SOP Guide for Pharma

Elixir Department: SOP for Control Panel Usage and Programming – V 2.0

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Elixir Department: SOP for Control Panel Usage and Programming – V 2.0

Standard Operating Procedure for Control Panel Usage and Programming in Elixir Manufacturing

Department Elixir Department
SOP No. SOP/ELX/139/2025
Supersedes SOP/ELX/139/2022
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 the procedure for safe operation and programming of control panels used in elixir manufacturing equipment to ensure proper execution of batch processes, data accuracy, and equipment protection.

2. Scope

This SOP is applicable to all programmable logic control (PLC)-based and digital control panels used for mixing tanks, heating systems, recirculation loops, filling machines, and related processing equipment in the Elixir Department.

3. Responsibilities

  • Production Operator:
    • Operate and monitor control panel during batch processing.
    • Enter process parameters as per BMR/MFR instructions.
  • Production Supervisor:
    • Verify entered parameters and oversee operations.
  • Engineering Department:
    • Program or modify control logic, maintain and calibrate sensors and interfaces.
  • QA Officer:
    • Review programming logs and control panel records during batch review.
See also  Elixir Department: SOP for Deviation Management - V 2.0

4. Accountability

The Production Head is accountable for ensuring correct panel operation and data integrity. The Engineering Head is responsible for hardware and software integrity and security.

5. Procedure

5.1 Pre-Operation Checks

  1. Ensure the control panel is clean, free from dust and moisture, and labeled “CALIBRATED.”
  2. Check that all emergency stop buttons are functional.
  3. Ensure the panel is powered and all connected instruments are properly detected.
  4. Verify that access to the panel is limited to trained personnel only.

5.2 Parameter Entry and Programming

  1. Login using authorized credentials (if applicable).
  2. Select the batch number or production recipe as per BMR/MFR.
  3. Enter required parameters:
    • Mixing time and RPM
    • Temperature setpoint
    • Recirculation duration
    • Filling volume (if applicable)
  4. Double-check all values and save the program before initiating operation.
  5. Record all entered values in the Control Panel Logbook (Annexure-1).
See also  Elixir Department: SOP for Dispensing Solvents and Vehicles - V 2.0

5.3 Monitoring During Operation

  1. Observe the live display of all operational parameters.
  2. Ensure all alarms, interlocks, and timers are functioning correctly.
  3. Record readings periodically (every 15–30 minutes) or as specified in BMR.
  4. Do not make parameter changes mid-batch unless approved by QA and logged properly.

5.4 Post-Operation Shutdown

  1. Switch off heating, mixing, or filling functions from the control panel.
  2. Log out from the interface if user-specific login is enabled.
  3. Record batch completion time and shutdown confirmation in the logbook.

5.5 Panel Maintenance and Safety

  1. Do not open panel enclosures unless authorized by Engineering.
  2. Never override or bypass control panel safety features or alarms.
  3. Ensure the panel is grounded and surge-protected.
  4. Label faulty or inactive panels as “UNDER MAINTENANCE.”

6. Abbreviations

  • SOP: Standard Operating Procedure
  • QA: Quality Assurance
  • PLC: Programmable Logic Controller
  • BMR: Batch Manufacturing Record
  • MFR: Master Formula Record
See also  Elixir Department: SOP for Volume Reconciliation During Manufacturing - V 2.0

7. Documents

  1. Control Panel Operation Log (Annexure-1)
  2. BMR for respective batch
  3. Maintenance and Calibration Certificates

8. References

  • 21 CFR Part 11 – Electronic Records and Signatures
  • WHO GMP Guidelines – Equipment Operation
  • ICH Q9 – Quality Risk Management

9. SOP Version

Version: 2.0

10. Approval Section

Prepared By Checked By Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Control Panel Operation Log

Date Batch No. Panel ID Parameters Set Start Time End Time Operator Remarks
11/04/2025 ELX-1066 CP-MIX-04 Mix: 45 min @ 100 RPM; Temp: 60°C 09:00 10:10 Rajesh Kumar Auto Cycle Successful

Revision History:

Revision Date Revision No. Revision Details Reason for Revision Approved By
01/01/2024 1.0 Initial SOP Release New SOP QA Head
11/04/2025 2.0 Updated for PLC control and secure access protocols System Upgrade QA Head
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