as mixing vessels, heating tanks, and storage units.

3. Responsibilities

• Engineering Team: Responsible for preventive maintenance and calibration.
• Production Staff: Responsible for daily usage monitoring and reporting anomalies.
• QA Personnel: Responsible for review and verification of maintenance records.

4. Accountability

The Head of Engineering and Head of Manufacturing shall be accountable for compliance with this SOP.

5. Procedure

5.1 Daily Monitoring

1. Operators must inspect and record the temperature controller display before starting the batch.
2. Verify that the set-point and current readings match the batch requirements.
3. Note any alarms or unusual behavior and escalate to Engineering if needed.

5.2 Weekly Inspection

1. Engineering personnel shall perform visual checks of connectors, sensors, and wires.
2. Ensure the digital display and alarm functionality are working properly.
3. Clean the controller’s exterior with a dry lint-free cloth.

5.3 Preventive Maintenance (Monthly)

1. Disconnect the power supply before maintenance work.
2. Open the control panel, inspect internal components for dust, corrosion, or loose terminals.
3. Check all input/output terminals and wiring integrity.
4. Tighten any loose screws or connections.
5. Update maintenance record in the Temperature Controller Maintenance Log (Annexure-1).

5.4 Calibration (Quarterly)

1. Perform calibration using a certified temperature simulator or master thermometer.
2. Compare set values with actual output and adjust if deviation exceeds ±1°C.
3. Document calibration values in Calibration Report (Annexure-2).

5.5 Breakdown Handling

1. Immediately tag and isolate faulty controllers.
2. Raise maintenance request through SAP or internal portal.
3. Use replacement unit if production is ongoing and require real-time control.
4. Document the breakdown and corrective action in Breakdown Log (Annexure-3).

5.6 Labeling and Status Tag

1. Ensure each temperature controller has a status tag indicating ‘Calibrated’, ‘Under Maintenance’ or ‘Do Not Use’ as applicable.
2. Status tags to be maintained and replaced after each maintenance or calibration.

6. Abbreviations

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

7. Documents

1. Temperature Controller Maintenance Log – Annexure-1
2. Calibration Report – Annexure-2
3. Breakdown Log – Annexure-3
4. Preventive Maintenance Checklist – Annexure-4

8. References

• Equipment Manufacturer’s Maintenance Manual
• WHO GMP Guidelines
• Schedule M – Temperature Control Systems

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: Temperature Controller Maintenance Log

Date	Equipment ID	Checked By	Remarks	Signature

Annexure-2: Calibration Report

Date	Controller ID	Set Temp (°C)	Actual Temp (°C)	Deviation	Adjusted	Calibrated By
					Yes / No

Annexure-3: Breakdown Log

Date	Controller ID	Issue Observed	Corrective Action	Action By	Signature

Annexure-4: Preventive Maintenance Checklist

Activity	Status (OK/Not OK)	Remarks	Date	Checked By
Visual Inspection
Wiring & Connections
Sensor Function
Display Accuracy

Revision History

Revision Date	Revision No.	Details	Reason	Approved By
05/06/2022	1.0	Initial version	New SOP	QA Head
02/06/2025	2.0	Format updated, annexures added	Scheduled Review	QA Head