Standard Operating Procedure for Managing Temperature-Controlled Zones in Warehouses

Department	Warehouse / Quality Assurance / Maintenance
SOP No.	SOP/RM/189/2025
Supersedes	SOP/RM/189/2022
Page No.	Page 1 of 15
Issue Date	24/04/2025
Effective Date	01/05/2025
Review Date	24/04/2026

1. Purpose

This Standard Operating Procedure (SOP) provides guidelines for the management, monitoring, and maintenance of temperature-controlled zones in warehouses to ensure the integrity of temperature-sensitive raw materials.

2. Scope

This SOP applies to all warehouse personnel involved in the storage, monitoring, and handling of temperature-sensitive raw materials in designated temperature-controlled zones.

3. Responsibilities

• Warehouse Personnel: Ensure materials are stored in appropriate temperature-controlled zones and monitor conditions regularly.
• Quality Assurance (QA) Team: Conduct audits and ensure compliance with storage conditions and Good Manufacturing Practices (GMP).
• Maintenance Team: Perform regular maintenance and calibration of temperature control equipment.

4. Accountability

The Warehouse Manager is accountable for maintaining proper temperature conditions. The QA Manager ensures compliance with GMP storage guidelines, and the Maintenance Manager is responsible for equipment calibration and upkeep.

5. Procedure

5.1 Setup and Maintenance of Temperature-Controlled Zones

1. Zone Designation:
   • Designate specific areas for cold storage (2-8°C), controlled room temperature (15-25°C), and frozen storage (-20°C).
   • Document zone setup in the Temperature-Controlled Zone Setup Log (Annexure-1).
2. Equipment Maintenance:
   • Ensure regular maintenance and servicing of HVAC systems, refrigerators, and freezers.
   • Record maintenance activities in the Equipment Maintenance Log (Annexure-2).

5.2 Monitoring Temperature and Humidity

1. Temperature Monitoring Devices:
   • Install temperature and humidity monitoring devices with alarms for deviations.
   • Document device installation in the Monitoring Device Installation Log (Annexure-3).
2. Daily Monitoring:
   • Record temperature and humidity readings twice daily to ensure compliance with specified limits.
   • Log readings in the Temperature and Humidity Monitoring Log (Annexure-4).

5.3 Handling Temperature Excursions

1. Deviation Identification:
   • Immediately report any temperature excursions outside of specified ranges.
   • Document deviations in the Temperature Excursion Log (Annexure-5).
2. Corrective Actions:
   • Implement corrective actions such as equipment repair or transfer of materials to backup storage.
   • Record corrective actions in the Corrective Action Log (Annexure-6).

5.4 Calibration and Validation of Temperature Devices

1. Device Calibration:
   • Calibrate temperature monitoring devices quarterly to ensure accuracy.
   • Document calibration activities in the Calibration Log (Annexure-7).
2. Validation of Temperature Zones:
   • Perform temperature mapping during validation to ensure uniform conditions within zones.
   • Record validation data in the Temperature Zone Validation Log (Annexure-8).

5.5 Training and Compliance Audits

1. Personnel Training:
   • Provide training to warehouse staff on proper handling and monitoring of temperature-sensitive materials.
   • Document training sessions in the Training Log (Annexure-9).
2. Internal Audits:
   • Conduct bi-annual audits of temperature-controlled zones to ensure compliance with GMP standards.
   • Record audit results in the Internal Audit Log (Annexure-9).

6. Abbreviations

• SOP: Standard Operating Procedure
• GMP: Good Manufacturing Practice
• QA: Quality Assurance
• HVAC: Heating, Ventilation, and Air Conditioning

7. Documents

1. Temperature-Controlled Zone Setup Log (Annexure-1)
2. Equipment Maintenance Log (Annexure-2)
3. Monitoring Device Installation Log (Annexure-3)
4. Temperature and Humidity Monitoring Log (Annexure-4)
5. Temperature Excursion Log (Annexure-5)
6. Corrective Action Log (Annexure-6)
7. Calibration Log (Annexure-7)
8. Temperature Zone Validation Log (Annexure-8)
9. Training Log (Annexure-9)

8. References

• 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals
• WHO Good Storage Practices for Pharmaceuticals
• FDA Guidance on Temperature-Controlled Storage and Transport

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

Annexure-1: Temperature-Controlled Zone Setup Log

Date	Zone Name	Temperature Range	Setup By
24/04/2025	Cold Storage A	2-8°C	Ravi Kumar

Annexure-2: Equipment Maintenance Log

Date	Equipment Name	Maintenance Activity	Performed By
24/04/2025	HVAC System	Filter Replacement	Neha Verma

Annexure-3: Monitoring Device Installation Log

Date	Device Name	Location	Installed By
24/04/2025	Data Logger	Cold Storage A	Amit Joshi

Annexure-4: Temperature and Humidity Monitoring Log

Date	Time	Temperature (°C)	Humidity (%)	Checked By
24/04/2025	09:00 AM	4°C	40%	Kiran Patel

Annexure-5: Temperature Excursion Log

Date	Zone Name	Excursion Details	Reported By
24/04/2025	Cold Storage A	Temperature rose to 10°C for 2 hours	Ravi Kumar

Annexure-6: Corrective Action Log

Date	Issue	Corrective Action Taken	Performed By
24/04/2025	HVAC Failure	Repaired HVAC and relocated materials to backup storage	Maintenance Team

Annexure-7: Calibration Log

Date	Device Name	Calibration Result	Calibrated By
24/04/2025	Data Logger	Passed	QA Team

Annexure-8: Temperature Zone Validation Log

Date	Zone Name	Validation Result	Validated By
24/04/2025	Cold Storage A	Validated – Uniform Temperature Distribution	QA Manager

Annexure-9: Training Log

Date	Employee Name	Training Topic	Trainer	Remarks
24/04/2025	Ravi Kumar	Temperature Monitoring and Handling Excursions	QA Manager	Completed Successfully

Revision History:

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
01/01/2024	1.0	Initial Version	New SOP Implementation	QA Head
24/04/2025	2.0	Added detailed procedures for temperature excursions and calibration.	Regulatory Update	QA Head