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
- Production Team: Responsible for ensuring that temperature control systems are operating within the specified range during production. They are also responsible for reporting any temperature deviations to the Maintenance Team.
- Maintenance Team: Responsible for performing regular maintenance, calibration, and troubleshooting of temperature control systems to ensure their proper functioning.
- Quality Control (QC): Responsible for verifying that temperature control systems are operating within acceptable limits and ensuring that all necessary records are maintained.
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.
5. Procedure
5.1 Daily Operational Checks
- 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.
- Verify that all temperature sensors, gauges, and controllers are functioning correctly. Ensure that the display panels show the correct readings.
- Check the calibration of the temperature control system by comparing the readings with a certified thermometer or other approved devices.
- 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
- Monitor the temperature of the production equipment (e.g., mixers, homogenizers) continuously throughout the production process.
- 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.
- 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.
- Perform random checks of the temperature at various points in the production line to ensure uniformity.
- 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
- If the temperature deviates from the specified range, stop the production process immediately to prevent product quality issues.
- Investigate the cause of the temperature deviation. Possible causes could include equipment malfunction, incorrect calibration, or environmental factors.
- 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.
- 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.
- 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).
5.4 Calibration and Maintenance of Temperature Control Systems
- Perform regular calibration of temperature sensors and controllers at least once every six months or as per the manufacturer’s recommendation.
- Ensure that all calibration activities are documented in the Calibration Log (Annexure-3), including the calibration method, equipment used, and results obtained.
- Inspect and clean temperature control system components as part of the regular maintenance schedule to ensure accurate readings and proper function.
- Document all maintenance activities, including repairs, calibration, and any parts replaced, in the Equipment Maintenance Log (Annexure-4).
5.5 Post-Production Shutdown
- After production is complete, shut down the temperature control system according to the manufacturer’s guidelines.
- Ensure that all data from the temperature control system, including readings and calibration results, is properly saved and backed up for future reference.
- Record the final temperature reading at the end of production in the Temperature Control Log (Annexure-1).
5.6 Documentation and Record-Keeping
- Maintain accurate and complete records of all temperature checks, calibration, and maintenance activities. These records should be readily accessible for audits and inspections.
- 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.
6. Abbreviations
- GMP: Good Manufacturing Practices
- QC: Quality Control
- QA: Quality Assurance
- PPE: Personal Protective Equipment
7. Documents
- Annexure-1: Temperature Control Log
- Annexure-2: Temperature Deviation Log
- Annexure-3: Calibration Log
- Annexure-4: Equipment Maintenance Log
8. References
- Good Manufacturing Practices (GMP) Guidelines – 21 CFR Part 211
- International Conference on Harmonisation (ICH) Q7 – Good Manufacturing Practice for Active Pharmaceutical Ingredients
- Manufacturer’s Manual for Temperature Control Systems
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 |