Standard Operating Procedure for Calibration of Temperature and Humidity Monitoring Devices in Storage
| Department | Warehouse / Quality Assurance / Maintenance |
|---|---|
| SOP No. | SOP/RM/183/2025 |
| Supersedes | SOP/RM/183/2022 |
| Page No. | Page 1 of 15 |
| Issue Date | 18/04/2025 |
| Effective Date | 25/04/2025 |
| Review Date | 18/04/2026 |
1. Purpose
This Standard Operating Procedure (SOP) outlines the process for calibrating temperature and humidity monitoring devices in raw material storage areas to ensure accurate environmental monitoring and compliance with Good Manufacturing Practices (GMP).
2. Scope
This SOP applies to all temperature and humidity monitoring devices, including data loggers, thermometers, hygrometers, and automated environmental monitoring systems used in the storage of raw materials.
3. Responsibilities
- Warehouse Personnel: Ensure all monitoring devices are calibrated as per schedule and report any discrepancies.
- Quality Assurance (QA) Team: Verify calibration records and ensure compliance with regulatory requirements.
- Maintenance Team: Perform calibration procedures and maintain calibration equipment in proper working condition.
4. Accountability
The Maintenance Manager is accountable for the proper calibration of devices, the QA Manager ensures compliance with GMP standards, and the Warehouse Manager oversees the overall environmental monitoring process.
5. Procedure
5.1 Calibration
Schedule and Documentation
- Establishing Calibration Schedule:
- Prepare a calibration schedule for all temperature and humidity monitoring devices, ensuring compliance with manufacturer recommendations and regulatory requirements.
- Document the schedule in the Calibration Schedule Log (Annexure-1).
- Calibration Records:
- Maintain accurate records of all calibration activities, including device details, calibration results, and personnel involved.
- Record calibration details in the Calibration Record Log (Annexure-2).
5.2 Calibration Procedure
- Preparation:
- Ensure calibration equipment is in good working condition and traceable to national or international standards.
- Document the equipment status in the Calibration Equipment Log (Annexure-3).
- Performing Calibration:
- Compare device readings against the standard reference equipment at predefined temperature and humidity points.
- Record results in the Calibration Result Log (Annexure-4).
5.3 Handling Non-Conforming Devices
- Identification and Isolation:
- If a device fails calibration, label it as ‘Out of Calibration’ and remove it from service immediately.
- Document non-conformance in the Non-Conformance Log (Annexure-5).
- Corrective Actions:
- Investigate the root cause of non-conformance and perform necessary repairs or replacements.
- Record corrective actions in the Corrective Action Log (Annexure-6).
5.4 Verification and Quality Assurance
- QA Review:
- The QA team must review calibration records and ensure devices meet required standards before returning them to service.
- Document QA reviews in the QA Review Log (Annexure-7).
5.5 Training and Continuous Improvement
- Personnel Training:
- Conduct regular training sessions for relevant staff on calibration procedures and the importance of data accuracy.
- Record training activities in the Calibration Training Log (Annexure-8).
- Audit and Review:
- Perform periodic audits to assess the effectiveness of calibration procedures and identify areas for improvement.
- Document audits in the Calibration Audit Log (Annexure-9).
6. Abbreviations
- SOP: Standard Operating Procedure
- GMP: Good Manufacturing Practice
- QA: Quality Assurance
- RH: Relative Humidity
7. Documents
- Calibration Schedule Log (Annexure-1)
- Calibration Record Log (Annexure-2)
- Calibration Equipment Log (Annexure-3)
- Calibration Result Log (Annexure-4)
- Non-Conformance Log (Annexure-5)
- Corrective Action Log (Annexure-6)
- QA Review Log (Annexure-7)
- Calibration Training Log (Annexure-8)
- Calibration Audit Log (Annexure-9)
8. References
- 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals
- ISO 17025 – General Requirements for the Competence of Testing and Calibration Laboratories
- FDA Guidance on Environmental Control in Pharmaceutical Manufacturing
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
Annexure-1: Calibration Schedule Log
| Date | Device ID | Device Type | Next Calibration Due | Scheduled By |
|---|---|---|---|---|
| 18/04/2025 | TH-001 | Thermometer | 18/10/2025 | Ravi Kumar |
Annexure-2: Calibration Record Log
| Date | Device ID | Calibration Result | Calibrated By |
|---|---|---|---|
| 18/04/2025 | TH-001 | Pass | Neha Verma |
Annexure-3: Calibration Equipment Log
| Date | Equipment ID | Equipment Status | Checked By |
|---|---|---|---|
| 18/04/2025 | EQ-101 | Operational | Amit Joshi |
Annexure-4: Calibration Result Log
| Date | Device ID | Measured Value | Reference Value | Deviation | Calibrated By |
|---|---|---|---|---|---|
| 18/04/2025 | TH-001 | 25.1°C | 25.0°C | +0.1°C | QA Team |
Annexure-5: Non-Conformance Log
| Date | Device ID | Issue Description | Reported By |
|---|---|---|---|
| 18/04/2025 | HY-002 | Reading out of range | Kiran Patel |
Annexure-6: Corrective Action Log
| Date | Device ID | Corrective Action | Performed By |
|---|---|---|---|
| 18/04/2025 | HY-002 | Recalibrated and tested | Ajay Sharma |
Annexure-7: QA Review Log
| Date | Device ID | Review Status | Reviewed By |
|---|---|---|---|
| 18/04/2025 | TH-001 | Approved | QA Supervisor |
Annexure-8: Calibration Training Log
| Date | Employee Name | Training Topic | Trainer | Remarks |
|---|---|---|---|---|
| 18/04/2025 | Ravi Kumar | Calibration Procedures | QA Manager | Completed Successfully |
Annexure-9: Calibration Audit Log
| Date | Audit Area | Findings | Audited By |
|---|---|---|---|
| 18/04/2025 | Warehouse Monitoring Devices | No Issues Found | 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 |
| 18/04/2025 | 2.0 | Updated calibration procedures and added audit requirements. | Regulatory Update | QA Head |