activities and ensuring corrective actions are taken when deviations are detected.

4. Accountability

The Production Manager is accountable for ensuring that real-time temperature monitoring is carried out as per this SOP. The QC Manager is responsible for validating temperature records and ensuring that corrective actions are implemented when necessary. The Laboratory Supervisor is responsible for supervising the temperature monitoring process and reviewing all temperature-related data.

5. Procedure

5.1 Pre-Production Setup

1. Review the batch manufacturing record (BMR) to confirm the required temperature specifications for the cream product being produced.
2. Ensure that the temperature monitoring system, including temperature probes, sensors, and data loggers, is properly calibrated and functioning before starting production.
3. Set up the temperature monitoring system in the processing equipment to ensure that temperature data is collected at the required intervals.
4. Ensure that the equipment used for temperature monitoring is placed in representative locations of the processing system, such as the mixing tank, emulsification unit, or heating/cooling units.

5.2 Real-Time Temperature Monitoring

1. Continuously monitor the temperature of the cream mixture during production using real-time temperature sensors or data loggers.
2. Ensure that temperature readings are taken and recorded at predetermined intervals (e.g., every 15 minutes) throughout the production process.
3. Ensure that the temperature remains within the acceptable range specified in the BMR or product specifications. Common temperature ranges for cream production are typically between 20°C and 35°C, but these may vary based on the specific formulation.
4. In case of automated monitoring, ensure that the system is logging temperature data automatically and sending alerts if the temperature falls outside the specified range.

5.3 Handling Temperature Deviations

1. If the temperature exceeds or falls below the acceptable range, immediately stop the production process and identify the cause of the deviation.
2. Common causes for temperature deviations include equipment malfunction, inadequate heating or cooling, or incorrect settings. Investigate the root cause and take corrective actions such as adjusting the heating or cooling system.
3. Document all temperature deviations, including the cause, corrective actions taken, and the impact on product quality, in the Deviation Report (Annexure-1).
4. If the deviation results in a significant change to the product, the batch may need to be rejected or reworked, as per the Batch Rework SOP (SOP/CRM/004/2025).

5.4 Post-Production Monitoring

1. After completing the production process, ensure that the temperature is monitored until the cream product has cooled to the desired storage temperature or is transferred to the filling line.
2. Ensure that the cooling phase is also monitored to verify that the temperature remains within the required range for product stability.
3. Ensure that the temperature monitoring system is stopped once the product has reached the appropriate temperature for storage or further processing.

5.5 Documentation and Record-Keeping

1. Record all temperature readings and any deviations in the Temperature Monitoring Log (Annexure-2).
2. Ensure that all records are signed by the operator performing the monitoring and reviewed by the Laboratory Supervisor.
3. Maintain all temperature monitoring records for a minimum of two years or as required by regulatory guidelines to ensure traceability and compliance during audits.
4. Ensure that all records are securely stored and readily available for review during internal audits or regulatory inspections.

6. Abbreviations

• GMP: Good Manufacturing Practices
• QC: Quality Control
• QA: Quality Assurance
• BMR: Batch Manufacturing Record
• PPE: Personal Protective Equipment
• °C: Degrees Celsius

7. Documents

1. Annexure-1: Deviation Report
2. Annexure-2: Temperature Monitoring 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
• FDA Guidance for Industry: Temperature Control in Pharmaceutical 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: Deviation Report

Batch Number	Deviation Description	Corrective Action	Resolved By
12345	Temperature exceeded limit	Adjusted cooling system	Jane Smith

Annexure-2: Temperature Monitoring Log

Batch Number	Time	Temperature (°C)	Operator	Remarks
12345	10:00 AM	23°C	John Doe	Within specification

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