QA personnel involved in the operation, inspection, and support of filling machines in the aseptic manufacturing areas.

3. Responsibilities

• Machine Operator: Identifies and reports issues, performs basic troubleshooting.
• Engineering Technician: Investigates and resolves mechanical/electrical issues.
• Production Supervisor: Approves restart after resolution and ensures documentation.
• QA Officer: Reviews troubleshooting logs and verifies compliance.

4. Accountability

The Head of Production is accountable for implementation of troubleshooting protocols and minimizing machine downtime through adherence to this SOP.

5. Procedure

5.1 Identification of Issue

1. Monitor visual and audible alarms from the filling machine HMI (Human Machine Interface).
2. Pause the operation using emergency stop or pause switch.
3. Record the fault code/error message in Annexure-1: Issue Log Sheet.

5.2 Common Troubleshooting Scenarios

1. Filling Volume Inaccuracy
   • Check calibration of dosing system.
   • Inspect pistons or peristaltic tubing for leaks or wear.
   • Verify container alignment under nozzles.
2. Vial Misalignment or Jamming
   • Check conveyor speed and positioning guides.
   • Remove jammed vials using sterile forceps (if within aseptic area).
3. Nozzle Dripping or Blockage
   • Clean nozzle tip using sterile wipes.
   • Check actuator mechanism and air pressure.
4. Machine Stoppage or Alarm without Obvious Cause
   • Review HMI alarm history log.
   • Reset the system only after QA verification.

5.3 Root Cause Identification

1. Use fishbone diagram or 5-Why analysis for recurring faults.
2. Document root cause analysis in Annexure-2.

5.4 Corrective Actions

1. Replace worn-out parts with validated spares.
2. Recalibrate dosing systems after fixing volume errors.
3. Apply lubrication to mechanical joints (if permitted in cleanroom).

5.5 Preventive Actions

1. Update preventive maintenance schedule if required.
2. Train staff on identified causes and correct handling practices.

5.6 Restart and Documentation

1. Perform visual verification of the fix and sanitize area if required.
2. Enter corrective action taken in Annexure-3: Corrective Action Log.
3. QA to review logs before machine restart.

6. Abbreviations

• SOP: Standard Operating Procedure
• HMI: Human Machine Interface
• QA: Quality Assurance

7. Documents

1. Issue Log Sheet – Annexure-1
2. Root Cause Analysis Sheet – Annexure-2
3. Corrective Action Log – Annexure-3

8. References

• GMP Guidelines for Equipment Handling
• WHO TRS 961 – Annex 6
• ICH Q10 – Pharmaceutical Quality System

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation	Manufacturing Executive	QA Executive	Head QA
Department	Production	Quality Assurance	Quality Assurance

11. Annexures

Annexure-1: Issue Log Sheet

Date	Machine ID	Issue	Error Code	Reported By
18/06/2025	FILL-03	Dripping nozzle	E07	Rajesh Kumar

Annexure-2: Root Cause Analysis Sheet

Date	Issue	Investigation Method	Root Cause	Reviewed By
18/06/2025	Volume deviation	5 Why	Peristaltic tubing fatigue	Sunita Reddy

Annexure-3: Corrective Action Log

Date	Corrective Action	Implemented By	Verified By	Status
18/06/2025	Tubing replaced and recalibrated	Ajay Verma	QA Officer	Closed

Revision History

Revision Date	Revision No.	Details	Reason	Approved By
01/04/2022	1.0	Initial Issue	New SOP	QA Head
18/06/2025	2.0	Updated for structured root cause and action plan	Periodic Review	QA Head