- Purpose
To establish documented evidence that the Temperature & Humidity Monitoring Solutions (TMS) consistently performs as intended and complies with WHO-GMP requirements through Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
- Scope
This protocol applies to all temperature and humidity data loggers, sensors, software, storage devices, alarms, and reporting systems used in:
- Warehouses
- Cold rooms / refrigerators
- Production areas
- Stability chambers
- Finished goods storage
- Responsibilities
| Role | Responsibility |
| QA | Approval, review, deviation handling |
| Engineering | Installation and calibration |
| Production / Stores | System usage |
| IT / Automation | Software & data integrity |
| Validation | Execution and documentation |
- System Description
- Temperature sensor (± accuracy as per spec)
- Data logger with RTC (date & time stamp)
- Storage (SD card / EEPROM / server)
- Software for data analysis & report generation
- Alarm mechanism (visual / audible / email / SMS)
- Installation Qualification (IQ)
Objective
To verify that the TMS is installed as per approved specifications.
IQ Checks
- Equipment installed as per layout & drawings
- Sensor placement at identified critical points
- Power supply and backup verified
- Firmware/software version recorded
- Calibration certificates available & traceable
- SOPs, manuals, and wiring diagrams available
Acceptance Criteria
✔ All components installed correctly
✔ Calibration certificates valid
✔ No installation deviations
- Operational Qualification (OQ)
Objective
To verify that the system operates within defined limits.
OQ Tests
- Temperature measurement accuracy test (low, mid, high range)
- RTC date/time accuracy verification
- Data logging interval verification
- Alarm activation at upper & lower limits
- Power failure & data retention test
- User access & data protection test
Acceptance Criteria
✔ Readings within tolerance
✔ Alarms triggered correctly
✔ No data loss during power interruption
- Performance Qualification (PQ)
Objective
To confirm consistent performance under actual operating conditions.
PQ Tests
- Continuous monitoring for 7–30 days
- Trend analysis for stability
- Excursion simulation & response verification
- Data retrieval, report generation & review
Acceptance Criteria
✔ Continuous accurate data
✔ Excursions detected & logged
✔ Reports acceptable for audits
- Deviations & CAPA
All deviations shall be documented, investigated, and closed with appropriate Corrective and Preventive Actions (CAPA).
- Validation Conclusion
Upon successful completion of IQ, OQ, and PQ, the TMS is deemed validated and GMP compliant.
More Details Read click >> Smart Temperature & Humidity Monitoring Solutions, Temperature & Humidity Monitoring Solutions (TMS)
