data for compliance purposes.

Quality Assurance (QA): Ensures that temperature control processes are followed according to this SOP, reviews temperature logs, and approves deviations or corrective actions if necessary.

Maintenance Team: Responsible for ensuring that temperature control equipment (e.g., thermostats, temperature sensors) is functioning correctly and calibrated regularly.

4. Accountability

The Head of Creams Manufacturing is responsible for ensuring that this SOP is implemented across the manufacturing process. The QA Manager is accountable for reviewing temperature logs, ensuring compliance with the temperature control process, and approving any deviations.

5. Procedure

5.1 Pre-Operation Checks

1. Ensure that all temperature control equipment, such as temperature sensors, controllers, and thermometers, are calibrated and functioning correctly.
2. Verify that the temperature control systems are set to the correct values based on the process requirements for each cream formulation.
3. Check that the production area is pre-heated or pre-cooled as required for the specific batch being produced.
4. Inspect all mixing and processing equipment to ensure that it is clean and ready for use, with all necessary components properly installed.

5.2 Temperature Control during Heating

1. Gradually heat the ingredients to the required temperature, ensuring that the heating process is controlled to prevent overheating or degradation of ingredients.
2. Use appropriate heating methods (e.g., steam, electrical heating) depending on the type of ingredients being processed and ensure that the temperature does not exceed the maximum recommended temperature for each ingredient.
3. Continuously monitor the temperature during heating, using both automated systems and manual checks. Record the temperature at regular intervals in the Heating Temperature Log (Annexure-1).
4. If the temperature exceeds the specified range, stop the heating process immediately and investigate the cause. Implement corrective actions before resuming heating.

5.3 Temperature Control during Mixing

1. Once the ingredients have been heated to the desired temperature, transfer them to the mixing vessel. Ensure that the mixing process maintains the required temperature throughout.
2. During mixing, monitor the temperature to ensure it remains within the desired range. Adjust heating or cooling as necessary to maintain consistency and prevent overheating.
3. Record the temperature in the Mixing Temperature Log (Annexure-2) at regular intervals, particularly during key stages of the mixing process.
4. If the temperature deviates from the specified range, immediately stop the process and address the issue before proceeding.

5.4 Temperature Control during Cooling

1. Once mixing is complete, begin the cooling process according to the formulation’s requirements. Use cooling systems or ambient air to bring the temperature down to the desired level.
2. Ensure that the cooling process is gradual and controlled to prevent rapid temperature fluctuations that could affect the product’s quality.
3. Monitor the temperature during cooling and record it at key intervals in the Cooling Temperature Log (Annexure-3). Continue monitoring until the product reaches the required storage temperature.
4. If any deviation occurs during cooling, stop the process and investigate the cause. Make the necessary adjustments before resuming.

5.5 Temperature Control during Storage

1. After cooling, store the cream at the required temperature to maintain its stability and prevent microbial growth or texture changes.
2. Use temperature-controlled storage units, such as refrigerators or insulated tanks, to store the cream until it is ready for packaging.
3. Continuously monitor the storage temperature and document it in the Storage Temperature Log (Annexure-4). Record the temperature at regular intervals, particularly when the cream is being moved between storage areas or processes.
4. Ensure that the storage area is maintained at the specified temperature range at all times. If the temperature falls outside the acceptable range, notify the QA team immediately for corrective actions.

5.6 Documentation

1. Complete the Temperature Control Logs (Annexures 1–4) for each process step, including heating, mixing, cooling, and storage. Ensure that all temperature readings are recorded accurately and signed by the operator.
2. If any temperature deviations occur during the process, document them in the Deviation Report Form (Annexure-5) and follow the deviation handling process.
3. Review the temperature logs periodically to ensure compliance with the required temperature ranges and GMP standards.

5.7 Corrective Actions

1. If a temperature deviation occurs during any stage of processing, stop the operation immediately. Investigate the cause of the deviation and determine corrective actions.
2. Once the issue is resolved, document the corrective actions taken in the Corrective Action Log (Annexure-6).
3. After implementing corrective actions, resume the process and continue to monitor the temperature to ensure that it remains within the required range.

5.8 Final Approval

1. The QA team must review the temperature logs and ensure that the temperature control procedures have been followed correctly before approving the batch for the next stage of manufacturing.

6. Abbreviations

• QC: Quality Control
• QA: Quality Assurance
• GMP: Good Manufacturing Practices
• PPE: Personal Protective Equipment

7. Documents

1. Heating Temperature Log (Annexure-1)
2. Mixing Temperature Log (Annexure-2)
3. Cooling Temperature Log (Annexure-3)
4. Storage Temperature Log (Annexure-4)
5. Deviation Report Form (Annexure-5)
6. Corrective Action Log (Annexure-6)

8. References

• Good Manufacturing Practices (GMP) Guidelines – 21 CFR Part 211
• International Conference on Harmonisation (ICH) Q7 – Good Manufacturing Practice for Active Pharmaceutical Ingredients
• FDA Guidelines for Cosmetics Manufacturing

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Heating Temperature Log

Batch Number	Start Time	End Time	Temperature (°C)	Operator	Comments
12345	08:00 AM	09:00 AM	75°C	Jane Smith	No issues

Annexure-2: Mixing Temperature Log

Batch Number	Start Time	End Time	Temperature (°C)	Operator	Comments
12345	09:30 AM	10:30 AM	70°C	John Doe	No issues

Annexure-3: Cooling Temperature Log

Batch Number	Start Time	End Time	Temperature (°C)	Operator	Comments
12345	11:00 AM	12:00 PM	25°C	Jane Smith	No issues

Annexure-4: Storage Temperature Log

Batch Number	Storage Start Time	Storage End Time	Temperature (°C)	Operator	Comments
12345	12:30 PM	01:30 PM	4°C	John Doe	No issues

Annexure-5: Deviation Report Form

Deviation Description	Time	Batch Number	Operator	Immediate Action
Temperature deviation during cooling	12:15 PM	12345	Jane Smith	Adjusted cooling time

Annexure-6: Corrective Action Log

Issue	Root Cause	Corrective Action	Completion Date
Temperature fluctuation during mixing	Improper setting of thermostat	Re-calibrated thermostat	02/01/2026

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