Handling Expired Materials – Standard Operating Procedure

1) Purpose

To establish a standardized process for handling expired materials to ensure compliance with regulatory requirements and prevent the use of expired materials in production within the pharmaceutical purchase department.

2) Scope

This SOP applies to all materials, including raw materials, packaging materials, and finished goods, that have exceeded their expiration date within the pharmaceutical purchase department.

3) Responsibilities

Quality Assurance (QA) Manager: Responsible for overseeing the handling and disposition of expired materials.
Inventory Manager: Responsible for identifying expired materials and coordinating their removal from inventory.
Production Team: Responsible for ensuring that expired materials are not used in production processes.

4) Procedure

4.1) Identification of Expired Materials:
4.1.1) Regularly review inventory records to identify materials approaching or exceeding their expiration date.
4.1.2) Use inventory management systems to generate alerts for materials nearing expiration.

4.2) Segregation of Expired Materials:
4.2.1) Immediately segregate expired materials from active inventory to prevent accidental use.
4.2.2) Clearly label segregated materials as “Expired” and move them to a designated quarantine area.

4.3) Documentation and Reporting:
4.3.1) Document the details of expired materials, including material name, batch number, expiration date, and quantity.
4.3.2) Report the identified expired materials to the QA Manager for further action.

4.4) Disposition of Expired Materials:
4.4.1) Determine the appropriate method of disposition for expired materials, such as destruction, return to supplier, or rework (if applicable and safe).
4.4.2) Obtain necessary approvals for the chosen method of disposition.
4.4.3) Ensure that the disposition process is carried out in compliance with regulatory requirements and environmental guidelines.

4.5) Record Keeping:
4.5.1) Maintain detailed records of expired materials, including disposition method, approvals, and final disposition actions.
4.5.2) Ensure documentation is complete, accurate, and readily available for audits and future reference.

4.6) Preventive Measures:
4.6.1) Implement inventory management practices to minimize the occurrence of expired materials.
4.6.2) Monitor stock levels and adjust procurement practices to align with actual usage rates and minimize overstocking.

5) Abbreviations, if any

• QA: Quality Assurance

6) Documents, if any

• Inventory Records
• Expired Materials Log
• Disposition Approval Forms
• Disposition Records

7) Reference, if any

Regulatory Guidelines: FDA CFR Part 211, GMP Guidelines
Industry Standards: Best practices in material management and disposal

8) SOP Version

Version 1.0