Abbreviations

• SOP – Standard Operating Procedure

Documents

Reference documents related to the destruction of expired or rejected products may include:

• Destruction authorization forms
• Destruction certificates
• Disposal manifests
• Post-destruction verification reports
• Regulatory guidelines on product disposal

Reference

Good Distribution Practice Guidelines

SOP Version

Version 1.0