SOP for Use of Digital Monitoring Systems for Raw Material Storage Conditions – V 2.0
Standard Operating Procedure for Use of Digital Monitoring Systems for Raw Material Storage Conditions
| Department |
Warehouse / Quality Assurance / IT |
| SOP No. |
SOP/RM/171/2025 |
| Supersedes |
SOP/RM/171/2022 |
| Page No. |
Page 1 of 16 |
| Issue Date |
06/04/2025 |
| Effective Date |
13/04/2025 |
| Review Date |
06/04/2026 |
1. Purpose
This Standard Operating Procedure (SOP) outlines the process for implementing, using, and maintaining digital monitoring systems to track raw material storage conditions, ensuring compliance with Good Manufacturing Practices (GMP).
2. Scope
This SOP applies to all digital systems used for monitoring temperature, humidity, pressure, and other environmental factors affecting raw material storage in the warehouse, including data loggers, cloud-based monitoring systems, and IoT devices.
3. Responsibilities
- Warehouse Personnel: Monitor system alerts and respond to deviations promptly.
- IT Department: Ensure system functionality, software updates, and cybersecurity protocols.
- Quality Assurance (QA): Audit digital records, validate system accuracy, and ensure data integrity.
4. Accountability
The Warehouse Manager is accountable for daily monitoring, while the IT Manager is responsible for maintaining system integrity and security. The QA Manager ensures all records meet regulatory requirements.
5. Procedure
5.1 System Installation and Validation
- System Selection:
- Select a GMP-compliant digital monitoring system with real-time tracking capabilities for temperature, humidity, and pressure.
- Ensure the system has data backup and alert mechanisms for deviations.
- Installation:
- Install sensors in strategic locations throughout storage areas to cover all critical points.
- Document installation details in the Digital System Installation Log (Annexure-1).
- System Validation:
- Conduct system validation tests to ensure accuracy and reliability.
- Record validation results in the System Validation Report (Annexure-2).
5.2 Daily Monitoring and Alert Management
- Monitoring Process:
- Check the digital dashboard daily for temperature, humidity, and pressure readings.
- Set automated alerts for deviations beyond specified thresholds.
- Record daily readings in the Digital Monitoring Log (Annexure-3).
- Alert Management:
- Respond to system alerts immediately to prevent material compromise.
- Document alert details and corrective actions in the Alert Response Log (Annexure-4).
5.3 Data Integrity and Backup
- Data Integrity:
- Ensure all data entries are timestamped, accurate, and unalterable.
- Enable user authentication to control access to the digital monitoring system.
- Record data integrity audits in the Data Integrity Audit Log (Annexure-5).
- Backup Procedures:
- Perform automatic data backups daily to a secure, cloud-based server.
- Conduct monthly manual backups to an external storage device.
- Document backup activities in the Data Backup Log (Annexure-6).
5.4 System Maintenance and Troubleshooting
- Routine Maintenance:
- Perform monthly software updates and calibration of sensors.
- Clean sensors and ensure they are free from obstruction or damage.
- Document maintenance in the System Maintenance Log (Annexure-7).
- Troubleshooting:
- Identify system errors using diagnostic tools provided by the manufacturer.
- Report unresolved issues to the IT department for escalation.
- Record troubleshooting efforts in the Troubleshooting Log (Annexure-8).
5.5 Training and Compliance
- Training Program:
- Conduct bi-annual training sessions for warehouse personnel and QA staff on system use and data interpretation.
- Maintain training records in the Digital Monitoring Training Log (Annexure-9).
- Regulatory Compliance:
- Ensure digital monitoring practices align with FDA, WHO, and GMP guidelines.
- Conduct quarterly audits and document results in the Regulatory Compliance Audit Log (Annexure-10).
6. Abbreviations
- SOP: Standard Operating Procedure
- GMP: Good Manufacturing Practice
- QA: Quality Assurance
- IT: Information Technology
- IoT: Internet of Things
7. Documents
- Digital System Installation Log (Annexure-1)
- System Validation Report (Annexure-2)
- Digital Monitoring Log (Annexure-3)
- Alert Response Log (Annexure-4)
- Data Integrity Audit Log (Annexure-5)
- Data Backup Log (Annexure-6)
- System Maintenance Log (Annexure-7)
- Troubleshooting Log (Annexure-8)
- Digital Monitoring Training Log (Annexure-9)
- Regulatory Compliance Audit Log (Annexure-10)
8. References
- 21 CFR Part 11 – Electronic Records; Electronic Signatures
- 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals
- WHO Guidelines on Good Manufacturing Practices for Pharmaceutical Products
- FDA Data Integrity and Compliance with CGMP Guidance
9. SOP Version
Version: 2.0
10. Approval Section
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Prepared By |
Checked By |
Approved By |
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| Name |
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Annexure-1: Digital System Installation Log
| Date |
System Component |
Location |
Installed By |
| 06/04/2025 |
Temperature Sensor |
Zone A – Shelf 1 |
Ravi Kumar |
| 06/04/2025 |
Humidity Sensor |
Zone B – Shelf 3 |
Neha Verma |
Annexure-2: System Validation Report
| Date |
Validation Parameter |
Result |
Validated By |
| 07/04/2025 |
Temperature Accuracy |
Within Limits |
Amit Joshi |
| 07/04/2025 |
Humidity Accuracy |
Pass |
Priya Singh |
Annexure-3: Digital Monitoring Log
| Date |
Time |
Temperature (°C) |
Humidity (%) |
Pressure (psi) |
Monitored By |
| 07/04/2025 |
09:00 AM |
22°C |
45% |
101 psi |
Ravi Kumar |
| 07/04/2025 |
12:00 PM |
23°C |
46% |
100 psi |
Neha Verma |
Annexure-4: Alert Response Log
| Date |
Time |
Alert Description |
Action Taken |
Handled By |
| 07/04/2025 |
10:30 AM |
High Temperature Alert – 26°C |
Adjusted HVAC Settings |
Priya Singh |
| 07/04/2025 |
03:00 PM |
Low Humidity Alert – 35% |
Checked Dehumidifier |
Amit Joshi |
Annexure-5: Data Integrity Audit Log
| Date |
Audit Description |
Findings |
Corrective Action |
Audited By |
| 07/04/2025 |
Review of Data Logs for Tampering |
No Issues Found |
Not Applicable |
Ravi Kumar |
| 07/04/2025 |
System Time Synchronization Check |
Minor Time Drift |
Corrected Time Settings |
Neha Verma |
Annexure-6: Data Backup Log
| Date |
Backup Type |
Storage Location |
Status |
Performed By |
| 07/04/2025 |
Automatic Backup |
Cloud Server |
Successful |
Amit Joshi |
| 07/04/2025 |
Manual Backup |
External Hard Drive |
Successful |
Priya Singh |
Annexure-7: System Maintenance Log
| Date |
Component |
Maintenance Activity |
Status |
Performed By |
| 07/04/2025 |
Temperature Sensor |
Calibration |
Completed |
Ravi Kumar |
| 07/04/2025 |
Monitoring Software |
Software Update |
Completed |
Neha Verma |
Annexure-8: Troubleshooting Log
| Date |
Issue Description |
Root Cause |
Corrective Action |
Resolved By |
| 07/04/2025 |
No Data from Humidity Sensor |
Loose Connection |
Reconnected Sensor |
Amit Joshi |
| 07/04/2025 |
Software Crash on Dashboard |
Outdated Version |
Updated Software |
Priya Singh |
Annexure-9: Digital Monitoring Training Log
| Date |
Employee Name |
Training Topic |
Trainer |
| 07/04/2025 |
Amit Joshi |
Using Digital Monitoring Systems |
QA Manager |
| 07/04/2025 |
Priya Singh |
Data Integrity and Backup Procedures |
IT Manager |
Annexure-10: Regulatory Compliance Audit Log
| Date |
Audit Area |
Compliance Status |
Corrective Actions |
Audited By |
| 07/04/2025 |
Data Integrity Standards |
Compliant |
Not Applicable |
Ravi Kumar |
| 07/04/2025 |
System Validation Procedures |
Non-Compliant (Minor) |
Updated Validation Protocol |
Neha Verma |
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 |
| 06/04/2025 |
2.0 |
Updated with new monitoring protocols and digital backup procedures. |
Regulatory Compliance Update |
QA Head |