that they are correctly labeled and documented prior to stability testing.

4. Accountability

The Manufacturing Manager is accountable for ensuring that the stability testing results are documented according to this SOP. The overall compliance with this SOP is overseen by the Quality Assurance (QA) Manager.

5. Procedure

5.1. Documentation of Stability Test Data

1. During the stability study, all observations, measurements, and test results should be recorded accurately. This includes:
   • Temperature and humidity levels in the stability chambers
   • Product performance (e.g., appearance, functionality, spray rate, valve operation)
   • Chemical and physical tests (e.g., active ingredient concentration, viscosity, pH)
2. Data should be recorded in the Stability Testing Results Log (Annexure-1) in a consistent and legible manner, with all fields filled in completely. Any deviations or anomalies in the data should be clearly marked and documented with an explanation in the Deviation Log (Annexure-2).
3. All results should be dated and signed by the responsible personnel. If data entry is done electronically, it must be validated and backed up regularly to ensure the integrity of the records.

5.2. Handling of Deviations and Anomalies

1. If any deviations from the planned stability testing conditions are observed, they should be recorded in the Deviation Log (Annexure-2). The following steps should be taken:
   • Investigate the cause of the deviation (e.g., equipment malfunction, incorrect product handling, environmental control failure).
   • Assess whether the deviation could affect the integrity of the stability results.
   • Implement corrective actions as necessary, and document the actions taken in the Corrective Action Log (Annexure-3).
2. The QA team should review any deviations to ensure appropriate actions are taken and that the integrity of the stability study is maintained.

5.3. Analysis and Review of Results

1. After the stability study is completed, the results should be reviewed by the QA team. The analysis should include:
   • Comparing the results against predefined acceptance criteria for stability (e.g., appearance, chemical composition, performance).
   • Identifying any significant changes in the product that may indicate instability.
   • Assessing the data in relation to the intended shelf life and the stability conditions under which the product was tested.
2. If the results meet the specified stability criteria, the product can be approved for further processing or release. If there are deviations, the product may need further testing, adjustments, or re-evaluation.

5.4. Reporting of Stability Testing Results

1. Upon completion of the stability study and analysis of results, a formal report should be prepared, which includes:
   • The objectives and scope of the stability study
   • Test conditions and results for each time point and sample
   • Any deviations or anomalies observed during the study
   • Conclusions regarding product stability and shelf life
2. The stability report should be reviewed by the QA team and other relevant departments (e.g., Regulatory Affairs, Production). Once approved, it should be stored in the company’s records for future reference and regulatory compliance.
3. The report should also include recommendations for the product’s shelf life, storage conditions, and any additional stability testing that may be needed.

5.5. Documentation Storage and Retention

1. All stability testing results, including raw data, test logs, deviation records, and final reports, should be stored securely in both electronic and/or physical formats. These records should be accessible for internal audits and external regulatory inspections.
2. Stability testing records should be retained for a minimum of 3 years or as required by regulatory guidelines, whichever is longer.

6. Abbreviations

• GMP: Good Manufacturing Practice
• QA: Quality Assurance
• SOP: Standard Operating Procedure
• RH: Relative Humidity
• ACT: Actuator
• VAL: Valve
• CAPA: Corrective and Preventive Action

7. Documents

1. Stability Testing Results Log (Annexure-1)
2. Deviation Log (Annexure-2)
3. Corrective Action Log (Annexure-3)
4. Stability Testing Report (Annexure-4)

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: Stability Testing Results Log

Batch Number	Test Date	Test Results	Operator Name	Remarks
Batch-001	10/02/2025	Pass	Rajesh Patel	No deviations

Annexure-2: Deviation Log

Deviation ID	Deviation Description	Corrective Action	Responsible Person	Status
DEV-12345	Temperature deviation detected	Re-calibrated equipment and re-tested	Rajesh Patel	Completed

Annexure-3: Corrective Action Log

Action ID	Action Description	Assigned To	Completion Date	Remarks
ACT-12345	Replaced faulty actuator	Rajesh Patel	10/02/2025	Action completed successfully

Annexure-4: Stability Testing Report

Batch Number	Test Date	Results Summary	Operator Name	Final Conclusion
Batch-001	10/02/2025	Passed stability tests	Rajesh Patel	Approved for release

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