Elixir Department: SOP for Use of Manufacturing Control Systems – V 2.0

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Elixir Department: SOP for Use of Manufacturing Control Systems – V 2.0

Standard Operating Procedure for Use of Manufacturing Control Systems in Elixir Production

Department Elixir Department
SOP No. SOP/ELX/075/2025
Supersedes SOP/ELX/075/2022
Page No. Page 1 of 8
Issue Date 11/04/2025
Effective Date 15/04/2025
Review Date 11/04/2026

1. Purpose

To establish a systematic approach for the use, monitoring, and documentation of electronic and automated Manufacturing Control Systems (MCS) used in the production of elixirs to ensure process reliability, traceability, and compliance with GMP.

2. Scope

This SOP applies to all programmable logic controllers (PLC), Human Machine Interfaces (HMI), SCADA systems, and other digital controls used in the Elixir Department for mixing, heating, cooling, volume adjustment, and agitation.

3. Responsibilities

  • Production Operator:
    • Operate the MCS as per validated procedures and authorized access levels.
    • Document system alerts, setpoint deviations, or alarms promptly.
  • Production Supervisor:
    • Ensure system calibration, backups, and audit trail functionality are in place.
  • QA Officer:
    • Verify logs, user permissions, and review audit trails periodically.
  • Engineering Department:
    • Maintain system integrity, perform troubleshooting, and ensure data security.
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4. Accountability

The Head of Production and the Head of Engineering are jointly accountable for ensuring correct

usage, maintenance, and validation of the manufacturing control systems.

5. Procedure

5.1 System Access and Authorization

  1. Only trained personnel with valid usernames and passwords shall operate the MCS.
  2. User roles (e.g., Operator, Supervisor, Administrator) shall be defined and access restricted accordingly.
  3. Change control must be initiated for any modification in user access or system configuration.

5.2 Operation of MCS

  1. Follow the sequence of operation displayed on HMI or SCADA screens.
  2. Set process parameters as per BMR or approved recipe (e.g., temperature, agitation speed, duration).
  3. Review system feedback and ensure critical values are within the specified range before proceeding.

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5.3 Data Logging and Documentation

  1. System shall record process data automatically and generate digital or printed logs.
  2. Backups of process data must be scheduled daily or at the end of each batch.
  3. Operators must sign printed logs and attach them to the BMR for traceability.

5.4 Alarms and Deviation Handling

  1. In case of deviation or alarm:
    • Stop the process (if critical), inform supervisor and QA immediately.
    • Record event code, time, and deviation details in the MCS Alarm Log (Annexure-1).
    • Raise deviation report if required.

5.5 System Maintenance and Calibration

  1. Engineering must verify:
    • Touch screen calibration, sensor accuracy, and communication between components.
    • System validation annually or after major software/hardware changes.

6. Abbreviations

  • SOP: Standard Operating Procedure
  • MCS: Manufacturing Control System
  • HMI: Human Machine Interface
  • PLC: Programmable Logic Controller
  • SCADA: Supervisory Control and Data Acquisition

7. Documents

  1. MCS Alarm Log (Annexure-1)
  2. System Access Authorization Log (Annexure-2)
  3. Process Parameter Printout (attached to BMR)
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8. References

  • 21 CFR Part 11 – Electronic Records and Signatures
  • WHO Annex 5 – Validation of Computerized Systems
  • GAMP 5 – Good Automated Manufacturing Practice

9. SOP Version

Version: 2.0

10. Approval Section

Prepared By Checked By Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: MCS Alarm Log

Date Batch No. Alarm Code Description Action Taken Operator
11/04/2025 ELX-1015 E01 Temperature Exceeded Agitation stopped, QA informed Rajesh Kumar

Annexure-2: System Access Authorization Log

Employee Name User ID Role Authorized By Date
Sunita Reddy SREDDY Supervisor Production Head 10/04/2025

Revision History:

Revision Date Revision No. Revision Details Reason for Revision Approved By
01/01/2024 1.0 Initial SOP Release New Implementation QA Head
11/04/2025 2.0 Included SCADA and Audit Trail Management Compliance Enhancement QA Head
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