initiate documentation, and manage workflow adjustments.

4. Accountability

The Head – Manufacturing is accountable for ensuring timely reporting, resolution, and documentation of breakdowns.

5. Procedure

5.1 Initial Response to Breakdown

1. Operator must stop the equipment immediately using the emergency stop button if required.
2. Isolate the area by placing “UNDER MAINTENANCE” signage.
3. Notify the Maintenance Department and Production Supervisor.

5.2 Breakdown Documentation

1. Fill out the Equipment Breakdown Report (Annexure-1).
2. Include details such as equipment ID, type of failure, observed issue, date/time, and operator name.
3. Forward the report to QA and Maintenance for review and action.

5.3 Maintenance Investigation and Resolution

1. Maintenance shall inspect the equipment and log findings in the Equipment Maintenance Log (Annexure-2).
2. Identify root cause: mechanical fault, electrical issue, operator error, wear and tear, etc.
3. Conduct necessary repairs, replace components if needed, and test functionality.
4. Mark the completion time and certify return-to-service status.

5.4 Post-Maintenance Validation

1. Production to perform equipment trial run using distilled water or placebo if applicable.
2. QA to inspect cleaning status, calibration status, and trial performance before reusing.

5.5 Deviation Management

1. If the breakdown causes process deviation, raise a deviation report (Annexure-3) and submit to QA.
2. Evaluate impact on ongoing batches and assess need for batch rejection, reprocessing, or rework.

5.6 Preventive Actions

1. Maintenance should assess whether the issue could have been prevented.
2. Revise Preventive Maintenance Schedule (Annexure-4) if root cause indicates systemic risk.
3. Train operators if operator error was a contributing factor.

6. Abbreviations

• SOP: Standard Operating Procedure
• QA: Quality Assurance
• PM: Preventive Maintenance

7. Documents

1. Equipment Breakdown Report – Annexure-1
2. Equipment Maintenance Log – Annexure-2
3. Deviation Report Form – Annexure-3
4. Revised PM Schedule – Annexure-4

8. References

• GMP Guidelines – Schedule M
• WHO Technical Report Series 1010, Annex 4
• 21 CFR Part 211.182 – Equipment Cleaning and Maintenance

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation	Maintenance Technician	QA Officer	Head – Manufacturing
Department	Engineering	Quality Assurance	Manufacturing

11. Annexures

Annexure-1: Equipment Breakdown Report

Equipment ID	Breakdown Description	Date/Time	Operator	Initial Action Taken

Annexure-2: Equipment Maintenance Log

Date	Issue Identified	Corrective Action	Parts Replaced	Technician Name

Annexure-3: Deviation Report Form

Deviation ID	Description	Impact	Corrective Action	QA Decision

Annexure-4: Preventive Maintenance Schedule

Equipment ID	Activity	Frequency	Last Done	Next Due

Revision History

Revision Date	Revision No.	Change Description	Reason	Approved By
15/05/2022	1.0	Initial version	New SOP	QA Head
09/06/2025	2.0	Added preventive action and PM integration	Regulatory compliance	QA Head