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

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

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5.1 System Installation and Validation

  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).

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).
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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).

6. Abbreviations

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

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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

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
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