Standard Operating Procedure for Monitoring Warehouse Temperature and Humidity in API Manufacturing
| Department | API Manufacturing |
|---|---|
| SOP No. | SOP/API/018/2025 |
| Supersedes | SOP/API/018/2022 |
| Page No. | Page 1 of 10 |
| Issue Date | 13/04/2025 |
| Effective Date | 15/04/2025 |
| Review Date | 13/04/2026 |
1. Purpose
To define a procedure for the routine monitoring and control of temperature and relative humidity (RH) in warehouse areas used for storing raw materials and intermediates to maintain product integrity and ensure compliance with GMP requirements.
2. Scope
This SOP applies to all storage zones including general raw material storage, quarantine, sampling, temperature-controlled areas, and cold rooms within the API manufacturing warehouse.
3. Responsibilities
- Warehouse Staff: Record temperature and RH readings twice daily, calibrate equipment, and report any deviations.
- QA Officer: Review and verify temperature/RH logs and ensure CAPA for excursions.
- Engineering: Maintain HVAC systems, temperature monitors, and data loggers.
4. Accountability
The Warehouse Manager and QA Manager are accountable for the maintenance and review of environmental monitoring records and ensuring proper storage conditions are sustained.
5. Procedure
5.1 Equipment and Installation
- Install calibrated thermohygrometers or validated digital data loggers in:
- General Storage Area
- Quarantine Room
- Sampling Booths
- Cold Room (if available)
- Ensure instruments are:
- Calibrated every 6 months
- Mounted at an average height (approx. 1.5 m from floor)
- Not exposed to direct sunlight or HVAC vents
5.2 Monitoring Frequency and Limits
- Record readings twice daily (once in morning and once in evening) using the “Warehouse Temperature & Humidity Log” (Annexure-1).
- Acceptable range (unless otherwise defined by the material storage requirement):
- Temperature: 15°C to 25°C
- Relative Humidity (RH): NMT 60%
- Use data logger trends to monitor 24-hour conditions.
5.3 Deviation Management
- Record any temperature or humidity deviation outside the acceptable range in the “Deviation Record Form” (Annexure-2).
- Immediately inform QA and initiate impact assessment on stored materials.
- Perform root cause analysis and implement CAPA.
5.4 Preventive Measures
- Ensure warehouse is equipped with:
- Dehumidifiers (if RH frequently exceeds limits)
- Air curtains at entrances
- Sealed walls, ceilings, and temperature-proof insulation for sensitive zones
- Perform weekly HVAC filter cleaning and maintenance as per engineering SOP.
5.5 Documentation
- All records shall be filled in ink with no overwriting.
- Review logs monthly for trend analysis and archive after QA verification.
- Maintain records for a minimum of 5 years or as per retention policy.
6. Abbreviations
- SOP: Standard Operating Procedure
- RH: Relative Humidity
- QA: Quality Assurance
- HVAC: Heating, Ventilation, and Air Conditioning
- CAPA: Corrective and Preventive Action
7. Documents
- Warehouse Temperature & Humidity Log (Annexure-1)
- Deviation Record Form (Annexure-2)
- Calibration Certificate of Instruments (Annexure-3)
8. References
- ICH Q7 – GMP Guidelines for Active Pharmaceutical Ingredients
- WHO TRS 961 Annex 9 – Good Storage Practices
- 21 CFR Part 211.42 – Environmental Control Requirements
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Warehouse Temperature & Humidity Log
| Date | Time | Area | Temperature (°C) | RH (%) | Checked By |
|---|---|---|---|---|---|
| 13/04/2025 | 09:00 | RM Store | 24.1 | 58 |
Annexure-2: Deviation Record Form
| Date | Area | Deviation Observed | Action Taken | Verified By (QA) |
|---|---|---|---|---|
| 12/04/2025 | Cold Room | Temp at 27°C | HVAC checked, stock quarantined |
Annexure-3: Calibration Certificate Register
| Instrument ID | Location | Calibration Date | Next Due Date | Status |
|---|---|---|---|---|
| TH-001 | Sampling Area | 01/04/2025 | 01/10/2025 | Calibrated |
Revision History:
| Revision Date | Revision No. | Revision Details | Reason for Revision | Approved By |
|---|---|---|---|---|
| 01/01/2022 | 1.0 | Initial Release | GMP Requirement | QA Head |
| 13/04/2025 | 2.0 | Incorporated Data Logger Requirements | Audit Recommendation | QA Head |