Never Adjust Cleanroom Thermostats Without QA Notification

Do Not Adjust Cleanroom Thermostats Without QA Authorization

Remember: Any change to cleanroom temperature settings must be done only after QA approval—unauthorized changes can lead to GMP violations.

Why This Matters in GMP

Cleanroom environments rely on strict control of temperature, humidity, pressure, and airflow to maintain classification and protect product quality. Thermostats are calibrated to sustain validated conditions that align with the facility’s HVAC qualification. Unauthorized adjustments to these settings—however minor they may seem—can disrupt airflow patterns, affect pressure differentials, and lead to condensation or microbial proliferation. These environmental fluctuations can compromise both product safety and environmental monitoring results. GMP requires changes to be risk-assessed and controlled, especially when they impact critical processing zones or the stability of pharmaceutical materials.

Also Read: Clean Sampling Tools After Each Use to Prevent Cross-Contamination

Regulatory and Compliance Implications

According to FDA 21 CFR Part 211.42, pharmaceutical facilities must have appropriate environmental control systems, and changes to these systems must be documented and validated. 21 CFR Part 211.68 further mandates control of automated systems, including environmental monitoring devices like thermostats. EU GMP Annex 1 places strong emphasis on maintaining defined cleanroom conditions, and any deviation from validated environmental ranges must be justified and recorded.

WHO GMP requires proper documentation and qualification of HVAC systems, specifying that personnel should not tamper with environmental control equipment without prior authorization. Schedule M in India mandates controlled environmental parameters with restricted access to their control systems. Regulatory inspectors often look for audit trails of changes, QA oversight, deviation logs, and HVAC validation documents. Unauthorized thermostat adjustments—if linked to non-conforming results or batch failures—can trigger serious data integrity concerns and GMP citations.

Also Read: Avoid Water Stagnation in GMP Drains and Sinks to Prevent Contamination

Implementation Best Practices

Restrict access to thermostats and HVAC control panels to trained engineering or QA personnel only.
Establish an SOP requiring prior QA approval for any environmental setting change.
Log all approved adjustments, reasons for change, impact assessments, and post-change verifications.
Integrate Building Management Systems (BMS) with access control and audit trails.
Educate staff about the risks of unauthorized temperature adjustments in GMP zones.

Regulatory References

FDA 21 CFR Part 211.42 – Design and Construction Features
FDA 21 CFR Part 211.68 – Automated Systems
EU GMP Annex 1 – Environmental Monitoring and Cleanroom Control
WHO GMP – HVAC System Management
Schedule M – Environmental Control Requirements

Also Read: How to Leverage ANVISA GMP for Regulatory Approvals in Brazil