Standard Operating Procedure for Expiry Management

Purpose

The purpose of this SOP is to establish procedures for managing and disposing of expired pharmaceutical products in the warehouse to ensure compliance with regulatory requirements and prevent the distribution of unsafe or ineffective products.

Scope

This SOP applies to all personnel involved in inventory management, quality control, and warehouse operations within the pharmaceutical facility.

Responsibilities

• Warehouse Manager: Overall responsibility for implementing expiry management procedures and ensuring compliance.
• Quality Assurance: Responsible for identifying and assessing expired products and initiating disposal procedures.
• Inventory Managers: Responsible for monitoring expiration dates and coordinating disposal activities.
• Warehouse Staff: Responsible for segregating expired products and facilitating their disposal in accordance with SOP.

Procedure

1. Expiration Date Monitoring:
   • Regularly monitor expiration dates of pharmaceutical products in inventory using inventory management systems or manual checks.
   • Establish clear criteria for identifying expired products, including expiration date thresholds and visual inspection.
   • Segregate expired products from active inventory to prevent accidental distribution or use.
2. Disposal Authorization:
   • Notify relevant personnel, including quality assurance and management, of the identification of expired products.
   • Obtain authorization for the disposal of expired products in accordance with established procedures and regulatory requirements.
   • Document the authorization process and maintain records of expired product identification and disposal.
3. Disposal Procedures:
   • Follow approved disposal methods for pharmaceutical products, which may include incineration, landfill disposal, or other appropriate methods.
   • Coordinate with authorized disposal vendors or waste management companies to arrange for the safe and compliant disposal of expired products.
   • Ensure that disposal activities are conducted in accordance with applicable regulations and environmental standards.
4. Documentation and Reporting:
   • Maintain accurate records of expired product identification, authorization for disposal, and disposal activities.
   • Document disposal certificates or records provided by disposal vendors as proof of compliant disposal.
   • Report on expiry management activities, including trends, disposal volumes, and any incidents or deviations, to relevant stakeholders.

Abbreviations

• SOP: Standard Operating Procedure

Documents

• Expired Product Log
• Disposal Authorization Forms
• Disposal Certificates
• Expiry Management Reports

SOP Version

Version 1.0