SOP Guide for Pharma

Elixir Department: SOP for Cold Storage Transfer of Heat-Sensitive Batches – V 2.0

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Elixir Department: SOP for Cold Storage Transfer of Heat-Sensitive Batches – V 2.0

Standard Operating Procedure for Cold Storage Transfer of Heat-Sensitive Batches in Elixir Manufacturing

Department Elixir Department
SOP No. SOP/ELX/111/2025
Supersedes SOP/ELX/111/2022
Page No. Page 1 of 8
Issue Date 11/04/2025
Effective Date 15/04/2025
Review Date 11/04/2026

1. Purpose

To define the procedure for safe and controlled transfer of heat-sensitive elixir batches to cold storage facilities, maintaining product integrity and ensuring compliance with temperature requirements.

2. Scope

This SOP applies to all heat-sensitive bulk or intermediate elixir batches requiring cold storage transfer within the Elixir Department after manufacturing or before packaging.

3. Responsibilities

  • Production Operator:
    • Ensure proper sealing and labeling of containers before transfer.
    • Escort batch containers to the designated cold storage area.
  • Production Supervisor:
    • Verify temperature conditions and documentation before and after transfer.
  • QA Officer:
    • Ensure temperature compliance, review records, and approve batch storage.
See also  Elixir Department: SOP for Use of Validated Cleaning Detergents - V 2.0

4. Accountability

The Head of Production is accountable for ensuring that all heat-sensitive batches are stored and transferred under controlled cold conditions with proper documentation.

5. Procedure

5.1 Identification of Heat-Sensitive

Batches
  1. Refer to the Master Formula Record (MFR) to confirm cold storage requirement (e.g., 2–8°C).
  2. Ensure batch containers are tightly closed and labeled with:
    • Batch Number
    • Product Name
    • Storage Condition (e.g., “Store at 2–8°C”)
    • Transfer Date and Time

5.2 Pre-Transfer Checks

  1. Confirm that the cold storage chamber is clean and within temperature range.
  2. Ensure that the cold storage area has a working temperature logger or chart recorder.
  3. Verify that the trolleys or containers used for transfer are sanitized and pre-cooled if necessary.

5.3 Transfer Procedure

  1. Initiate transfer immediately after batch processing or sampling.
  2. Minimize exposure time to ambient conditions by using shortest transfer route.
  3. Escort the containers to cold storage and place them in designated rack/area.
  4. Record temperature at the time of entry into cold storage using a calibrated thermometer.

5.4 Documentation and Monitoring

  1. Document transfer details in the Cold Storage Transfer Log (Annexure-1).
  2. Verify and document actual storage temperature using the monitoring device logs.
  3. QA to verify transfer log and confirm that product remains within allowed temperature range.

5.5 Deviation Handling

  1. If temperature exceeds defined limits during transfer, report deviation to QA immediately.
  2. Hold the batch under quarantine until impact assessment is completed.

6. Abbreviations

  • SOP: Standard Operating Procedure
  • QA: Quality Assurance
  • BMR: Batch Manufacturing Record
  • MFR: Master Formula Record

7. Documents

  1. Cold Storage Transfer Log (Annexure-1)
  2. Temperature Monitoring Records
  3. Batch Manufacturing Record (BMR)

8. References

  • WHO TRS 961 – Stability Testing and Cold Chain Management
  • 21 CFR Part 211.142 – Storage of Drug Products
  • Internal SOP on Deviation Management

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 Transfer Log

Date Batch No. Product Name Time of Transfer Storage Temp (°C) Transferred By QA Verified
11/04/2025 ELX-1047 Elixir A 14:30 4.5 Rajesh Kumar Sunita Reddy

Revision History:

Revision Date Revision No. Revision Details Reason for Revision Approved By
01/01/2024 1.0 Initial SOP Release New SOP QA Head
11/04/2025 2.0 Added deviation handling and labeling steps Cold Chain Compliance QA Head
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