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
- 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).
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
- Temperature Monitoring Devices:
- Install temperature and humidity monitoring devices with alarms for deviations.
- Document device installation in the Monitoring Device Installation Log (Annexure-3).
- 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
- Deviation Identification:
- Immediately report any temperature excursions outside of specified ranges.
- Document deviations in the Temperature Excursion Log (Annexure-5).
- 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
- Device Calibration:
- Calibrate temperature monitoring devices quarterly to ensure accuracy.
- Document calibration activities in the Calibration Log (Annexure-7).
- 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
- 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).
- 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
- Temperature-Controlled Zone Setup Log (Annexure-1)
- Equipment Maintenance Log (Annexure-2)
- Monitoring Device Installation Log (Annexure-3)
- Temperature and Humidity Monitoring Log (Annexure-4)
- Temperature Excursion Log (Annexure-5)
- Corrective Action Log (Annexure-6)
- Calibration Log (Annexure-7)
- Temperature Zone Validation Log (Annexure-8)
- 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 |