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.
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
- Refer to the Master Formula Record (MFR) to confirm cold storage requirement (e.g., 2–8°C).
- 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
- Confirm that the cold storage chamber is clean and within temperature range.
- Ensure that the cold storage area has a working temperature logger or chart recorder.
- Verify that the trolleys or containers used for transfer are sanitized and pre-cooled if necessary.
5.3 Transfer Procedure
- Initiate transfer immediately after batch processing or sampling.
- Minimize exposure time to ambient conditions by using shortest transfer route.
- Escort the containers to cold storage and place them in designated rack/area.
- Record temperature at the time of entry into cold storage using a calibrated thermometer.
5.4 Documentation and Monitoring
- Document transfer details in the Cold Storage Transfer Log (Annexure-1).
- Verify and document actual storage temperature using the monitoring device logs.
- QA to verify transfer log and confirm that product remains within allowed temperature range.
5.5 Deviation Handling
- If temperature exceeds defined limits during transfer, report deviation to QA immediately.
- 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
- Cold Storage Transfer Log (Annexure-1)
- Temperature Monitoring Records
- 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 |