SOP for Monitoring Temperature and Humidity in Quarantine Storage – V 2.0

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SOP for Monitoring Temperature and Humidity in Quarantine Storage – V 2.0

Standard Operating Procedure for Monitoring Temperature and Humidity in Quarantine Storage

Department Warehouse / Quality Assurance / Maintenance
SOP No. SOP/RM/070/2025
Supersedes SOP/RM/070/2022
Page No. Page 1 of 15
Issue Date 01/02/2025
Effective Date 05/02/2025
Review Date 01/02/2026

1. Purpose

This Standard Operating Procedure (SOP) outlines the process for monitoring and recording temperature and humidity levels in the quarantine storage area to maintain the quality and integrity of raw materials and ensure compliance with Good Manufacturing Practices (GMP).

2. Scope

This SOP applies to all temperature and humidity monitoring activities conducted in quarantine storage areas where raw materials, including Active Pharmaceutical Ingredients (APIs), excipients, solvents, and temperature-sensitive materials, are stored before Quality Control (QC) testing and Quality Assurance (QA) approval.

3. Responsibilities

  • Warehouse Personnel: Monitor and record temperature and humidity levels in quarantine storage areas as per schedule.
  • Quality Assurance (QA): Review monitoring records, investigate deviations, and ensure compliance with GMP standards.
  • Maintenance Personnel: Calibrate and maintain monitoring equipment and address any technical issues.

4. Accountability

The Warehouse Manager is responsible for ensuring consistent monitoring of environmental conditions. The QA Manager ensures compliance with regulatory standards, and the Maintenance Manager

is responsible for maintaining monitoring devices.

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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).
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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)
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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
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