Standard Operating Procedure for Handling Expired Raw Materials in API Manufacturing

Department	API Manufacturing
SOP No.	SOP/API/012/2025
Supersedes	SOP/API/012/2022
Page No.	Page 1 of 10
Issue Date	13/04/2025
Effective Date	15/04/2025
Review Date	13/04/2026

1. Purpose

To describe the systematic procedure for identification, segregation, recording, evaluation, and disposal of expired raw materials in order to prevent their unintentional use in production and ensure GMP compliance in API manufacturing.

2. Scope

This SOP applies to all raw materials (APIs, excipients, solvents, reagents) stored in the warehouse that have exceeded their manufacturer-defined expiry or retest date.

3. Responsibilities

• Warehouse Staff: Monitor expiry dates, segregate expired materials, label and record details.
• QA Officer: Review expired material records, authorize disposal or re-evaluation.
• EHS Officer: Ensure proper disposal in accordance with environmental regulations.

4. Accountability

The QA Manager and Warehouse Manager are jointly accountable for the compliant and safe handling of expired raw materials.

5. Procedure

5.1 Identification of Expired Materials

1. Warehouse staff shall conduct a monthly review of all stored raw materials using the “Material Expiry Monitoring Register” (Annexure-1).
2. Materials nearing expiry within 30 days should be flagged and reviewed for possible accelerated use or disposal.
3. Materials that have crossed expiry/retest date shall be labeled “EXPIRED – DO NOT USE.”

5.2 Segregation of Expired Materials

1. Immediately transfer expired materials to a designated “Expired Material Quarantine Area.”
2. Ensure the area is physically separated and marked with “RESTRICTED ACCESS – EXPIRED MATERIALS.”
3. Update storage location in the inventory control system.

5.3 Documentation

1. Log each expired item in the “Expired Material Log” (Annexure-2) with:
   • Material Name
   • Batch No.
   • Manufacturer
   • Expiry Date
   • Date Identified
   • Quantity
2. Prepare the “Expired Material Evaluation Form” (Annexure-3) for QA review.

5.4 Evaluation and Final Disposition

1. QA evaluates whether the expired material can be:
   • Sent for re-analysis (if retest date is defined)
   • Destroyed (if no retest date or failed re-evaluation)
2. If destroyed, coordinate with the EHS department for safe disposal via approved vendors.
3. Complete “Material Disposal Record” and retain for audit purposes.

5.5 Preventive Measures

1. Implement FEFO-based storage to avoid expiry-related wastage.
2. Train warehouse personnel in shelf-life management practices.

6. Abbreviations

• SOP: Standard Operating Procedure
• QA: Quality Assurance
• EHS: Environment, Health & Safety
• FEFO: First Expiry, First Out

7. Documents

1. Material Expiry Monitoring Register (Annexure-1)
2. Expired Material Log (Annexure-2)
3. Expired Material Evaluation Form (Annexure-3)

8. References

• ICH Q7 – GMP Guidelines for Active Pharmaceutical Ingredients
• 21 CFR Part 211.192 – Production record review
• WHO TRS 986 Annex 2 – GMP for warehouse operations

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Designation	Warehouse Executive	QA Officer	QA Manager
Department	API Manufacturing	Quality Assurance	Quality Assurance

11. Annexures

Annexure-1: Material Expiry Monitoring Register

Date	Material	Batch No.	Expiry Date	Status	Remarks
13/04/2025	Citric Acid	CA202402	31/03/2025	Expired	Moved to Expired Area

Annexure-2: Expired Material Log

Date	Material	Batch	Qty	Identified By	Action
13/04/2025	Citric Acid	CA202402	25 kg	Warehouse Staff	Sent for disposal

Annexure-3: Expired Material Evaluation Form

Material	Batch	Expiry Date	Retest Option	QA Recommendation	Disposition
Citric Acid	CA202402	31/03/2025	Not Applicable	Dispose	Incineration

Revision History:

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
01/01/2022	1.0	Initial Version	Regulatory Compliance	QA Head
13/04/2025	2.0	Included Evaluation Form and Quarantine Area Segregation	GMP Update	QA Head