Standard Operating Procedure for Monitoring Temperature and Humidity in the Warehouse
| Department | Warehouse / Quality Assurance |
|---|---|
| SOP No. | SOP/RM/114/2025 |
| Supersedes | SOP/RM/114/2022 |
| Page No. | Page 1 of 15 |
| Issue Date | 14/02/2025 |
| Effective Date | 18/02/2025 |
| Review Date | 14/02/2026 |
1. Purpose
This Standard Operating Procedure (SOP) outlines the processes for monitoring, recording, and maintaining optimal temperature and humidity conditions in the warehouse to ensure the integrity of raw materials.
2. Scope
This SOP applies to all storage areas within the warehouse, including sections designated for temperature-sensitive, humidity-sensitive, and general raw materials.
3. Responsibilities
- Warehouse Personnel: Monitor and record temperature and humidity levels at designated intervals and report deviations.
- Quality Assurance (QA): Verify recorded data, ensure calibration of monitoring devices, and conduct periodic audits.
- Warehouse Manager: Ensure monitoring equipment is functioning correctly and address any environmental control issues.
4. Accountability
The Warehouse Manager is accountable for maintaining the environmental conditions, while the QA Manager ensures compliance with Good Manufacturing Practices (GMP) through audits and inspections.
5. Procedure
5.1 Equipment Selection and Installation
- Selection of Monitoring Devices:
- Use calibrated digital thermometers and hygrometers for accurate temperature and humidity readings.
- Install automated
data loggers in critical storage areas for continuous monitoring.
Document device installation in the Equipment Installation Log (Annexure-1).
Installation Guidelines:
- Place monitoring devices away from doors, windows, or heat sources to avoid inaccurate readings.
- Ensure devices are securely mounted at appropriate heights (1.5m from the floor) for consistent measurement.
5.2 Temperature and Humidity Monitoring Procedures
- Daily Monitoring:
- Record temperature and humidity readings twice daily, at the start and end of the working shift.
- Use automated alerts to detect deviations from the acceptable range.
- Document readings in the Temperature and Humidity Log (Annexure-2).
- Acceptable Ranges:
- Maintain temperatures between 15°C and 25°C unless otherwise specified by the material requirements.
- Maintain relative humidity between 30% and 60%, with tighter controls for specific materials.
5.3 Calibration of Monitoring Devices
- Calibration Frequency:
- Calibrate monitoring devices every six months or as per the manufacturer’s recommendations.
- Use certified calibration standards for accuracy.
- Document calibration activities in the Calibration Log (Annexure-3).
- Verification of Calibration:
- Conduct periodic checks against a reference thermometer and hygrometer to verify accuracy.
- Document verification results in the Calibration Verification Log (Annexure-4).
5.4 Handling Deviations in Environmental Conditions
- Deviation Detection:
- Identify deviations in temperature or humidity through monitoring systems or manual checks.
- Isolate affected materials and assess potential impacts on material integrity.
- Document deviations in the Deviation Log (Annexure-5).
- Corrective Actions:
- Adjust HVAC settings or deploy additional environmental controls to restore acceptable conditions.
- QA will assess if materials require further testing or quarantine.
- Document corrective actions in the Corrective Action Log (Annexure-6).
5.5 Periodic Review and Compliance Monitoring
- Monthly Review of Data:
- Review recorded temperature and humidity data monthly for trends or recurrent deviations.
- Prepare summary reports and submit them to QA for review.
- Document reviews in the Environmental Data Review Log (Annexure-7).
- QA Compliance Audits:
- QA will conduct quarterly audits of environmental monitoring data to ensure compliance with GMP requirements.
- Document audit findings in the Compliance Audit Log (Annexure-8).
6. Abbreviations
- SOP: Standard Operating Procedure
- GMP: Good Manufacturing Practice
- QA: Quality Assurance
- HVAC: Heating, Ventilation, and Air Conditioning
7. Documents
- Equipment Installation Log (Annexure-1)
- Temperature and Humidity Log (Annexure-2)
- Calibration Log (Annexure-3)
- Calibration Verification Log (Annexure-4)
- Deviation Log (Annexure-5)
- Corrective Action Log (Annexure-6)
- Environmental Data Review Log (Annexure-7)
- Compliance Audit Log (Annexure-8)
8. References
- 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals
- ICH Q7 – Good Manufacturing Practice for Active Pharmaceutical Ingredients
- WHO GMP Guidelines
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Equipment Installation Log
| Date | Device ID | Location | Installed By |
|---|---|---|---|
| 14/02/2025 | THERMO-001 | Warehouse A | Ravi Kumar |
Annexure-2: Temperature and Humidity Log
| Date | Time | Temperature (°C) | Humidity (%) | Recorded By |
|---|---|---|---|---|
| 14/02/2025 | 08:00 AM | 22°C | 45% | Sunita Sharma |
Annexure-3: Calibration Log
| Date | Device ID | Calibration Status | Calibrated By |
|---|---|---|---|
| 13/02/2025 | THERMO-001 | Calibrated | Anjali Mehta |
Annexure-4: Calibration Verification Log
| Date | Device ID | Verification Result | Verified By |
|---|---|---|---|
| 13/02/2025 | THERMO-001 | Pass | Ravi Kumar |
Annexure-5: Deviation Log
| Date | Deviation | Action Taken | Reported By |
|---|---|---|---|
| 13/02/2025 | Humidity exceeded 60% | Adjusted HVAC settings | Sunita Sharma |
Annexure-6: Corrective Action Log
| Date | Issue | Corrective Action | Performed By |
|---|---|---|---|
| 13/02/2025 | Temperature fluctuation detected | Repaired HVAC sensor | Ravi Kumar |
Annexure-7: Environmental Data Review Log
| Date | Reviewed By | Findings | Corrective Actions |
|---|---|---|---|
| 14/02/2025 | Anjali Mehta | No deviations found | N/A |
Annexure-8: Compliance Audit Log
| Date | Audit Type | Findings | Corrective Actions | Audited By |
|---|---|---|---|---|
| 15/02/2025 | Environmental Monitoring Audit | Compliant | N/A | Anjali Mehta |
Revision History:
| Revision Date | Revision No. | Revision Details | Reason for Revision | Approved By |
|---|---|---|---|---|
| 01/01/2024 | 1.0 | Initial Version | New SOP | QA Head |
| 14/02/2025 | 2.0 | Updated Monitoring Procedures and Documentation Formats | Regulatory Compliance | QA Head |