Standard Operating Procedure for Managing and Documenting Temperature Excursions in Storage
| Department | Warehouse / Quality Assurance / Maintenance |
|---|---|
| SOP No. | SOP/RM/154/2025 |
| Supersedes | SOP/RM/154/2022 |
| Page No. | Page 1 of 12 |
| Issue Date | 23/03/2025 |
| Effective Date | 30/03/2025 |
| Review Date | 23/03/2026 |
1. Purpose
This Standard Operating Procedure (SOP) outlines the process for identifying, managing, and documenting temperature excursions in storage areas to ensure the integrity of raw materials. Temperature excursions can compromise product quality, so it is essential to monitor, respond, and document these events in compliance with GMP standards.
2. Scope
This SOP applies to all storage areas within the warehouse, including controlled room temperature zones, cold storage units, and temperature-sensitive material areas. It covers the identification of excursions, corrective actions, and documentation procedures.
3. Responsibilities
- Warehouse Personnel: Monitor temperature logs, identify excursions, and report deviations immediately.
- Maintenance Team: Address equipment malfunctions and restore appropriate storage conditions.
- Quality Assurance (QA): Evaluate the impact of excursions on material quality and ensure proper documentation and corrective actions.
- Warehouse Manager: Oversee the implementation of this SOP and ensure timely resolution of excursions.
4. Accountability
The Warehouse Manager is accountable for ensuring continuous monitoring of storage temperatures, while the QA Manager ensures all temperature excursions are properly documented and evaluated for product impact.
5. Procedure
5.1 Temperature Monitoring System
- Continuous Monitoring:
- All storage areas must be equipped with calibrated temperature monitoring devices that log data continuously.
- Ensure alarms are configured to alert staff when temperatures exceed predefined thresholds.
- Document temperature readings in the Temperature Monitoring Log (Annexure-1).
- Manual Temperature Checks:
- Warehouse personnel must perform manual temperature checks twice daily in all storage areas.
- Record manual readings in the Manual Temperature Check Log (Annexure-2).
5.2 Identification of Temperature Excursions
- Defining Excursions:
- A temperature excursion is any deviation from the established storage conditions as per product specifications.
- Examples include storage temperatures rising above 25°C for room-temperature materials or falling below 2°C for refrigerated items.
- Immediate Actions:
- Upon detection of an excursion, notify the Warehouse Supervisor and QA immediately.
- Document the incident in the Temperature Excursion Report (Annexure-3).
5.3 Managing Temperature Excursions
- Initial Response:
- Verify the accuracy of the temperature reading using an independent thermometer.
- Isolate affected materials to prevent further exposure.
- Document immediate actions in the Initial Excursion Response Log (Annexure-4).
- Corrective Actions:
- The Maintenance team must investigate and resolve the root cause of the excursion (e.g., equipment malfunction, power failure).
- Record corrective actions in the Temperature Excursion Corrective Action Log (Annexure-5).
5.4 Evaluation and Documentation
- Impact Assessment:
- QA will evaluate whether the temperature excursion has impacted the quality or stability of the raw materials.
- Materials that are compromised must be quarantined and either re-tested or discarded based on QA’s recommendation.
- Document assessments in the Temperature Excursion Impact Assessment Log (Annexure-6).
- Final Documentation and Review:
- Ensure all excursions, responses, and corrective actions are documented comprehensively.
- Submit final reports for QA approval and file them in the Temperature Excursion Final Review Log (Annexure-7).
6. Abbreviations
- SOP: Standard Operating Procedure
- GMP: Good Manufacturing Practice
- QA: Quality Assurance
- CAPA: Corrective and Preventive Action
7. Documents
- Temperature Monitoring Log (Annexure-1)
- Manual Temperature Check Log (Annexure-2)
- Temperature Excursion Report (Annexure-3)
- Initial Excursion Response Log (Annexure-4)
- Temperature Excursion Corrective Action Log (Annexure-5)
- Temperature Excursion Impact Assessment Log (Annexure-6)
- Temperature Excursion Final Review Log (Annexure-7)
8. References
- 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals
- WHO Guidelines on Good Manufacturing Practices for Pharmaceutical Products
- ICH Q1A (R2) – Stability Testing of New Drug Substances and Products
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
Annexure-1: Temperature Monitoring Log
| Date | Storage Area | Temperature Recorded | Monitoring Device ID | Recorded By |
|---|---|---|---|---|
| 23/03/2025 | Cold Storage Unit A | 4°C | TS-1001 | Ravi Kumar |
| 23/03/2025 | Warehouse Room Temperature Zone | 22°C | TS-1002 | Neha Verma |
Annexure-2: Manual Temperature Check Log
| Date | Time | Storage Area | Temperature Recorded | Checked By |
|---|---|---|---|---|
| 23/03/2025 | 9:00 AM | Freezer Unit B | -18°C | Amit Joshi |
| 23/03/2025 | 2:00 PM | Room Temperature Storage | 24°C | Priya Singh |
Annexure-3: Temperature Excursion Report
| Date | Storage Area | Excursion Details | Duration | Reported By |
|---|---|---|---|---|
| 23/03/2025 | Cold Storage Unit A | Temperature rose to 8°C | 2 hours | Ravi Kumar |
| 23/03/2025 | Room Temperature Zone | Temperature exceeded 25°C | 3 hours | Neha Verma |
Annexure-4: Initial Excursion Response Log
| Date | Storage Area | Immediate Action Taken | Performed By |
|---|---|---|---|
| 23/03/2025 | Cold Storage Unit A | Moved materials to backup cold storage | Amit Joshi |
| 23/03/2025 | Room Temperature Zone | Checked HVAC system functionality | Priya Singh |
Annexure-5: Temperature Excursion Corrective Action Log
| Date | Storage Area | Corrective Action Taken | Performed By |
|---|---|---|---|
| 23/03/2025 | Cold Storage Unit A | Repaired malfunctioning compressor | Ravi Kumar |
| 23/03/2025 | Room Temperature Zone | Reset thermostat settings | Neha Verma |
Annexure-6: Temperature Excursion Impact Assessment Log
| Date | Material Name | Batch Number | Impact Assessment | Assessed By |
|---|---|---|---|---|
| 23/03/2025 | Citric Acid | CA-1234 | No impact, material stable | Amit Joshi |
| 23/03/2025 | Sodium Hydroxide | NAOH-5678 | Re-testing required | Priya Singh |
Annexure-7: Temperature Excursion Final Review Log
| Date | Excursion Summary | Final Review Status | Approved By |
|---|---|---|---|
| 23/03/2025 | Cold Storage Unit A excursion, no product impact | Closed | QA Head |
| 23/03/2025 | Room Temperature Zone excursion, re-testing required | Ongoing | QA Head |
Revision History:
| Revision Date | Revision No. | Revision Details | Reason for Revision | Approved By |
|---|---|---|---|---|
| 01/01/2024 | 1.0 | Initial Version | New SOP Implementation | QA Head |
| 23/03/2025 | 2.0 | Added corrective action protocols for excursions | To align with updated GMP and ICH guidelines | QA Head |