Standard Operating Procedure for Remote Monitoring of Batch Parameters in Elixir Manufacturing

Department	Elixir Department
SOP No.	SOP/ELX/158/2025
Supersedes	SOP/ELX/158/2022
Page No.	Page 1 of 10
Issue Date	11/04/2025
Effective Date	15/04/2025
Review Date	11/04/2026

1. Purpose

To define a standard procedure for the remote monitoring of critical batch parameters (e.g., temperature, agitation speed, pH, batch timing) in elixir manufacturing, ensuring real-time control, compliance, and data integrity.

2. Scope

This SOP applies to all SCADA, MES, or IoT-based platforms used in the Elixir Department for remote access and monitoring of process parameters related to mixing tanks, holding vessels, transfer lines, and environmental conditions.

3. Responsibilities

• Production Operator:
  • Initiate and verify batch parameters in the system.
  • Alert designated personnel in case of remote alarms or out-of-spec parameters.
• Engineering Department:
  • Ensure uninterrupted network connectivity, sensor integration, and dashboard calibration.
• QA Officer:
  • Review parameter logs and remote alerts for data integrity and compliance.

4. Accountability

The Automation Head is accountable for configuration and system validation. The Production Head ensures operational compliance. QA is responsible for oversight and regulatory readiness.

5. Procedure

5.1 System Configuration

1. Ensure all sensors (temperature, RPM, pH, volume) are connected and calibrated.
2. Verify the gateway/server is online and communicating with cloud-based dashboards or MES.
3. Log in using authorized credentials with 2-factor authentication (if applicable).
4. Select the active batch number and verify live status indicators for:
   • Agitation speed (RPM)
   • Tank temperature (°C)
   • Batch progress and time remaining
   • pH readings (where applicable)

5.2 Remote Access and Monitoring

1. Authorized personnel (Shift Supervisor, QA, Automation Team) may access dashboards via secure tablet, desktop, or mobile view.
2. Set SMS/email alerts for threshold deviations (e.g., Temp > 60°C, pH < 3.5, RPM fluctuation).
3. Periodically validate displayed values against control room records every shift.
4. Document login access, alerts, and interventions in the Remote Monitoring Logbook (Annexure-1).

5.3 Alarm Handling

1. When an alert is received:
   • Notify the control room or on-site operator.
   • Verify the parameter using local display or SCADA panel.
   • Take corrective action as per BMR and record deviation if required.
2. Engineering shall investigate any sensor failure or communication error.

5.4 Data Integrity and Audit Trail

1. All parameter changes, alerts, and acknowledgments shall be time-stamped and traceable.
2. Access logs must include user ID, access time, duration, and IP location (if external).
3. Audit trail reports shall be reviewed monthly by QA.

6. Abbreviations

• SOP: Standard Operating Procedure
• SCADA: Supervisory Control and Data Acquisition
• MES: Manufacturing Execution System
• IoT: Internet of Things
• QA: Quality Assurance

7. Documents

1. Remote Monitoring Logbook (Annexure-1)
2. Sensor Calibration Certificate
3. Audit Trail Review Log

8. References

• 21 CFR Part 11 – Electronic Records and Signatures
• ICH Q9 – Quality Risk Management
• WHO TRS 1019 – Use of Automation in GMP Environments

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Remote Monitoring Logbook

Date	Batch No.	Parameter Monitored	Alert Triggered	Action Taken	Logged By	Remarks
11/04/2025	ELX-2025-034	Temperature	Yes (62.5°C)	Agitator paused; cooling initiated	Sunita Reddy	Resolved remotely

Revision History:

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
01/01/2024	1.0	Initial Release	New SOP	QA Head
11/04/2025	2.0	Inclusion of IoT Dashboard and 2FA Login	System Upgrade	QA Head