equipment including filling lines, lyophilizers, autoclaves, laminar airflow units, solution preparation tanks, and other supporting machinery used within the production area.

3. Responsibilities

• Machine Operator: Identify and report any equipment malfunction immediately.
• Maintenance Technician: Investigate and resolve breakdowns and perform repairs as per protocol.
• Production Supervisor: Coordinate communication between departments, assess product risk, and approve restart.
• QA Officer: Review impact on product quality and provide disposition or hold instructions.

4. Accountability

The Head of Production is accountable for ensuring that equipment breakdowns are documented, addressed, and closed in accordance with this SOP and GMP requirements.

5. Procedure

5.1 Immediate Action Upon Breakdown

1. Stop the affected process immediately to prevent further damage or product compromise.
2. Switch on warning indicators or signage for breakdown notification.
3. Inform the Production Supervisor and Engineering/Maintenance Department.
4. Record the breakdown event in the Equipment Breakdown Logbook (Annexure-1).

5.2 Assessment and Risk Evaluation

1. Maintenance team conducts a preliminary diagnosis of the failure cause.
2. Production and QA jointly evaluate:
   • Any impact on in-process material/product
   • Duration of stoppage
   • Cleanroom hold-time limits or exposure
3. If product is affected, move batch to quarantine and initiate deviation report.

5.3 Repair and Restoration

1. Maintenance performs repair as per standard equipment manual or internal protocol.
2. Use calibrated tools and ensure all repairs are documented in Annexure-2: Maintenance Activity Sheet.
3. Ensure all replacement parts are compliant and traceable.

5.4 Post-Repair Validation and Restart

1. Verify proper functioning through dry run (no product).
2. QA to inspect equipment and approve for restart after evaluating cleaning, validation (if required), and impact analysis.
3. Record restart time in Equipment Breakdown Logbook.

5.5 Cleaning Requirements

1. Clean the equipment per applicable SOP before restarting the process.
2. If equipment was open to environment for extended periods, perform additional microbial and particulate monitoring before use.

5.6 Documentation and Reporting

1. Complete all entries in Equipment Breakdown Logbook (Annexure-1).
2. Prepare Deviation Report if applicable (Annexure-3).
3. All maintenance tasks must be recorded in Annexure-2.

5.7 Escalation and Communication

1. If repair exceeds 2 hours or multiple departments are impacted, escalate to Engineering Head and QA Head.
2. Communicate delays to Production Planning Team.

5.8 Preventive Actions

1. Analyze breakdown trends monthly.
2. Identify and plan preventive maintenance schedules accordingly.
3. Revise SOPs if repeated failure modes are identified.

6. Abbreviations

• SOP: Standard Operating Procedure
• QA: Quality Assurance
• GMP: Good Manufacturing Practice
• CAPA: Corrective and Preventive Action

7. Documents

1. Equipment Breakdown Logbook – Annexure-1
2. Maintenance Activity Sheet – Annexure-2
3. Deviation Report – Annexure-3

8. References

• WHO GMP Guidelines – Equipment Management
• ICH Q9 – Quality Risk Management
• 21 CFR Part 211 – Subpart D: Equipment

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: Equipment Breakdown Logbook

Date	Equipment	Batch No.	Breakdown Time	Restart Time	Initial Reported By	Remarks
20/06/2025	Vial Filler	INJ/045/2025	10:45 AM	01:30 PM	Rajesh Kumar	Seal actuator fault

Annexure-2: Maintenance Activity Sheet

Date	Equipment	Description of Work	Parts Replaced	Performed By	Verified By
20/06/2025	Vial Filler	Actuator alignment	Actuator Cylinder	Sunil Patil	QA Officer

Annexure-3: Deviation Report

Deviation No.	DEV-136-2025-01
Date	20/06/2025
Equipment	Vial Filler
Description	Mid-batch breakdown caused hold-time exceedance
Corrective Action	Replaced faulty part, revalidated
Preventive Action	Inspection checklist revised

Revision History

Revision Date	Revision No.	Details	Reason	Approved By
01/07/2022	1.0	Initial SOP release	New Equipment SOP	QA Head
24/06/2025	2.0	Added escalation steps and Annexure templates	Periodic Review	QA Head