ensuring that the validation meets regulatory standards and GMP requirements.

Maintenance Team: Responsible for maintaining the temperature sensors and performing corrective actions if any issues are detected during the validation process.

4. Accountability

The Manufacturing Manager is accountable for ensuring that the temperature sensor validation process is conducted and documented in compliance with this SOP. The overall compliance with this SOP is overseen by the Quality Assurance (QA) Manager.

5. Procedure

5.1. Preparing for Temperature Sensor Validation

1. Before starting the validation process, ensure that all temperature sensors are installed correctly and in their designated locations. Verify that the sensors are properly connected to the measurement system and that the system is operational.
2. Ensure that all necessary calibration equipment is available, including calibration thermometers, standard reference materials, and temperature-controlled baths or ovens.
3. Verify that the temperature sensors are clean and free from any contaminants or damage before conducting the validation.
4. Review the manufacturer’s specifications for the temperature sensors to understand the required calibration methods, acceptable tolerance limits, and the performance characteristics of the sensors.
5. Establish the validation team, which should include representatives from the Engineering, Production, and QA teams.

5.2. Conducting the Temperature Sensor Validation

1. Perform the following tests as part of the temperature sensor validation process:
   • Calibration Test: Use a calibrated reference thermometer or temperature calibration device to measure the temperature at several points across the sensor’s operational range. The temperature sensor readings should be compared to the reference thermometer readings to verify accuracy.
   • Accuracy Test: Test the temperature sensor by measuring known temperature standards (e.g., ice water at 0°C and boiling water at 100°C) to ensure that the sensor provides accurate readings under controlled conditions.
   • Repeatability Test: Repeat the calibration test multiple times to ensure that the sensor consistently provides the same readings under the same conditions.
   • Linear Range Test: Verify that the temperature sensor provides consistent and linear readings across its specified temperature range. Use known temperature standards to confirm the sensor’s linearity.
   • Environmental Testing: Verify that the temperature sensor operates correctly under the environmental conditions in which it will be used (e.g., ambient temperature, humidity). Ensure that the sensor’s performance is not affected by factors outside the specified operating range.
2. Record all test results, including the test conditions, measured values, and any deviations observed. Document the calibration, accuracy, and repeatability results in the Temperature Sensor Validation Report (Annexure-1).

5.3. Documenting the Validation Results

1. Document the following information in the Temperature Sensor Validation Report (Annexure-1):
   • Details of the temperature sensor, including the model, serial number, and installation location
   • The reference calibration standards used for testing
   • The results of each validation test (e.g., calibration, accuracy, repeatability, linear range)
   • The name and signature of the personnel who performed the validation tests
   • The date and time of testing
2. Ensure that the validation report is signed and approved by the responsible personnel (e.g., Engineering, Production, and QA teams).

5.4. Reviewing and Approving the Validation Report

1. The QA team should review the Temperature Sensor Validation Report to ensure that all tests have been conducted according to the protocol and that the sensor meets the required accuracy and performance specifications.
2. If any deviations are observed during the validation process, they should be documented in the Deviation Log (Annexure-2), and corrective actions should be taken.
3. The QA team should approve the report once all validation activities are complete and any deviations have been addressed.

5.5. Finalizing the Validation Process

1. Once the temperature sensor is validated, it is considered ready for use in the aerosol manufacturing process. The validated sensor can be used for ongoing temperature monitoring and control during production.
2. All documentation, including the Temperature Sensor Validation Report, Deviation Log, and any corrective actions, should be archived for future audits and inspections.
3. Periodic revalidation and calibration activities should be scheduled as per the manufacturer’s recommendations and regulatory requirements.

6. Abbreviations

• GMP: Good Manufacturing Practice
• QA: Quality Assurance
• SOP: Standard Operating Procedure
• CAPA: Corrective and Preventive Action
• OQ: Operational Qualification
• PQ: Performance Qualification
• IQ: Installation Qualification

7. Documents

1. Temperature Sensor Validation Report (Annexure-1)
2. Deviation Log (Annexure-2)

8. References

This SOP is based on the following regulatory guidelines and industry standards:

• Good Manufacturing Practice (GMP) Guidelines
• FDA Code of Federal Regulations (CFR) Title 21, Part 211
• International Council for Harmonisation (ICH) Guidelines

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 Sensor Validation Report

Sensor ID	Model Number	Serial Number	Test Date	Test Type	Result
TS-001	Model X	SN123456	06/02/2025	Calibration Test	Pass
TS-001	Model X	SN123456	06/02/2025	Accuracy Test	Pass

Annexure-2: Deviation Log

Deviation ID	Deviation Description	Corrective Action	Assigned To	Status
DEV-12345	Temperature sensor inaccurate	Recalibrated sensor	Rajesh Patel	Completed

12. Revision History:

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By	Page No.	Ref. Point No.	Details of Revision
01/01/2024	V 1.0	Initial Release	First Issue	Anjali Sharma	Page 1	[Ref Point]	First Release
01/01/2025	V 2.0	Updated temperature validation procedures	To comply with updated GMP regulations	Anjali Sharma	Page 1	[Ref Point]	Updated procedures