Standard Operating Procedure for Monitoring Ambient Conditions of Sample Freezers in BA/BE Studies
| Department | BA-BE Studies |
|---|---|
| SOP No. | SOP/BA-BE/076/2025 |
| Supersedes | SOP/BA-BE/076/2022 |
| Page No. | Page 1 of 9 |
| Issue Date | 17/04/2025 |
| Effective Date | 20/04/2025 |
| Review Date | 17/04/2026 |
1. Purpose
To establish a consistent and reliable procedure for monitoring the ambient temperature and relative humidity conditions of rooms where -20°C and -70°C sample freezers are installed, thereby ensuring optimal operating conditions and sample integrity in BA/BE studies.
2. Scope
This SOP applies to all areas within the clinical site or laboratory where biological sample freezers used in BA/BE studies are located and ambient condition monitoring is required.
3. Responsibilities
- Facility Maintenance Staff: Responsible for maintaining HVAC systems and reporting any anomalies.
- Lab Technician: Records daily temperature and humidity values.
- QA Officer: Reviews logs periodically and ensures compliance during audits.
4. Accountability
The Facility Manager is accountable for ensuring ambient conditions are monitored and maintained within the specified limits and that proper documentation is retained.
5. Procedure
5.1 Installation and Calibration of Thermo-Hygrometers
- Install validated and calibrated digital thermo-hygrometers in each freezer room.
- Place sensors at a height of approximately 1.5 meters from the floor, away from direct vents and heat sources.
- Calibrate instruments every 6 months or as per manufacturer’s recommendation.
5.2 Monitoring Frequency
- Record ambient temperature and humidity:
- Twice daily (e.g., 9:00 AM and 5:00 PM)
- In Annexure-1: Ambient Condition Monitoring Log
- Acceptable ambient conditions:
- Temperature: 18°C to 25°C
- Relative Humidity (RH): 40% to 60%
5.3 Alarm and Alert System
- Set upper and lower alert limits in devices to notify staff in case of deviation.
- Ensure audio or SMS alerts are enabled for remote monitoring.
5.4 Deviation Handling
- In case of deviation:
- Record in Annexure-2: Ambient Condition Deviation Log
- Investigate cause and take immediate corrective action (e.g., adjust HVAC, limit access)
- Inform QA and document CAPA
5.5 Preventive Maintenance
- Perform monthly checks of air circulation, vents, and calibration due dates of instruments.
- Document maintenance activities in Annexure-3: Preventive Maintenance Log.
6. Abbreviations
- BA: Bioavailability
- BE: Bioequivalence
- HVAC: Heating, Ventilation and Air Conditioning
- RH: Relative Humidity
- QA: Quality Assurance
7. Documents
- Ambient Condition Monitoring Log – Annexure-1
- Ambient Condition Deviation Log – Annexure-2
- Preventive Maintenance Log – Annexure-3
8. References
- ICH Q10 – Pharmaceutical Quality System
- US FDA Guidance on Storage Conditions
- WHO TRS 961 Annex 9 – Good Storage Practice
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Ambient Condition Monitoring Log
| Date | Time | Temperature (°C) | Humidity (%) | Checked By | Remarks |
|---|---|---|---|---|---|
| 17/04/2025 | 09:00 | 22.1 | 45 | Ravi Nair | Normal |
Annexure-2: Ambient Condition Deviation Log
| Date | Time | Observed Value | Limit Breached | Corrective Action | Reviewed By |
|---|---|---|---|---|---|
| 16/04/2025 | 17:00 | 27.5°C | Temp > 25°C | HVAC serviced, air duct opened | Dr. Arvind Shah |
Annexure-3: Preventive Maintenance Log
| Date | Activity | Performed By | Remarks |
|---|---|---|---|
| 10/04/2025 | HVAC filter cleaning | Maintenance Team | Completed |
Revision History:
| Revision Date | Revision No. | Details | Reason | Approved By |
|---|---|---|---|---|
| 10/01/2022 | 1.0 | Initial version | Operational SOP | QA Head |
| 17/04/2025 | 2.0 | Added alarm triggers and preventive maintenance log | Audit enhancement | QA Head |