testing conditions, and recording data during the study.

Regulatory Affairs Team: Ensures that the stability testing complies with applicable regulatory guidelines, such as ICH and FDA standards, and verifies that the test protocols meet the requirements for approval.

4. Accountability

The Manufacturing Manager is accountable for ensuring that the stability testing of actuators and valves is conducted according to this SOP. The overall compliance with this SOP is overseen by the Quality Assurance (QA) Manager.

5. Procedure

5.1. Selection of Actuators and Valves for Testing

1. The stability testing team will select representative samples of actuators and valves for the stability tests. These samples should be from different batches to ensure the results are representative of the entire production lot.
2. The selected actuators and valves must be fully assembled and properly installed in the aerosol cans for the test, with the formulation to be used for the test.
3. The materials for testing should include all components that will be used in the final product, including the valve body, actuator, dip tube, and any gaskets or seals.

5.2. Setting Up Stability Testing Conditions

1. The stability testing of actuators and valves will be conducted under the following conditions:
   • Standard stability conditions (e.g., 25°C/60% RH) and accelerated conditions (e.g., 40°C/75% RH) will be used to simulate long-term and short-term storage environments.
   • Samples will be subjected to multiple cycles of actuation to simulate the dispensing process over the product’s shelf life.
2. The stability chambers should be calibrated to ensure they maintain the specified temperature and humidity conditions. Calibration records should be reviewed and verified (see Annexure-1: Calibration Log).

5.3. Testing Parameters for Actuators and Valves

1. During the stability study, the following parameters should be monitored for actuators and valves:
   • Functionality: Ensure that the actuator and valve continue to operate effectively, dispensing the correct amount of product with each actuation.
   • Leakage: Check for any leakage from the valve or actuator, which could compromise product integrity.
   • Physical Integrity: Inspect the actuator and valve for any signs of wear, corrosion, or deformation.
   • Performance: Test the spray rate, consistency, and spray pattern to ensure that it remains within the specified limits.
2. The results of each parameter should be recorded in the Actuator and Valve Stability Test Log (Annexure-2).

5.4. Monitoring and Recording Data

1. Throughout the testing period, the stability testing team should monitor and record the following:
   • Temperature and humidity levels in the stability chamber
   • The number of actuations performed at each test interval
   • The performance data, including spray rate, valve function, and leakage
2. Data should be recorded at regular intervals, e.g., at 1-month, 3-month, and 6-month intervals for intermediate stability studies. For long-term studies, sampling may occur at longer intervals.
3. All data should be documented in the Actuator and Valve Stability Test Log (Annexure-2). Any deviations from the specified test conditions should be documented in the Deviation Log (Annexure-3).

5.5. Reporting and Analysis of Results

1. At the end of the stability study, the testing team will compile the results into a stability report. The report should include:
   • The performance of the actuators and valves under the tested conditions
   • Any observed degradation or failure in the components, such as leaks, functional issues, or physical damage
   • Recommendations for the shelf life based on the observed performance of the actuators and valves
2. If any actuators or valves fail during the stability test, the cause should be investigated, and corrective actions should be implemented. A root cause analysis should be conducted, and the corrective actions should be documented in the Corrective Action Log (Annexure-4).
3. The final stability report should be reviewed and approved by the QA team and other relevant departments (e.g., 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
• ACT: Actuator
• VAL: Valve

7. Documents

1. Actuator and Valve Stability Test Log (Annexure-2)
2. Calibration Log (Annexure-1)
3. Deviation Log (Annexure-3)
4. Corrective Action Log (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: Calibration Log

Equipment ID	Calibration Date	Next Calibration Due	Operator Name	Remarks
ST-003	01/02/2025	01/05/2025	Rajesh Patel	Calibrated and ready for use

Annexure-2: Actuator and Valve Stability Test Log

Batch Number	Test Date	Temperature	Humidity	Actuation Count	Operator Name	Remarks
Batch-001	10/02/2025	40°C	75%	1000	Rajesh Patel	Functioning within specifications

Annexure-3: Deviation Log

Deviation ID	Deviation Description	Corrective Action	Responsible Person	Status
DEV-54321	Valve leakage detected	Replaced valve and re-tested	Rajesh Patel	Completed

Annexure-4: Corrective Action Log

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

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