SOP Guide for Pharma

SOP for Use of Cold Storage Units for Sensitive Raw Materials – V 2.0

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SOP for Use of Cold Storage Units for Sensitive Raw Materials – V 2.0

Standard Operating Procedure for Use of Cold Storage Units for Sensitive Raw Materials

Department Warehouse / Quality Assurance
SOP No. SOP/RM/109/2025
Supersedes SOP/RM/109/2022
Page No. Page 1 of 15
Issue Date 09/02/2025
Effective Date 13/02/2025
Review Date 09/02/2026

1. Purpose

This Standard Operating Procedure (SOP) outlines the proper usage, monitoring, and maintenance of cold storage units for sensitive raw materials to ensure their stability, integrity, and compliance with Good Manufacturing Practices (GMP).

2. Scope

This SOP applies to all temperature-sensitive raw materials, including Active Pharmaceutical Ingredients (APIs), excipients, and reagents that require storage in cold storage units (2°C to 8°C or as specified by manufacturers) within the warehouse.

3. Responsibilities

  • Warehouse Personnel: Operate and monitor cold storage units, ensure proper handling of materials, and maintain accurate records.
  • Quality Assurance (QA): Verify storage conditions, conduct periodic audits, and approve corrective actions in case of deviations.
  • Warehouse Manager: Oversee cold storage operations, ensure calibration of monitoring devices, and train staff on proper usage.

4. Accountability

The Warehouse Manager is accountable for the proper use and maintenance of cold storage units. The QA Manager is responsible for verifying compliance with regulatory

requirements through inspections and audits.

5. Procedure

5.1 Selection and Setup of Cold Storage Units

  1. Selection Criteria:
    • Select cold storage units based on the capacity, temperature range, and sensitivity of the raw materials being stored.
    • Ensure the units have temperature monitoring systems, alarm functions, and backup power supply.
  2. Installation and Setup:
    • Install cold storage units in designated areas with adequate ventilation and access controls.
    • Ensure units are calibrated and validated before initial use.
    • Document installation and validation details in the Cold Storage Setup Log (Annexure-1).
See also  SOP for Controlled Storage of Radioactive or Hazardous Raw Materials - V 2.0

5.2 Storage of Raw Materials in Cold Storage Units

  1. Labeling and Organization:
    • Label each raw material container with temperature storage requirements and batch details.
    • Organize materials in the cold storage unit to allow proper air circulation and prevent cross-contamination.
    • Document storage details in the Cold Storage Inventory Log (Annexure-2).
  2. Handling Procedures:
    • Minimize door openings and exposure time when retrieving materials to maintain stable temperatures.
    • Use insulated containers for temporary transport within the facility.
    • Record material handling activities in the Material Handling Log (Annexure-3).

5.3 Temperature Monitoring and Documentation

  1. Continuous Monitoring:
    • Monitor temperatures continuously using calibrated data loggers connected to an alarm system for deviations.
    • Perform manual temperature checks twice daily and compare with automated readings.
    • Document temperature data in the Temperature Monitoring Log (Annexure-4).
  2. Calibration of Monitoring Devices:
    • Calibrate all temperature monitoring devices at regular intervals as specified by the manufacturer.
    • Document calibration activities in the Calibration Log (Annexure-5).

5.4 Handling of Temperature Deviations

  1. Deviation Detection:
    • If temperature deviations are detected, immediately investigate the cause and take corrective actions.
    • Isolate affected materials and assess potential quality impacts.
    • Document deviations in the Deviation Log (Annexure-6).
  2. Corrective Actions:
    • Transfer materials to an alternative cold storage unit if necessary while resolving the issue.
    • 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).

See also  SOP for Receiving of Raw Materials from Vendors - V 2.0

5.5 Maintenance and Cleaning of Cold Storage Units

  1. Routine Maintenance:
    • Perform routine maintenance checks as per the manufacturer’s recommendations to ensure optimal performance.
    • Document maintenance activities in the Maintenance Log (Annexure-8).
  2. Cleaning Procedures:
    • Clean cold storage units periodically using approved cleaning agents to prevent contamination.
    • Ensure cleaning does not affect temperature-sensitive materials.
    • Document cleaning activities in the Cleaning Log (Annexure-9).

5.6 Periodic Review and Compliance Monitoring

  1. Warehouse Inspections:
    • Conduct periodic inspections to verify proper usage and maintenance of cold storage units.
    • Document inspection findings in the Warehouse Inspection Log (Annexure-10).
  2. QA Compliance Audits:
    • QA will perform audits to ensure compliance with cold storage protocols.
    • Document audit findings in the Compliance Audit Log (Annexure-11).

6. Abbreviations

  • SOP: Standard Operating Procedure
  • GMP: Good Manufacturing Practice
  • QA: Quality Assurance
  • API: Active Pharmaceutical Ingredient

7. Documents

  1. Cold Storage Setup Log (Annexure-1)
  2. Cold Storage Inventory Log (Annexure-2)
  3. Material Handling 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. Maintenance Log (Annexure-8)
  9. Cleaning Log (Annexure-9)
  10. Warehouse Inspection Log (Annexure-10)
  11. Compliance Audit Log (Annexure-11)

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: Cold Storage Setup Log

Date Storage Unit ID Temperature Range Setup By
09/02/2025 CSU-001 2°C to 8°C Ravi Kumar
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Annexure-2: Cold Storage Inventory Log

Date Material Name Batch Number Storage Unit Stored By
09/02/2025 API-X API-X-2025-001 CSU-001 Sunita Sharma

Annexure-3: Material Handling Log

Date Material Name Batch Number Handling Activity Handled By
09/02/2025 API-X API-X-2025-001 Transferred to QC Lab Anjali Mehta

Annexure-4: Temperature Monitoring Log

Date Storage Unit Temperature (°C) Recorded By
09/02/2025 CSU-001 4°C Ravi Kumar

Annexure-5: Calibration Log

Date Device Calibration Status Calibrated By
08/02/2025 Temperature Sensor 001 Calibrated Sunita Sharma

Annexure-6: Deviation Log

Date Deviation Action Taken Reported By
08/02/2025 Temperature exceeded 8°C Transferred materials to backup unit Ravi Kumar

Annexure-7: Corrective Action Log

Date Issue Corrective Action Performed By
08/02/2025 Temperature fluctuation detected Repaired refrigeration unit Sunita Sharma

Annexure-8: Maintenance Log

Date Storage Unit Maintenance Activity Performed By
08/02/2025 CSU-001 Compressor Check Ravi Kumar

Annexure-9: Cleaning Log

Date Storage Unit Cleaning Activity Performed By
08/02/2025 CSU-001 Interior Cleaning with Approved Agent Sunita Sharma

Annexure-10: Warehouse Inspection Log

Date Area Inspected Inspector Findings Corrective Actions
09/02/2025 Cold Storage Area Anjali Mehta No deviations found N/A

Annexure-11: Compliance Audit Log

Date Audit Type Findings Corrective Actions Audited By
10/02/2025 Cold Storage 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
09/02/2025 2.0 Updated Procedures and Documentation Formats Regulatory Compliance QA Head
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