Responsibilities

• Bioanalytical or Clinical Staff: Monitors storage temperatures and records excursions.
• Facility Maintenance Team: Investigates equipment malfunction and restores acceptable storage conditions.
• Principal Investigator/Sponsor Representative: Evaluates impact on sample integrity.
• Quality Assurance: Verifies excursion handling and performs trending analysis.

4. Accountability

The Head of Clinical Research or Bioanalytical Operations is accountable for ensuring timely identification, reporting, and resolution of temperature excursions to protect data integrity and subject safety.

5. Procedure

5.1 Temperature Monitoring Setup

1. All sample freezers, refrigerators, and transport boxes must have:
   • Calibrated digital thermometers
   • Continuous data loggers
   • Visual/audible temperature alarms
2. Record daily temperature logs and maintain deviation thresholds:
   • -70°C freezers: Acceptable range ±10°C
   • -20°C freezers: Acceptable range ±5°C
   • 2–8°C refrigerators: Acceptable range ±2°C

5.2 Identification of Temperature Excursion

1. Excursion is defined as any temperature reading outside of validated storage conditions.
2. When identified:
   • Immediately note deviation in Annexure-1: Temperature Excursion Log
   • Activate internal alarm response procedure

5.3 Notification and Impact Assessment

1. Notify:
   • Bioanalytical/clinical team lead
   • QA representative
   • Sponsor representative (if required)
2. Evaluate:
   • Duration and range of excursion
   • Type and quantity of samples/materials impacted
   • Stability data of affected materials (refer CoA)
3. Document assessment in Annexure-2: Excursion Impact Assessment Form

5.4 Corrective and Preventive Actions (CAPA)

1. Determine root cause (e.g., power failure, equipment malfunction, human error).
2. Initiate CAPA using Annexure-3: Excursion CAPA Form.
3. Preventive actions may include:
   • Staff retraining
   • Alarm calibration
   • Alternative backup freezer allocation

5.5 Documentation and Archival

1. Maintain all logs and assessment forms in the Study Master File (SMF) and QA repository.
2. QA to perform monthly trend review and compile Annexure-4: Excursion Trend Report.

6. Abbreviations

• BA: Bioavailability
• BE: Bioequivalence
• CAPA: Corrective and Preventive Action
• QA: Quality Assurance
• CoA: Certificate of Analysis
• SMF: Study Master File

7. Documents

1. Temperature Excursion Log – Annexure-1
2. Excursion Impact Assessment Form – Annexure-2
3. Excursion CAPA Form – Annexure-3
4. Excursion Trend Report – Annexure-4

8. References

• ICH E6(R2) – Good Clinical Practice
• WHO Technical Report Series on Stability of Biological Samples
• 21 CFR Part 58 – GLP 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: Temperature Excursion Log

Date	Time	Location	Recorded Temp	Limit	Action Taken
16/04/2025	03:15 AM	FZ-70A	-56.4°C	-60 to -80°C	Backup freezer used

Annexure-2: Excursion Impact Assessment Form

Date	Material Affected	Exposure Duration	Assessment	Comments
16/04/2025	Plasma Samples	35 min	No impact (stability data supports)	Reviewed by QA

Annexure-3: Excursion CAPA Form

Deviation	Root Cause	Corrective Action	Preventive Action	Closed By
High Temp in FZ-70A	DG switch delay	Manual switch initiated	Alarm escalation protocol revised	QA Manager

Annexure-4: Excursion Trend Report

Month	Total Excursions	Major	Minor	Trend
March 2025	3	1	2	Acceptable

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
12/01/2022	1.0	Initial Release	Regulatory Compliance	QA Head
17/04/2025	2.0	Added trend analysis and formalized impact assessment workflow	Audit Recommendation	QA Head