Standard Operating Procedure for Cleaning and Sanitization of Quarantine Storage Units

Department	Warehouse / Quality Assurance / Maintenance
SOP No.	SOP/RM/068/2025
Supersedes	SOP/RM/068/2022
Page No.	Page 1 of 15
Issue Date	01/02/2025
Effective Date	05/02/2025
Review Date	01/02/2026

1. Purpose

This Standard Operating Procedure (SOP) outlines the process for cleaning and sanitizing quarantine storage units to prevent contamination of raw materials and ensure compliance with Good Manufacturing Practices (GMP).

2. Scope

This SOP applies to all storage units, including racks, shelves, pallets, and containers, used for storing raw materials in the quarantine area before Quality Control (QC) testing and Quality Assurance (QA) approval.

3. Responsibilities

• Warehouse Personnel: Perform cleaning and sanitization activities according to this SOP and document all procedures.
• Quality Assurance (QA): Review and approve cleaning procedures, monitor compliance, and verify records.
• Maintenance Personnel: Ensure cleaning equipment is functional and properly maintained.

4. Accountability

The Warehouse Manager is responsible for ensuring proper cleaning and sanitization of quarantine storage units. The QA Manager verifies compliance with GMP standards, and the Maintenance Manager ensures that cleaning equipment is in good working condition.

5. Procedure

5.1 Preparation for Cleaning and Sanitization

1. Personnel Preparation:
   • Ensure all personnel involved in cleaning are trained in this SOP and proper use of cleaning agents.
   • Personnel must wear appropriate Personal Protective Equipment (PPE), including gloves, masks, goggles, and lab coats.
2. Equipment and Cleaning Agents:
   • Gather necessary cleaning tools such as mops, brushes, cleaning cloths, vacuum cleaners, and sanitizing agents.
   • Ensure cleaning agents are approved for use in the storage area and do not leave residues that could contaminate materials.
   • Document the use of cleaning agents in the Cleaning Agent Usage Log (Annexure-1).

5.2 Cleaning Procedure for Quarantine Storage Units

1. General Cleaning:
   • Remove all raw materials from the storage units before cleaning. Ensure materials are properly labeled and stored in a temporary, contamination-free area.
   • Dust and vacuum shelves, racks, and pallets to remove loose dirt and debris.
   • Wipe down all surfaces with a damp cloth soaked in approved cleaning solution. Pay special attention to corners and crevices where dust may accumulate.
2. Sanitization:
   • Apply sanitizing agents to all cleaned surfaces using spray bottles or sanitizing wipes.
   • Allow surfaces to air dry or use disposable cloths to wipe dry, ensuring no lint or residues remain.
   • Document cleaning and sanitization activities in the Quarantine Cleaning Log (Annexure-2).

5.3 Frequency and Scheduling of Cleaning

1. Routine Cleaning:
   • Perform general cleaning and sanitization of storage units weekly.
   • Document routine cleaning schedules in the Cleaning Schedule Log (Annexure-3).
2. Deep Cleaning:
   • Conduct deep cleaning monthly or after any contamination incident.
   • Deep cleaning involves disassembling shelving units (if applicable) and cleaning all parts thoroughly.

5.4 Handling Deviations and Contamination Incidents

1. Identification of Deviations:
   • Any deviations from cleaning schedules or procedures must be reported to QA immediately.
   • Document deviations in the Cleaning Deviation Report (Annexure-4).
2. Contamination Response:
   • If contamination is detected, quarantine the affected area and remove any potentially compromised materials.
   • Perform immediate deep cleaning and sanitization, and document actions in the Contamination Incident Report (Annexure-5).

6. Abbreviations

• SOP: Standard Operating Procedure
• GMP: Good Manufacturing Practice
• QA: Quality Assurance
• PPE: Personal Protective Equipment

7. Documents

1. Cleaning Agent Usage Log (Annexure-1)
2. Quarantine Cleaning Log (Annexure-2)
3. Cleaning Schedule Log (Annexure-3)
4. Cleaning Deviation Report (Annexure-4)
5. Contamination Incident Report (Annexure-5)

8. References

• 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals
• ICH Q7 – Good Manufacturing Practice for Active Pharmaceutical Ingredients
• EU Guidelines on Good Distribution Practices (GDP)

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Cleaning Agent Usage Log

Date	Cleaning Agent Used	Batch Number	Applied By	Verified By (QA)	Remarks
01/02/2025	Sanitize-X	SX-2025-001	Ravi Kumar	Anjali Mehta	No Residue Left
01/02/2025	Disinfect-Y	DY-2025-002	Sunita Sharma	Ajay Singh	Properly Applied

Annexure-2: Quarantine Cleaning Log

Date	Storage Unit	Cleaned By	Verified By (QA)	Remarks
01/02/2025	Shelf A1	Ravi Kumar	Anjali Mehta	Clean and Sanitized
01/02/2025	Pallet B2	Sunita Sharma	Ajay Singh	No Issues

Annexure-3: Cleaning Schedule Log

Week	Scheduled Cleaning Date	Performed By	Verified By (QA)	Status
Week 1	01/02/2025	Ravi Kumar	Anjali Mehta	Completed
Week 2	08/02/2025	Sunita Sharma	Ajay Singh	Pending

Annexure-4: Cleaning Deviation Report

Date	Deviation Description	Reported By	Corrective Action Taken	Verified By (QA)
02/02/2025	Missed Cleaning Schedule	Ravi Kumar	Rescheduled and Completed	Anjali Mehta

Annexure-5: Contamination Incident Report

Date	Incident Description	Reported By	Immediate Action Taken	Follow-Up Action	Verified By (QA)
03/02/2025	Dust Contamination Detected on Shelf A1	Sunita Sharma	Shelf Quarantined and Cleaned	Routine Monitoring Increased	Ajay Singh

Revision History:

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
01/01/2024	1.0	Initial Version	New SOP	QA Head
01/02/2025	2.0	Updated Cleaning Procedures and Documentation Formats	Regulatory Compliance	QA Head