Standard Operating Procedure for Management of Expiry and Shelf-life

Purpose

The purpose of this SOP is to establish procedures for the effective management of expiry dates and shelf-life of pharmaceutical products within the distribution facility, ensuring compliance with regulatory requirements and maintaining product quality and integrity.

Scope

This SOP applies to all personnel involved in the receipt, storage, handling, and distribution of pharmaceutical products within the facility.

Responsibilities

• The Quality Assurance Manager is responsible for overseeing the implementation of procedures related to expiry and shelf-life management and ensuring compliance with regulatory requirements.
• The Warehouse Supervisor is responsible for monitoring expiry dates and shelf-life of products in storage and ensuring that products are rotated appropriately to minimize expiry-related risks.
• All personnel are responsible for adhering to procedures outlined in this SOP and reporting any issues or discrepancies related to expiry and shelf-life management to the Quality Assurance Manager or Warehouse Supervisor.

Procedure

1. Receipt and Inspection:
   • Upon receipt of pharmaceutical products, inspect packaging and labeling for expiry dates and shelf-life information.
   • Record expiry dates and shelf-life information in inventory management systems or designated records.
2. Storage and Handling:
   • Store products in accordance with manufacturer instructions and storage requirements specified on product labels.
   • Ensure that products with the shortest shelf-life are placed in storage areas where they will be accessed and used first (first-in, first-out principle).
3. Monitoring and Rotation:
   • Regularly monitor expiry dates and shelf-life of products in storage using inventory management systems or manual checks.
   • Rotate stock as necessary to ensure that products with impending expiry dates are used or disposed of before expiry.
4. Expiry Management:
   • Implement procedures for managing products that have expired or are nearing expiry, including segregation, quarantine, and disposal.
   • Document expiry-related actions taken, including product disposition and disposal methods.
5. Training and Awareness:
   • Provide training to personnel on the importance of expiry and shelf-life management and the procedures outlined in this SOP.
   • Ensure that personnel are aware of their roles and responsibilities regarding expiry and shelf-life management and understand the consequences of non-compliance.

Abbreviations

• SOP – Standard Operating Procedure

Documents

Reference documents related to expiry and shelf-life management may include:

• Product labels and packaging
• Inventory records
• Expiry management procedures
• Training records
• Disposal records

Reference

Good Distribution Practice Guidelines

SOP Version

Version 1.0