Standard Operating Procedure for Storage of Temperature-Sensitive Materials in API Manufacturing
| Department | API Manufacturing |
|---|---|
| SOP No. | SOP/API/006/2025 |
| Supersedes | SOP/API/006/2022 |
| Page No. | Page 1 of 11 |
| Issue Date | 13/04/2025 |
| Effective Date | 15/04/2025 |
| Review Date | 13/04/2026 |
1. Purpose
To describe the procedure for receiving, storing, monitoring, and handling temperature-sensitive raw materials such as APIs, excipients, and solvents that require specific temperature conditions to maintain their quality and stability in the API manufacturing warehouse.
2. Scope
This SOP applies to all temperature-sensitive materials received and stored in cold rooms, refrigerators, or temperature-controlled storage areas within the API manufacturing facility.
3. Responsibilities
- Warehouse Personnel: Store materials in designated temperature zones, record temperature readings, and maintain logs.
- QA Officer: Review temperature monitoring data and investigate deviations.
- Engineering/Maintenance Team: Maintain and calibrate temperature-controlled equipment.
4. Accountability
The Warehouse Manager is accountable for ensuring that temperature-sensitive materials are stored under prescribed conditions and monitored as per regulatory guidelines.
5. Procedure
5.1 Identification of Temperature-Sensitive Materials
- During material receipt, verify storage conditions mentioned in the CoA, MSDS, or label.
- Examples of storage requirements:
- 2°C to 8°C – Refrigerated Storage
- -20°C – Frozen Storage
- 15°C to 25°C – Controlled Room Temperature
- Label containers with “Temperature-Sensitive – Store at [Required Temp]” using color-coded tags.
5.2 Storage Equipment and Infrastructure
- Use validated cold rooms, refrigerators, or deep freezers for storing such materials.
- Each unit should be equipped with:
- Digital temperature display
- 24×7 temperature data logger
- Alarm system for excursions
- Back-up power supply
- Do not overload storage units to ensure uniform temperature circulation.
5.3 Storage Process
- Place materials in their respective designated shelves based on temperature category.
- Maintain physical segregation between different materials.
- Update the “Temperature-Sensitive Storage Log” (Annexure-1) for each batch stored.
5.4 Temperature Monitoring
- Warehouse staff must record temperature twice daily (morning and evening).
- Download and archive data from digital loggers weekly and review for excursions.
- QA should verify and sign off the logs weekly.
- If temperature excursion is noted:
- Label material as “On Hold”
- Inform QA and initiate deviation form
- QA shall assess impact and decide on disposition
5.5 Calibration and Maintenance
- Temperature measuring devices must be calibrated every 6 months or as per SOP.
- Calibration certificates shall be attached to the “Calibration Log” (Annexure-2).
- Preventive maintenance shall be conducted monthly and recorded.
5.6 Handling During Power Failure
- Ensure storage units are connected to UPS or generator.
- In case of extended outage:
- Transfer materials to a validated backup storage
- Document transfer in the “Emergency Transfer Log” (Annexure-3)
6. Abbreviations
- SOP: Standard Operating Procedure
- QA: Quality Assurance
- MSDS: Material Safety Data Sheet
- UPS: Uninterruptible Power Supply
7. Documents
- Temperature-Sensitive Storage Log (Annexure-1)
- Calibration Log (Annexure-2)
- Emergency Transfer Log (Annexure-3)
8. References
- ICH Q7 – Good Manufacturing Practice for Active Pharmaceutical Ingredients
- WHO TRS 961 Annex 9 – Storage and Transport of Time and Temperature-Sensitive Products
- 21 CFR Part 211.142 – Warehousing procedures
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | Rajesh Kumar | Sunita Reddy | Manoj Verma |
| Designation | Warehouse Officer | QA Executive | QA Manager |
| Department | API Manufacturing | Quality Assurance | Quality Assurance |
11. Annexures
Annexure-1: Temperature-Sensitive Storage Log
| Date | Material | Batch No. | Storage Unit | Temp. Recorded | Initials |
|---|---|---|---|---|---|
| 13/04/2025 | Enzyme A | ENZ202504 | Refrigerator 01 | 5.2°C | RK |
Annexure-2: Calibration Log
| Date | Device ID | Calibrated By | Next Due | Certificate No. |
|---|---|---|---|---|
| 01/04/2025 | THERMO-02 | Caltech Pvt. Ltd. | 01/10/2025 | CAL/2025/042 |
Annexure-3: Emergency Transfer Log
| Date | Material | From | To | Reason | Authorized By |
|---|---|---|---|---|---|
| 13/04/2025 | Enzyme A | Refrigerator 01 | Backup Cold Room | Power Failure | Sunita Reddy |
Revision History:
| Revision Date | Revision No. | Revision Details | Reason for Revision | Approved By |
|---|---|---|---|---|
| 01/01/2022 | 1.0 | Initial SOP | New Process | QA Head |
| 13/04/2025 | 2.0 | Added Calibration & Emergency Transfer Log | GMP Upgrade | QA Head |