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
- 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.
- 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).
5.2 Storage of Raw Materials in Cold Storage Units
- 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).
- 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
- 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).
- 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
- 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).
- 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).
5.5 Maintenance and Cleaning of Cold Storage Units
- 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).
- 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
- 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).
- 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
- Cold Storage Setup Log (Annexure-1)
- Cold Storage Inventory Log (Annexure-2)
- Material Handling Log (Annexure-3)
- Temperature Monitoring Log (Annexure-4)
- Calibration Log (Annexure-5)
- Deviation Log (Annexure-6)
- Corrective Action Log (Annexure-7)
- Maintenance Log (Annexure-8)
- Cleaning Log (Annexure-9)
- Warehouse Inspection Log (Annexure-10)
- 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 |
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 |