SOP for Temperature and Relative Humidity Record
Learn how to write a SOP for temperature and relative humidity record monitoring in the pharmaceutical warehouse to ensure compliance with Good Storage Practices (GSP) and comply with GMP regulations.
1.0 PURPOSE
To describes a standard procedure for monitoring and recording the temperature and relative humidity in the warehouse to ensure that pharmaceutical products are stored under recommended environmental conditions.
2.0 SCOPE
This SOP is applicable to all temperature and humidity monitoring activities conducted in the pharmaceutical warehouse, including storage areas for raw materials, packaging materials, intermediates, and finished goods.
3.0 RESPONSIBILITY
3.1 Warehouse personnel are responsible for daily monitoring and recording of temperature and humidity.
3.2 Engineering/Utility team is responsible for maintenance and calibration of monitoring devices.
3.3 QA personnel are responsible for reviewing the records and ensuring compliance with the SOP.
4.0 ACCOUNTABILITY
The Warehouse Manager and Head of Quality Assurance (QA) are accountable for the implementation and compliance with this SOP.
5.0 ASSOCIATED DOCUMENTS
5.1 SOP for Calibration of Temperature and Relative Humidity Devices
5.2 Temperature and Humidity Log Sheet
5.3 Calibration Certificates of Data Loggers
5.4 Deviation and CAPA Records
6.0 PRECAUTIONS
6.1 Ensure the monitoring devices are calibrated and functioning correctly.
6.2 Do not expose sensors or data loggers to water, direct sunlight, or physical damage.
6.3 Maintain continuous power supply to electronic monitoring systems.
7.0 PROCEDURE
7.1 Install calibrated temperature and humidity data loggers or thermohygrometers in all designated zones of the warehouse based on warehouse mapping.
7.2 Ensure all monitoring devices are installed at representative points of each area (e.g., near entry/exit, central zones, upper and lower racks) and positioned away from direct sunlight, ventilation ducts, and doors.
7.3 Record the temperature and RH readings twice daily (morning and evening) manually or use automated data loggers to capture data at defined intervals (e.g., every 15–30 minutes).
7.4 Compare the recorded readings with the acceptable storage conditions specified below:
| Storage Area | Temperature Range | Relative Humidity (RH) Range |
| Raw Materials Storage Area | 15–25°C | 45–65% RH |
| Finished Goods Area | 15–25°C | 45–65% RH |
| Cold Room | 2–8°C | NMT 60% RH (Not More Than) |
| Hormones/Vitamins Area | 2–8°C or 8–15°C* | 35–50% RH |
| Packaging Materials Area | 15–30°C | 40–65% RH |
| Quarantine Area | 15–25°C | 45–65% RH |
| Rejected Materials Area | 15–25°C | 45–65% RH |
| Controlled Drug Storage Area | 15–25°C | 35–50% RH |
| Refrigerated Products Area | 2–8°C | NMT 60% RH |
| Freezer Area (if applicable) | -20°C ±5°C | N/A |
*Temperature range for Hormone/Vitamin storage depends on product-specific storage label; refer to the material’s storage requirement in the product dossier or COA.
7.5 If any deviation is observed from the specified ranges, immediately inform the QA department. Initiate a deviation report, investigate the root cause, and take appropriate corrective and preventive actions (CAPA).
7.6 Maintain all temperature and humidity records—both manual and electronic—in a secure and traceable manner. Backup electronic records as per the company’s data retention policy.
7.7 Conduct quarterly verification of all monitoring points and ensure periodic calibration of data loggers/thermohygrometers as per the calibration schedule.
8.0 ABBREVIATIONS/DEFINITIONS
8.1 SOP: Standard Operating Procedure
8.2 QA: Quality Assurance
8.3 RH: Relative Humidity
8.4 GSP: Good Storage Practices
8.5 CAPA: Corrective and Preventive Actions
9.0 ANNEXURES
9.1 Annexure 1: Temperature and Humidity Log Sheet Format
Annexure I: Temperature and Humidity Monitoring Log Template
| Date | Time | Location/Area | Temperature (°C) | Humidity (%RH) | Recorder’s Initials | Remarks (if any) |
9.2 Annexure 2: Calibration Record Template
Annexure II: Calibration Record Template
| Instrument ID | Location | Calibration Date | Due Date | Calibration Status | Calibrated By | Remarks |
9.3 Annexure 3: Deviation Report Template
Annexure III: Deviation Record Form
| Deviation No. | Date | Location | Description of Deviation | Observed Value | Limit | Reported By | Investigation Summary | Corrective Action | Preventive Action | Reviewed By | Closure Date |
10. REVISION HISTORY
| Version | Date | Description of Change | Reviewed By | Approved By |
| 1.0 |