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