meters, heating systems, and filling machinery located in the gel production area.

3. Responsibilities

• Maintenance Engineer: Responsible for scheduling and executing preventive maintenance.
• Production Supervisor: To coordinate equipment availability and oversee cleaning post-maintenance.
• QA Officer: To verify completion and documentation of maintenance activities.

4. Accountability

The Head of Engineering and Head of Manufacturing are accountable for ensuring timely preventive maintenance of all relevant equipment.

5. Procedure

5.1 Maintenance Planning

1. Maintain an equipment master list with unique identification numbers.
2. Prepare an annual preventive maintenance schedule based on manufacturer recommendations and historical data.
3. Update the Maintenance Calendar (Annexure-1) monthly and share it with QA and Production.

5.2 Equipment Shutdown and Preparation

1. Prior to maintenance, stop ongoing production and clean equipment externally.
2. Isolate equipment from the power supply and lockout-tagout procedures must be followed.
3. Post “Under Maintenance” sign at the equipment location.

5.3 Preventive Maintenance Activities

1. Perform inspections based on the checklist provided in Annexure-2.
2. Check and tighten mechanical components, belts, couplings, and fasteners.
3. Lubricate rotating parts as per lubrication schedule.
4. Verify and calibrate sensors and controllers associated with the equipment.
5. Inspect and clean filters, valves, pressure gauges, and seals.

5.4 Post-Maintenance Activities

1. Reconnect the equipment and perform a test run without product.
2. Record the operational parameters and compare with standard values.
3. If equipment performance is satisfactory, remove the maintenance tag and update the status log.
4. Complete the Equipment Maintenance Record (Annexure-3).

5.5 Documentation

1. All maintenance activities must be documented and signed by the responsible technician and verified by QA.
2. Deviations or abnormalities observed during maintenance must be reported through a deviation form.
3. Retain completed records for a minimum of 5 years or as per regulatory guidelines.

6. Abbreviations

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

7. Documents

1. Annual Maintenance Calendar – Annexure-1
2. Preventive Maintenance Checklist – Annexure-2
3. Equipment Maintenance Record – Annexure-3

8. References

• Equipment manufacturer manuals
• GMP and Schedule-M guidelines
• Internal Engineering SOPs

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation	Jr. Production Chemist	QA Executive	Head – Manufacturing
Department	Gel Manufacturing	Quality Assurance	Manufacturing

11. Annexures

Annexure-1: Annual Maintenance Calendar

Month	Equipment ID	Equipment Name	Scheduled Date	Status	Remarks
				Pending/Completed

Annexure-2: Preventive Maintenance Checklist

Parameter	Status (OK/Not OK)	Remarks	Checked By	Date
Motor and Coupling Inspection
Lubrication of Bearings
Sensor Calibration
Temperature Control Function

Annexure-3: Equipment Maintenance Record

Equipment ID	Date of Maintenance	Work Performed	Performed By	Verified By	Remarks

Revision History

Revision Date	Revision No.	Details	Reason	Approved By
01/06/2022	1.0	Initial version	New SOP	QA Head
02/06/2025	2.0	Updated structure and added detailed annexures	Scheduled Review	QA Head