raw materials, gel bases, intermediates, and finished products.

3. Responsibilities

• Warehouse Executive: Identifies and segregates expired items.
• Production Supervisor: Confirms expiration and ensures proper handover for disposal.
• Quality Assurance: Approves and documents the disposal process.
• EHS Officer: Ensures environmentally safe disposal procedures.

4. Accountability

Department Head – Gel Manufacturing and Head – Quality Assurance

5. Procedure

5.1 Identification and Segregation

1. Warehouse team to conduct monthly reviews of expiry dates of raw materials and finished goods.
2. Items reaching expiry shall be tagged as “Expired – Not for Use” with red labels.
3. Move expired items to designated “Quarantine for Disposal” storage area.

5.2 Documentation and Approval

1. Fill out the Expired Material Disposal Request Form (Annexure-1).
2. QA to review and approve the request form before disposal activity begins.
3. Each disposal must be assigned a unique reference number for traceability.

5.3 Disposal Methods

1. Solid Raw Materials: Sent for incineration or landfilling via approved vendors.
2. Liquid Gel Bases: Neutralized and drained per local effluent guidelines.
3. Intermediate/Finished Gels: Blended with inert material and incinerated.
4. Disposal must be witnessed by QA and EHS personnel.

5.4 Records and Logs

1. Maintain a Disposal Register with product name, batch number, expiry date, and method used.
2. Attach certificate of disposal from vendor to the respective batch file.

5.5 Vendor Management

1. Only pollution control board-approved vendors shall be used for hazardous waste disposal.
2. Annual audits of vendors’ disposal sites must be carried out.

5.6 Deviation Handling

1. If disposal is delayed or improperly done, a deviation form must be raised and reviewed by QA.
2. Corrective and Preventive Actions (CAPA) to be defined and tracked.

6. Abbreviations

• QA: Quality Assurance
• EHS: Environment, Health, and Safety
• CAPA: Corrective and Preventive Action

7. Documents

1. Expired Material Disposal Request Form – Annexure-1
2. Disposal Register – Annexure-2
3. Certificate of Disposal – Annexure-3

8. References

• WHO TRS 986 Annex 2: GMP for Pharmaceutical Products
• Pollution Control Board Guidelines

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation	Jr. Production Chemist	QA Executive	Head – Manufacturing
Department	Gel Manufacturing	Quality Assurance	Manufacturing

11. Annexures

Annexure-1: Expired Material Disposal Request Form

Product/Material Name
Batch No.
Quantity
Expiry Date
Reason for Disposal	Expired
Requested By
Approved By (QA)

Annexure-2: Disposal Register

Entry No.	Date	Material	Batch	Qty	Disposal Method	Witness (QA)
001

Annexure-3: Certificate of Disposal

To be provided by the approved external waste management agency and attached to batch record.

Revision History

Revision Date	Revision No.	Change Description	Reason	Approved By
15/03/2022	1.0	Initial release	New SOP	QA Head
09/06/2025	2.0	Added vendor compliance and deviation handling	Annual revision	QA Head