Handling of Expired Materials – Standard Operating Procedure

1) Purpose

To establish guidelines for the identification, segregation, handling, and disposal of expired materials to prevent their use in manufacturing processes, ensure product quality and compliance within the pharmaceutical manufacturing department.

2) Scope

This SOP applies to all expired materials, including raw materials, packaging materials, and finished goods, used in pharmaceutical manufacturing and distribution.

3) Responsibilities

Quality Assurance Team: Responsible for overseeing the handling and disposal of expired materials.
Warehouse Manager: Responsible for identifying and segregating expired materials in inventory.

4) Procedure

4.1) Identification of Expired Materials:
4.1.1) Regularly inspect inventory for expired materials based on expiration dates and shelf life.
4.1.2) Clearly label expired materials and segregate them from usable inventory.

4.2) Segregation and Quarantine:
4.2.1) Segregate expired materials in designated quarantine areas to prevent accidental use.
4.2.2) Ensure quarantine areas are secure and access is restricted to authorized personnel.

4.3) Disposition Decision:
4.3.1) Determine disposition options for expired materials, such as destruction, return to supplier, or retesting.
4.3.2) Evaluate material condition and regulatory requirements when making disposition decisions.

4.4) Disposal Procedures:
4.4.1) Dispose of expired materials in compliance with environmental regulations and company policies.
4.4.2) Document disposal activities, including method used and disposal certificates if applicable.

4.5) Documentation and Reporting:
4.5.1) Maintain accurate records of expired materials, including identification, segregation, and disposal details.
4.5.2) Report on expired materials management activities to management and regulatory authorities as required.

5) Abbreviations, if any

N/A

6) Documents, if any

• Expired Materials Log
• Quarantine Area Logs
• Disposal Certificates
• Management Reports on Expired Materials

7) Reference, if any

Regulatory Guidelines: FDA CFR Part 211.137, ICH Q7
Industry Standards: ISO 9001:2015

8) SOP Version

Version 1.0