SOP for Handling and Storage of Temperature-Sensitive Raw Materials – V 2.0

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SOP for Handling and Storage of Temperature-Sensitive Raw Materials – V 2.0

Standard Operating Procedure for Handling and Storage of Temperature-Sensitive Raw Materials

Department Warehouse / Quality Assurance
SOP No. SOP/RM/108/2025
Supersedes SOP/RM/108/2022
Page No. Page 1 of 15
Issue Date 08/02/2025
Effective Date 12/02/2025
Review Date 08/02/2026

1. Purpose

This Standard Operating Procedure (SOP) outlines the procedures for the proper handling and storage of temperature-sensitive raw materials to maintain their integrity, stability, and compliance with Good Manufacturing Practices (GMP).

2. Scope

This SOP applies to all temperature-sensitive raw materials, including Active Pharmaceutical Ingredients (APIs), excipients, solvents, and reagents that require specific temperature conditions for storage and handling within the warehouse.

3. Responsibilities

  • Warehouse Personnel: Handle and store temperature-sensitive raw materials according to specified conditions. Monitor and document temperature data.
  • Quality Assurance (QA): Verify compliance with storage requirements, conduct periodic audits, and approve corrective actions if deviations occur.
  • Warehouse Manager: Oversee storage operations, ensure proper functioning of temperature monitoring equipment, and address non-conformities.

4. Accountability

The Warehouse Manager is accountable for the proper storage and handling of temperature-sensitive materials. The QA Manager is responsible for verifying compliance with regulatory requirements through inspections and audits.

5. Procedure

5.1 Identification of Temperature-Sensitive Materials

  1. Material Identification:
    • Identify temperature-sensitive raw materials from supplier documentation, such as the Certificate of Analysis (COA) and Material Safety Data Sheet (MSDS).
    • Label temperature-sensitive materials with clear instructions, including specific temperature ranges.
    • Document identification details in the Material Identification Log (Annexure-1).
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5.2 Storage Requirements for Temperature-Sensitive Materials

  1. Temperature-Controlled Storage:
    • Store materials in temperature-controlled rooms, refrigerators (2°C to 8°C), or freezers (-20°C or as specified).
    • Ensure temperature monitoring devices are calibrated and functioning properly.
    • Document storage conditions in the Storage Condition Log (Annexure-2).
  2. Segregation and Labeling:
    • Segregate temperature-sensitive materials from non-sensitive ones to prevent cross-contamination.
    • Label storage areas and containers with appropriate temperature requirements.
    • Document labeling activities in the Labeling Log (Annexure-3).

5.3 Temperature Monitoring and Documentation

  1. Continuous Monitoring:
    • Monitor storage temperatures continuously using calibrated data loggers and alarms for deviations.
    • Perform manual temperature checks twice daily and compare with automated monitoring data.
    • Record temperature data in the Temperature Monitoring Log (Annexure-4).
  2. Calibration of Monitoring Devices:
    • Calibrate temperature monitoring devices at specified intervals as per manufacturer recommendations.
    • Document calibration activities in the Calibration Log (Annexure-5).

5.4 Handling of Temperature Deviations

  1. Deviation Detection:
    • If a deviation in temperature is detected, immediately investigate the cause and take corrective actions.
    • Isolate affected materials and assess potential quality impact.
    • Document deviations in the Deviation Log (Annexure-6).
  2. Corrective Actions:
    • Transfer materials to backup storage if necessary while the issue is being resolved.
    • QA will evaluate whether the deviation has compromised the material’s integrity and decide on further actions.
    • Record corrective actions in the Corrective Action Log (Annexure-7).

5.5 Transportation of Temperature-Sensitive Materials

  1. Transport Requirements:
    • Use validated cold chain transport systems for moving temperature-sensitive materials within and outside the facility.
    • Ensure materials are packed in insulated containers with temperature loggers to maintain specified conditions during transit.
    • Document transportation conditions in the Transportation Log (Annexure-8).
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5.6 Periodic Review and Compliance Monitoring

  1. Warehouse Inspections:
    • Conduct periodic inspections to verify proper handling and storage of temperature-sensitive materials.
    • Document inspection findings in the Warehouse Inspection Log (Annexure-9).
  2. QA Compliance Audits:
    • QA will perform audits to ensure compliance with storage protocols for temperature-sensitive materials.
    • Document audit findings in the Compliance Audit Log (Annexure-10).

6. Abbreviations

  • SOP: Standard Operating Procedure
  • GMP: Good Manufacturing Practice
  • QA: Quality Assurance
  • COA: Certificate of Analysis
  • MSDS: Material Safety Data Sheet

7. Documents

  1. Material Identification Log (Annexure-1)
  2. Storage Condition Log (Annexure-2)
  3. Labeling Log (Annexure-3)
  4. Temperature Monitoring Log (Annexure-4)
  5. Calibration Log (Annexure-5)
  6. Deviation Log (Annexure-6)
  7. Corrective Action Log (Annexure-7)
  8. Transportation Log (Annexure-8)
  9. Warehouse Inspection Log (Annexure-9)
  10. Compliance Audit Log (Annexure-10)

8. References

  • 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals
  • ICH Q7 – Good Manufacturing Practice for Active Pharmaceutical Ingredients
  • WHO GMP 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: Material Identification Log

Date Material Name Batch Number Temperature Requirement Identified By
08/02/2025 API-X API-X-2025-001 2°C to 8°C Ravi Kumar
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Annexure-2: Storage Condition Log

Date Storage Area Temperature (°C) Humidity (%) Recorded By
08/02/2025 Refrigerated Room 1 4°C 45% Sunita Sharma

Annexure-3: Labeling Log

Date Material Name Batch Number Label Details Labeled By
08/02/2025 API-X API-X-2025-001 Store at 2°C to 8°C Anjali Mehta

Annexure-4: Temperature Monitoring Log

Date Storage Area Temperature (°C) Recorded By
08/02/2025 Refrigerated Room 1 4°C Ravi Kumar

Annexure-5: Calibration Log

Date Device Calibration Status Calibrated By
07/02/2025 Temperature Sensor 001 Calibrated Sunita Sharma

Annexure-6: Deviation Log

Date Deviation Action Taken Reported By
07/02/2025 Temperature exceeded 8°C Transferred materials to backup storage Ravi Kumar

Annexure-7: Corrective Action Log

Date Issue Corrective Action Performed By
07/02/2025 Temperature deviation detected Repaired refrigeration unit Sunita Sharma

Annexure-8: Transportation Log

Date Material Name Batch Number Transport Condition Transported By
08/02/2025 API-X API-X-2025-001 Maintained at 4°C Anjali Mehta

Annexure-9: Warehouse Inspection Log

Date Area Inspected Inspector Findings Corrective Actions
08/02/2025 Refrigerated Room 1 Anjali Mehta No deviations found N/A

Annexure-10: Compliance Audit Log

Date Audit Type Findings Corrective Actions Audited By
09/02/2025 Temperature-Sensitive Material Compliance Audit Compliant N/A Anjali Mehta

Revision History:

Revision Date Revision No. Revision Details Reason for Revision Approved By
01/01/2024 1.0 Initial Version New SOP QA Head
08/02/2025 2.0 Updated Storage and Handling Procedures Regulatory Compliance QA Head
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