Standard Operating Procedure for Temperature and Humidity Monitoring in Production Areas
1) Purpose
This SOP outlines the procedures for monitoring and controlling temperature and humidity levels in GMP production areas to ensure product quality and compliance with regulatory standards.
2) Scope
This SOP applies to all personnel involved in the monitoring and recording of temperature and humidity levels in controlled areas at [Company Name].
3) Responsibilities
- Operators: Record temperature and humidity levels at specified intervals and report any deviations.
- Maintenance Team: Ensure HVAC systems are functioning properly and within the specified parameters.
- Quality Assurance (QA): Review environmental logs and investigate any deviations from set parameters.
4) Procedure
4.1 Monitoring Equipment
4.1.1 Calibration of Monitoring Devices
- Ensure that all temperature and humidity monitoring devices are calibrated regularly to ensure accuracy. Record all calibrations in the calibration log.
4.1.2 Placement of Monitoring Devices
- Place temperature and humidity sensors in critical areas of the production facility. Ensure sensors are not obstructed and are placed away from heat sources, doors, and windows.
4.2 Recording and Reporting
4.2.1 Temperature and Humidity Readings
- Record temperature and humidity levels at least twice per shift (e.g., every four hours) or as required by production standards. Ensure readings are within the specified range for the product being manufactured.
- If any deviation occurs, report it immediately to the supervisor and document it in the environmental control log.
4.2.2 Response to Deviations
- In the event of temperature or humidity deviations, stop production immediately, and investigate the cause. Make adjustments to HVAC systems if necessary and document corrective actions.
- Record deviations in the deviation log and submit for QA review.
4.3 Post-Monitoring Activities
4.3.1 Documentation
- Record all temperature and humidity readings in the environmental control log. Ensure the log is reviewed by QA at the end of each shift.
4.3.2 Maintenance of HVAC Systems
- Perform routine maintenance of HVAC systems to ensure optimal performance. Document any repairs or maintenance in the equipment log and submit for QA review.
5) Abbreviations, if any
- HVAC: Heating, Ventilation, and Air Conditioning
- QA: Quality Assurance
6) Documents, if any
- Environmental Control Log
- Calibration Log
- Deviation Log
7) References, if any
- Internal SOP for HVAC maintenance
8) SOP Version
Version 1.0
Annexure
1. Temperature and Humidity Monitoring Log Template
| Date | Room ID | Temperature (°C) | Humidity (%) | Operator Initials | QA Approval |
|---|---|---|---|---|---|
| DD/MM/YYYY | Room Identifier | Temperature Measured | Humidity Measured | Operator Name | QA Name |