SOP Guide for Pharma

Creams: SOP for Operational Checks of Temperature Control Systems – V 2.0

Auditor

Creams: SOP for Operational Checks of Temperature Control Systems – V 2.0

Standard Operating Procedure for Operational Checks of Temperature Control Systems

Department Creams
SOP No. SOP/CRM/116/2025
Supersedes SOP/CRM/116/2022
Page No. Page 1 of 5
Issue Date 21/01/2026
Effective Date 26/01/2026
Review Date 21/01/2027

1. Purpose

The purpose of this SOP is to establish a procedure for conducting operational checks of temperature control systems in the cream manufacturing process. These checks ensure that the temperature remains within the specified range, preventing product degradation and ensuring quality consistency.

2. Scope

This SOP applies to all temperature control systems used in the Creams Department, including systems used in homogenization, mixing, and storage. It covers daily checks, calibration, and corrective actions to maintain proper temperature control during production.

3. Responsibilities

4. Accountability

The Production Supervisor is accountable for ensuring that all operational checks are carried out as per the SOP and for reporting any temperature deviations. The Maintenance Supervisor is responsible for ensuring the proper functioning and calibration of the temperature control systems.

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5. Procedure

5.1 Daily Operational Checks

  1. Before the start of production, ensure that the temperature control system is turned on and properly configured to the required temperature range specified in the production formula.
  2. Verify that all temperature sensors, gauges, and controllers are functioning correctly. Ensure that the display panels show the correct readings.
  3. Check the calibration of the temperature control system by comparing the readings with a certified thermometer or other approved devices.
  4. Record the initial temperature reading in the Temperature Control Log (Annexure-1). The entry should include the date, time, and equipment ID number.

5.2 Monitoring Temperature During Production

  1. Monitor the temperature of the production equipment (e.g., mixers, homogenizers) continuously throughout the production process.
  2. Ensure that the temperature remains within the specified range, as outlined in the production formula. Any deviation outside the acceptable range should be immediately reported to the Maintenance Team.
  3. If the temperature control system has alarms or indicators for out-of-range conditions, ensure that they are functioning and set to the correct limits.
  4. Perform random checks of the temperature at various points in the production line to ensure uniformity.
  5. Record the temperature readings at regular intervals in the Temperature Control Log (Annexure-1). These readings should be entered at least every 30 minutes during production.

5.3 Troubleshooting Temperature Deviations

  1. If the temperature deviates from the specified range, stop the production process immediately to prevent product quality issues.
  2. Investigate the cause of the temperature deviation. Possible causes could include equipment malfunction, incorrect calibration, or environmental factors.
  3. Check the temperature control system components such as thermostats, temperature sensors, and controllers for proper operation. Verify that the system is properly calibrated and that the components are functioning as expected.
  4. If a malfunction is identified, take corrective action by repairing or replacing faulty parts. For minor issues, adjust the settings to bring the temperature back into the acceptable range.
  5. Once the issue is resolved, verify that the temperature is stable and within the required range. Document the issue and corrective action taken in the Temperature Deviation Log (Annexure-2).
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5.4 Calibration and Maintenance of Temperature Control Systems

  1. Perform regular calibration of temperature sensors and controllers at least once every six months or as per the manufacturer’s recommendation.
  2. Ensure that all calibration activities are documented in the Calibration Log (Annexure-3), including the calibration method, equipment used, and results obtained.
  3. Inspect and clean temperature control system components as part of the regular maintenance schedule to ensure accurate readings and proper function.
  4. Document all maintenance activities, including repairs, calibration, and any parts replaced, in the Equipment Maintenance Log (Annexure-4).

5.5 Post-Production Shutdown

  1. After production is complete, shut down the temperature control system according to the manufacturer’s guidelines.
  2. Ensure that all data from the temperature control system, including readings and calibration results, is properly saved and backed up for future reference.
  3. Record the final temperature reading at the end of production in the Temperature Control Log (Annexure-1).

5.6 Documentation and Record-Keeping

  1. Maintain accurate and complete records of all temperature checks, calibration, and maintenance activities. These records should be readily accessible for audits and inspections.
  2. Ensure that all temperature logs, calibration logs, and maintenance records are reviewed regularly by the Quality Assurance (QA) team to ensure compliance with GMP and internal quality standards.
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6. Abbreviations

7. Documents

  1. Annexure-1: Temperature Control Log
  2. Annexure-2: Temperature Deviation Log
  3. Annexure-3: Calibration Log
  4. Annexure-4: Equipment Maintenance Log

8. References

9. SOP Version

Version: 2.0

10. Approval Section

Prepared By Checked By Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Temperature Control Log

Batch Number Temperature (°C) Time Operator Comments
12345 25°C 10:00 AM John Doe Temperature within acceptable range

Annexure-2: Temperature Deviation Log

Deviation Date Batch Number Temperature Reading Corrective Action Taken Operator
21/01/2026 12345 28°C Adjusted machine settings, recalibrated sensor John Doe

Annexure-3: Calibration Log

Calibration Date Equipment ID Calibration Method Results Operator
20/01/2026 TCS-001 Manual Calibration with Certified Thermometer Pass Jane Smith

Annexure-4: Equipment Maintenance Log

Equipment ID Maintenance Date Maintenance Activity Operator Comments
TCS-001 21/01/2026 Routine Inspection John Doe No issues found

Revision History:

Revision Date Revision No. Revision Details Reason for Revision Approved By
01/03/2024 1.0 Initial Version New SOP Creation QA Head
01/03/2025 2.0 Format Revision and Updates Standardization of Document QA Head
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