injectable filling machines used in sterile manufacturing lines across the facility. It covers planning, execution, inspection, documentation, and verification of preventive maintenance activities.

3. Responsibilities

• Maintenance Technician: Carry out maintenance as per the defined schedule and checklist.
• Engineering Supervisor: Review and approve completed maintenance records. Ensure availability of spares.
• Production Supervisor: Coordinate equipment shutdown and startup activities.
• QA Personnel: Verify cleanliness and qualification status before releasing machine for production use.

4. Accountability

The Head of Engineering is accountable for ensuring that all injectable filling machines undergo timely preventive maintenance as per the maintenance calendar and are compliant with equipment qualification and GMP requirements.

5. Procedure

5.1 Preventive Maintenance Planning

1. Prepare an annual preventive maintenance calendar for each filling machine based on manufacturer recommendations, past breakdown trends, and regulatory guidelines.
2. Display the approved calendar in the maintenance department and send a copy to Production and QA.

5.2 Preparation before Maintenance

1. Ensure current batch is completed or transferred before initiating maintenance.
2. Verify the machine is decontaminated and cleaned.
3. Switch off the power supply and lock-out/tag-out the energy sources (LOTO).

5.3 Execution of Maintenance

1. Perform maintenance using the approved Preventive Maintenance Checklist (Annexure-1).
2. Activities may include:
   • Lubrication of moving parts
   • Inspection and cleaning of nozzles
   • Replacement of worn-out gaskets, O-rings
   • Calibration of sensors and weighing systems
   • Checking alignment and speed settings
3. Use only approved tools and calibrated instruments.

5.4 Post-Maintenance Verification

1. Conduct trial run using sterile water or dummy vials.
2. Check fill accuracy, line speed, and absence of abnormal vibrations.
3. QA to review trial run results and sign off machine release in the Maintenance Logbook (Annexure-2).

5.5 Documentation

1. Complete and sign the Preventive Maintenance Checklist.
2. Record maintenance activity in the Equipment History Sheet.
3. Scan and archive documents in the Maintenance Document Control System.

5.6 Deviation Handling

1. If any component replacement or extended downtime occurs, document the deviation and perform impact assessment.
2. QA must approve equipment requalification if critical components were replaced.

5.7 Training and Review

1. Maintenance personnel shall undergo training on machine models and revised procedures annually.
2. Engineering department will review PM compliance quarterly and report trends to QA and management.

6. Abbreviations

• SOP: Standard Operating Procedure
• PM: Preventive Maintenance
• LOTO: Lock Out Tag Out
• QA: Quality Assurance
• cGMP: current Good Manufacturing Practices

7. Documents

1. Preventive Maintenance Checklist – Annexure-1
2. Maintenance Logbook – Annexure-2
3. Equipment History Sheet – Annexure-3

8. References

• GMP Guidelines – WHO TRS 986 Annex 2
• 21 CFR Part 211 – Maintenance of Equipment
• ISO 9001:2015 – Clause 8.5.1 and 8.5.3

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: Preventive Maintenance Checklist

Item	Check	Status	Remarks
Lubrication of gears	Yes	Done	OK
Nozzle inspection	Yes	Done	Replaced one

Annexure-2: Maintenance Logbook

Date	Machine ID	Work Performed	Performed By	Reviewed By
20/06/2025	FLM-04	Quarterly PM	Ravi Menon	Sunita Reddy

Annexure-3: Equipment History Sheet

Date	Event	Details	Remarks
01/04/2025	Annual PM	All critical parts checked	Compliant

Revision History

Revision Date	Revision No.	Details	Reason	Approved By
01/05/2022	1.0	Initial SOP release	New system	QA Head
24/06/2025	2.0	Updated checklist and annexures	Periodic review	QA Head