Ensures that the long-term stability testing complies with local and international regulatory guidelines, including FDA, ICH, or other relevant authorities.

4. Accountability

The Manufacturing Manager is accountable for ensuring that the long-term stability studies are conducted as per this SOP. The overall compliance with this SOP is overseen by the Quality Assurance (QA) Manager.

5. Procedure

5.1. Preparation for Long-Term Stability Testing

1. The QA team will prepare the long-term stability study protocol, specifying the conditions to be applied (e.g., temperature, humidity, and duration). The conditions should be based on product characteristics and regulatory guidelines.
2. The products to be tested should be selected in consultation with the production and formulation teams. A representative batch of aerosol products should be chosen for testing.
3. The selected aerosol cans should be labeled and recorded according to their batch number, production date, and any other necessary identifiers.
4. The stability chambers or environmental test chambers should be calibrated to maintain the desired long-term storage conditions. Calibration records should be reviewed and verified (see Annexure-1: Calibration Log).
5. Ensure that the storage conditions (typically 25°C/60% RH or 30°C/65% RH for aerosol products) are appropriate for the product type and meet the regulatory requirements.

5.2. Conducting the Long-Term Stability Study

1. The selected aerosol products should be placed in the stability chambers under the pre-determined long-term conditions. The testing period should typically extend over a period of 12 months or longer, depending on the product and regulatory requirements.
2. Samples should be taken at regular intervals (e.g., 3 months, 6 months, 9 months, and 12 months) during the study for analysis.
3. During the study, environmental conditions (temperature and humidity) should be continuously monitored and documented. Any deviations from the set conditions should be reported and corrected immediately.
4. The stability chambers should be inspected regularly to ensure they are functioning properly and that the testing environment remains within the specified conditions.

5.3. Monitoring and Analyzing the Samples

1. At each time point, the samples should be removed from the stability chambers and analyzed for key quality attributes such as:
   • Appearance (e.g., color, clarity, aerosol can integrity)
   • Performance (e.g., spray rate, valve function, actuator performance)
   • Chemical composition (e.g., propellant concentration, formulation stability)
   • Physical properties (e.g., viscosity, pH if applicable)
2. The analysis results should be recorded in the Long-Term Stability Study Log (Annexure-2). Any changes observed in the product characteristics should be noted, and further analysis may be needed to investigate the cause of any significant changes.
3. If the products meet the required specifications at the end of the study, they will be considered stable for the period evaluated under long-term conditions.

5.4. Documentation and Record Keeping

1. All data generated from the long-term stability study, including environmental conditions, product performance, and laboratory analysis results, should be documented and stored securely.
2. Records should include:
   • Long-Term Stability Study Log (Annexure-2)
   • Calibration Log (Annexure-1)
   • Analysis and Test Results Log (Annexure-3)
3. The results should be reviewed by the QA team to ensure accuracy and completeness. Any discrepancies should be investigated and resolved before finalizing the stability report.
4. Documentation should be retained for a minimum of 3 years or as required by regulatory guidelines.

5.5. Reporting of Stability Study Results

1. The final stability study report should be prepared, including all observed data, analysis results, and conclusions about the stability of the aerosol products under long-term conditions.
2. The report should include recommendations for the shelf life of the product, based on the findings of the long-term stability study. If any products fail to meet the specifications, corrective actions or reformulations may be necessary.
3. The stability report should be reviewed and approved by the QA team and relevant departments (e.g., Regulatory Affairs, Production). 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
• ICH: International Council for Harmonisation
• CFR: Code of Federal Regulations

7. Documents

1. Long-Term Stability Study Log (Annexure-2)
2. Calibration Log (Annexure-1)
3. Analysis and Test Results 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
ST-001	01/02/2025	01/08/2025	Rajesh Patel	Calibrated and ready for use

Annexure-2: Long-Term Stability Study Log

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

Annexure-3: Analysis and Test Results Log

Batch Number	Test Type	Result	Operator Name	Test Date
Batch-001	Appearance	Pass	Rajesh Patel	10/02/2025

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