SOP Guide for Pharma

SOP for Use of Digital Monitoring Systems for Raw Material Storage Conditions – V 2.0

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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

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  1. 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.
  2. 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).
  3. System Validation:
    • Conduct system validation tests to ensure accuracy and reliability.
    • Record validation results in the System Validation Report (Annexure-2).
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    4. 5.2 Daily Monitoring and Alert Management

    1. 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).
    2. 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

    1. 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).
    2. 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

    1. 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).
    2. 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

    1. 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).
    2. 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).
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    6. Abbreviations

    • SOP: Standard Operating Procedure
    • GMP: Good Manufacturing Practice
    • QA: Quality Assurance
    • IT: Information Technology
    • IoT: Internet of Things

    7. Documents

    1. Digital System Installation Log (Annexure-1)
    2. System Validation Report (Annexure-2)
    3. Digital Monitoring Log (Annexure-3)
    4. Alert Response Log (Annexure-4)
    5. Data Integrity Audit Log (Annexure-5)
    6. Data Backup Log (Annexure-6)
    7. System Maintenance Log (Annexure-7)
    8. Troubleshooting Log (Annexure-8)
    9. Digital Monitoring Training Log (Annexure-9)
    10. 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

    Prepared By Checked By Approved By
    Signature
    Date
    Name
    Designation
    Department

    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
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    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