under the correct conditions and for recording any deviations in environmental conditions during testing.

Regulatory Affairs Team: Ensures compliance with applicable regulatory guidelines, including FDA, ICH, and GMP standards, for temperature and humidity monitoring during stability studies.

4. Accountability

The Manufacturing Manager is accountable for ensuring that the temperature and humidity monitoring processes are conducted as per this SOP. The overall compliance with this SOP is overseen by the Quality Assurance (QA) Manager.

5. Procedure

5.1. Calibration of Stability Chambers

1. Stability chambers should be calibrated regularly to ensure accurate temperature and humidity measurements. Calibration should be performed by trained personnel using certified calibration equipment.
2. Calibration records should be documented in the Calibration Log (Annexure-1). All equipment used for calibration should be traceable to national standards, and the calibration should be conducted annually or as per the manufacturer’s guidelines.
3. Any discrepancies identified during the calibration process should be addressed immediately. The stability chamber should not be used for testing until the calibration has been successfully completed.

5.2. Monitoring Temperature and Humidity

1. The temperature and humidity in the stability chamber must be monitored continuously. Electronic data loggers or controllers should be installed to record the temperature and humidity levels at set intervals (e.g., every 15 minutes).
2. Temperature should be maintained within the specified range (e.g., 25°C ± 2°C or 30°C ± 2°C for accelerated conditions), and humidity should be within the range of 60-75% RH, depending on the test requirements.
3. Data should be automatically logged and stored in a secure system for future reference and regulatory audits. Manual readings can be recorded as backup if required by the regulatory body or if electronic systems fail.
4. Temperature and humidity conditions should be checked daily to ensure they remain within the specified limits. If the temperature or humidity falls outside of the specified range, corrective actions should be taken immediately, and the incident should be documented in the Deviation Log (Annexure-2).

5.3. Handling Temperature or Humidity Deviations

1. If a deviation in temperature or humidity occurs, the following actions should be taken:
   • Investigate the cause of the deviation (e.g., malfunctioning equipment, power failure, or door left open).
   • Document the incident in the Deviation Log (Annexure-2), including the details of the deviation, its cause, and the corrective actions taken.
   • Determine whether the deviation impacts the stability study and whether any samples need to be retested or removed from the study.
   • Ensure that the stability chamber is returned to the proper conditions before resuming testing, and confirm the chamber’s stability is within range before continuing to use it for stability studies.
2. Any deviations should be reviewed by the QA team and addressed according to the company’s corrective and preventive action (CAPA) procedures.

5.4. Documentation and Record Keeping

1. Temperature and humidity monitoring records should be maintained for each stability study. Records should include:
   • Temperature and humidity readings at specified intervals
   • Calibration records for temperature and humidity monitoring equipment
   • Deviation logs, including corrective actions taken
2. All records should be signed and dated by the responsible personnel and stored securely. Documentation should be retained for a minimum of 3 years or as required by regulatory guidelines.
3. Temperature and humidity logs should be reviewed periodically by the QA team to ensure compliance with the specified conditions.

5.5. Reporting and Compliance

1. If any significant deviations in temperature or humidity are observed during stability testing, a report should be prepared and submitted to the QA team. The report should include:
   • A detailed description of the deviation
   • The impact of the deviation on the stability testing process
   • Any corrective actions taken
2. Reports should be reviewed and approved by the QA team and relevant departments (e.g., Production, Regulatory Affairs). The finalized report should be stored in the company’s records for regulatory compliance and future reference.

6. Abbreviations

• GMP: Good Manufacturing Practice
• QA: Quality Assurance
• SOP: Standard Operating Procedure
• RH: Relative Humidity
• CFR: Code of Federal Regulations
• CAPA: Corrective and Preventive Action

7. Documents

1. Calibration Log (Annexure-1)
2. Deviation Log (Annexure-2)
3. Temperature and Humidity Monitoring Log (Annexure-3)

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: Calibration Log

Equipment ID	Calibration Date	Next Calibration Due	Operator Name	Remarks
TC-001	01/02/2025	01/08/2025	Rajesh Patel	Calibrated and ready for use

Annexure-2: Deviation Log

Deviation ID	Deviation Description	Corrective Action	Responsible Person	Status
DEV-12345	Temperature deviation detected	Corrected temperature settings and re-checked conditions	Rajesh Patel	Completed

Annexure-3: Temperature and Humidity Monitoring Log

Batch Number	Test Date	Temperature	Humidity	Operator Name	Remarks
Batch-001	10/02/2025	25°C	60%	Rajesh Patel	Stable under test conditions

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 monitoring procedures	To comply with updated GMP regulations	Anjali Sharma	Page 1	[Ref Point]	Updated procedures