Standard Operating Procedure for Proper Positioning of Thermometers and Hygrometers in Storage Areas
| Department | Warehouse / Quality Assurance / Maintenance |
|---|---|
| SOP No. | SOP/RM/159/2025 |
| Supersedes | SOP/RM/159/2022 |
| Page No. | Page 1 of 12 |
| Issue Date | 28/03/2025 |
| Effective Date | 04/04/2025 |
| Review Date | 28/03/2026 |
1. Purpose
This Standard Operating Procedure (SOP) outlines the correct procedures for the placement, monitoring, and maintenance of thermometers and hygrometers in storage areas to ensure accurate recording of temperature and humidity levels. Maintaining optimal environmental conditions is crucial for the integrity and quality of raw materials.
2. Scope
This SOP applies to all storage areas within the warehouse where raw materials are stored. It includes procedures for the positioning, calibration, and documentation of temperature and humidity monitoring devices.
3. Responsibilities
- Warehouse Personnel: Ensure proper placement of thermometers and hygrometers and report any discrepancies or device malfunctions.
- Warehouse Supervisor: Oversee the correct positioning and functioning of monitoring devices and ensure records are maintained.
- Quality Assurance (QA): Conduct regular audits to verify the accuracy of environmental monitoring and approve calibration schedules.
- Maintenance Team: Responsible for the calibration and maintenance of thermometers and hygrometers.
4. Accountability
The Warehouse Manager is accountable
for ensuring proper environmental monitoring in storage areas. The QA Manager is responsible for verifying compliance through audits and documentation.
5. Procedure
5.1 Selection and Calibration of Monitoring Devices
- Device Selection:
- Select calibrated thermometers and hygrometers that meet regulatory standards for accuracy and reliability.
- Devices should have a calibration certificate and be traceable to national or international standards.
- Document device selection in the Device Selection Log (Annexure-1).
- Calibration Schedule:
- All monitoring devices must be calibrated biannually by the Maintenance Team or an external accredited calibration service.
- Maintain calibration records in the Device Calibration Log (Annexure-2).
5.2 Positioning of Thermometers and Hygrometers
- General Positioning Guidelines:
- Place thermometers and hygrometers at locations that represent the average environmental conditions of the storage area.
- Avoid placing devices near doors, vents, windows, or direct sunlight to prevent false readings.
- Document device positioning in the Device Positioning Log (Annexure-3).
- Specific Positioning for Different Storage Areas:
- For temperature-sensitive materials, place additional devices at the front, middle, and rear of the storage area.
- Ensure devices are positioned at the same height as stored materials to reflect accurate environmental conditions.
- Document specific positioning strategies in the Storage Area Monitoring Plan (Annexure-4).
5.3 Monitoring and Documentation
- Daily Monitoring:
- Warehouse personnel must record temperature and humidity readings twice daily, once in the morning and once in the evening.
- Document readings in the Temperature and Humidity Log (Annexure-5).
- Deviation Management:
- In case of deviations from acceptable ranges, immediately inform the Warehouse Supervisor and QA.
- Record deviations and corrective actions in the Environmental Deviation Log (Annexure-6).
5.4 Maintenance of Monitoring Devices
- Routine Checks:
- Inspect thermometers and hygrometers weekly for signs of damage or malfunction.
- Clean devices regularly to prevent dust accumulation that may affect accuracy.
- Document maintenance activities in the Device Maintenance Log (Annexure-7).
- Replacement of Faulty Devices:
- Replace any faulty devices immediately to ensure continuous environmental monitoring.
- Record replacements in the Device Replacement Log (Annexure-8).
6. Abbreviations
- SOP: Standard Operating Procedure
- GMP: Good Manufacturing Practice
- QA: Quality Assurance
- MSDS: Material Safety Data Sheet
7. Documents
- Device Selection Log (Annexure-1)
- Device Calibration Log (Annexure-2)
- Device Positioning Log (Annexure-3)
- Storage Area Monitoring Plan (Annexure-4)
- Temperature and Humidity Log (Annexure-5)
- Environmental Deviation Log (Annexure-6)
- Device Maintenance Log (Annexure-7)
- Device Replacement Log (Annexure-8)
8. References
- 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals
- WHO Guidelines on Good Manufacturing Practices for Pharmaceutical Products
- ISO/IEC 17025: General Requirements for the Competence of Testing and Calibration Laboratories
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
Annexure-1: Device Selection Log
| Date | Device Type | Model Number | Supplier | Selected By |
|---|---|---|---|---|
| 28/03/2025 | Thermometer | THR-500 | ThermoTech Pvt. Ltd. | Ravi Kumar |
| 28/03/2025 | Hygrometer | HYG-200 | EnviroSensors Ltd. | Neha Verma |
Annexure-2: Device Calibration Log
| Date | Device Type | Model Number | Calibration Status | Calibrated By |
|---|---|---|---|---|
| 28/03/2025 | Thermometer | THR-500 | Calibrated | Amit Joshi |
| 28/03/2025 | Hygrometer | HYG-200 | Calibrated | Priya Singh |
Annexure-3: Device Positioning Log
| Date | Device Type | Location | Positioned By |
|---|---|---|---|
| 28/03/2025 | Thermometer | Middle of Storage Room A | Ravi Kumar |
| 28/03/2025 | Hygrometer | Rear of Storage Room B | Neha Verma |
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 |
| 28/03/2025 | 2.0 | Added Maintenance and Deviation Procedures | Enhance Environmental Monitoring Accuracy | QA Head |