(GMP).

2. Scope

This SOP is applicable to all automated components of the filling lines including programmable logic controllers (PLCs), human-machine interfaces (HMIs), servo systems, SCADA interfaces, and associated software control systems in the sterile injectable production area.

3. Responsibilities

• Automation Engineer: Conduct scheduled checks and validations, maintain system backup and logs.
• Production Supervisor: Verify automation performance during operations and report abnormalities.
• QA Officer: Review compliance records, deviations, and validate system changes.

4. Accountability

The Head of Engineering is accountable for ensuring this SOP is followed, and QA Head is accountable for GMP oversight and final approval of any changes to automation systems.

5. Procedure

5.1 System Overview and Components

• PLC: Controls logic and operations of filling, stoppering, and movement mechanisms.
• HMI: Operator interface for parameter display and command input.
• Servo Drives: Control motion precision for filling accuracy.
• SCADA: Supervisory system for centralized monitoring, alarms, and reporting.

5.2 Daily Checks before Batch Start

1. Power ON sequence should follow system design (PLC → HMI → SCADA).
2. Verify touchscreen calibration and responsiveness of HMI.
3. Check for absence of unresolved alarms or error codes.
4. Ensure communication status between PLC and peripherals is green (Annexure-1).
5. Verify interlocks such as vial presence detection, fill-no-vial logic, safety door lock, etc.

5.3 System Validation and Backup

1. All new installations must undergo IQ, OQ, and PQ before operational use.
2. Version control must be maintained for all PLC logic, HMI scripts, and SCADA programs.
3. System backups must be stored offline and updated monthly.

5.4 Periodic Preventive Maintenance Checks

1. Verify software patch updates if applicable (Annexure-2).
2. Test emergency shutdown systems and alarm activation monthly.
3. Perform system cleaning using ESD-safe tools; avoid chemical contact with HMIs.

5.5 Alarm & Event Management

1. Ensure that all critical alarms (e.g., fill error, servo fault, vial jam) are active and loggable.
2. Alarms must be time-stamped and reviewed by Production and QA at batch end.
3. Deviations must be logged when alarms impact process integrity (Annexure-3).

5.6 User Access Control and Audit Trails

1. User roles must be defined (Operator, Supervisor, Admin).
2. Passwords must expire every 90 days and be changed immediately upon personnel departure.
3. Audit trails must be enabled and non-editable. QA must review trails for every batch (Annexure-4).

5.7 Documentation and Reporting

1. Maintain Automation System Check Log for each day the system is used (Annexure-5).
2. Backup schedules and logs must be reviewed monthly by the Engineering Head.
3. Deviations, changes, or errors must be recorded in Change Control System.

6. Abbreviations

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

7. Documents

• Annexure-1: Daily Automation System Pre-Check Sheet
• Annexure-2: Preventive Maintenance Log
• Annexure-3: Alarm Deviation Report
• Annexure-4: Audit Trail Review Template
• Annexure-5: Automation System Check Log

8. References

• 21 CFR Part 11 – Electronic Records and Signatures
• GAMP 5 – Good Automated Manufacturing Practice
• ICH Q9 – Quality Risk Management

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation	Automation Engineer	QA Executive	Head QA
Department	Engineering	Quality Assurance	Quality Assurance

11. Annexures

Annexure-1: Daily Automation System Pre-Check Sheet

Date	System	Check Item	Status	Operator
24/06/2025	Filling PLC	Comms OK	✓	Ravi Kumar

Annexure-2: Preventive Maintenance Log

Date	Component	Activity	Performed By
20/06/2025	SCADA Server	Software Backup	Ajay Verma

Annexure-3: Alarm Deviation Report

Alarm	Date	Cause	Impact	CAPA
Fill Volume Fault	22/06/2025	Nozzle Block	Batch Hold	Routine Filter Check

Annexure-4: Audit Trail Review Template

Date	User Action	System Module	Reviewed By	Comments
24/06/2025	Speed Change	Servo Control	QA Officer	Acceptable

Annexure-5: Automation System Check Log

Date	System	Status	Remarks	Engineer
24/06/2025	PLC + HMI	OK	All Good	Sachin Yadav

Revision History

Revision Date	Version	Description	Reason	Approved By
01/01/2022	1.0	Initial Issue	New SOP	QA Head
24/06/2025	2.0	Added Annexures and Updated Version Control	Annual Review	QA Head