is responsible for maintaining monitoring devices.

5. Procedure

5.1 Equipment Setup and Calibration

1. Equipment Installation:
   • Install calibrated digital thermometers, hygrometers, and data loggers in the quarantine storage areas.
   • Position equipment at representative locations, avoiding direct exposure to sunlight, ventilation ducts, or doors.
2. Calibration:
   • Calibrate temperature and humidity monitoring equipment quarterly or as per manufacturer’s guidelines.
   • Document calibration activities in the Calibration Log (Annexure-1).

5.2 Temperature and Humidity Monitoring

1. Monitoring Schedule:
   • Monitor and record temperature and humidity readings twice daily, once at the start of the shift and once at the end.
   • Document readings in the Temperature and Humidity Monitoring Log (Annexure-2).
2. Acceptable Ranges:
   • Temperature and humidity ranges must comply with the specified storage conditions for each material:
     • Standard materials: 15°C to 25°C, 30% to 50% RH
     • Temperature-sensitive materials: 2°C to 8°C or as specified

5.3 Handling Deviations

1. Deviation Identification:
   • Immediately report any readings outside the acceptable range to the QA Manager and document in the Deviation Report (Annexure-3).
   • Tag affected materials as ‘Hold’ until further investigation is completed.
2. Corrective Actions:
   • QA will investigate the root cause and determine if materials have been compromised.
   • Corrective actions may include adjusting HVAC systems, relocating materials, or recalibrating equipment.
   • Document corrective actions in the Corrective Action Log (Annexure-4).

5.4 Data Review and Reporting

1. Weekly Review:
   • QA personnel must review temperature and humidity logs weekly to ensure compliance with storage conditions.
   • Sign and date reviewed logs and file them for audit purposes.
2. Monthly Reporting:
   • Prepare a monthly summary of temperature and humidity data, highlighting any deviations or trends.
   • Submit the report to the QA Manager for review and archiving.

6. Abbreviations

• SOP: Standard Operating Procedure
• GMP: Good Manufacturing Practice
• QA: Quality Assurance
• QC: Quality Control
• RH: Relative Humidity
• HVAC: Heating, Ventilation, and Air Conditioning

7. Documents

1. Calibration Log (Annexure-1)
2. Temperature and Humidity Monitoring Log (Annexure-2)
3. Deviation Report (Annexure-3)
4. Corrective Action Log (Annexure-4)

8. References

• 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals
• ICH Q7 – Good Manufacturing Practice for Active Pharmaceutical Ingredients
• EU Guidelines on Good Distribution Practices (GDP)

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Calibration Log

Date	Equipment ID	Calibrated By	Next Calibration Date	Remarks
01/02/2025	THERMO-001	Ravi Kumar	01/05/2025	Calibrated Successfully
01/02/2025	HYGRO-002	Sunita Sharma	01/05/2025	No Issues Detected

Annexure-2: Temperature and Humidity Monitoring Log

Date	Time	Temperature (°C)	Humidity (%RH)	Checked By	Remarks
01/02/2025	09:00 AM	22°C	45%	Ravi Kumar	Within Limits
01/02/2025	05:00 PM	24°C	48%	Sunita Sharma	Within Limits

Annexure-3: Deviation Report

Date	Deviation Description	Reported By	Corrective Action Taken	Verified By (QA)
02/02/2025	Temperature Exceeded 25°C	Ravi Kumar	Adjusted HVAC Settings	Anjali Mehta

Annexure-4: Corrective Action Log

Date	Issue	Corrective Action	Responsible Person	Follow-Up Required
02/02/2025	Humidity Drop Below 30%	Checked and Calibrated Hygrometer	Ajay Singh	Yes

Revision History:

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
01/01/2024	1.0	Initial Version	New SOP	QA Head
01/02/2025	2.0	Updated Monitoring and Deviation Handling Procedures	Regulatory Compliance	QA Head