particularly regarding the handling of aerosol products and the release of propellants or chemicals.

Research and Development (R&D) Team: Involved in the development of new aerosol formulations and adjusting the dissolution testing parameters to meet the specific characteristics of each formulation.

4. Accountability

The Manufacturing Manager is accountable for ensuring that dissolution tests are conducted on aerosol products to verify the performance and release characteristics. The overall compliance with this SOP is overseen by the Quality Assurance (QA) Manager.

5. Procedure

5.1. Pre-Test Preparation

1. Ensure that the aerosol products to be tested are fully manufactured, filled, and sealed according to product specifications.
2. Prepare the dissolution testing equipment, including:
   • Dissolution chamber or apparatus designed for aerosol-delivered products
   • Appropriate dissolution medium (e.g., simulated lung fluid or air) to simulate real-world conditions
   • PPE, including gloves, goggles, and lab coats
3. Verify that the testing environment is clean, sterile, and free from contamination. Calibrate the dissolution testing equipment according to the manufacturer’s specifications and company procedures.

5.2. Conducting the Dissolution Test

1. Place the aerosol product (e.g., spray can or inhaler) into the dissolution chamber according to the type of test being performed.
2. Activate the aerosol product under controlled conditions to release the active ingredient(s). Ensure that the test conditions, such as air flow, temperature, and humidity, replicate real-world usage scenarios.
3. Monitor the amount of active ingredient released over time. For aerosol products, this may involve collecting a specified volume of aerosol or measuring the concentration of active ingredients in the air over a given time period.
4. Record the amount of active ingredient released at specified intervals (e.g., 5, 10, 15, 30 minutes) to construct a dissolution profile.
5. Ensure that the dissolution profile matches the predefined release specifications (e.g., the percentage of the active ingredient released within a certain time frame).

5.3. Post-Test Actions

1. If the aerosol product passes the dissolution test:
   • Proceed with the next step in the production process, ensuring that all products meet the dissolution requirements.
   • Document the test results, including the test date, sample ID, operator name, and dissolution profile, in the Dissolution Test Log (Annexure-1).
2. If the aerosol product fails the dissolution test (e.g., insufficient release, incomplete dissolution), investigate potential causes (e.g., formulation issues, actuator malfunction) and take corrective action.
3. Notify the QC team and relevant personnel of the failure, and document corrective actions taken in the Corrective Action Log (Annexure-2).

5.4. Calibration and Maintenance of Equipment

1. Ensure that all dissolution testing equipment is calibrated according to the manufacturer’s specifications and company procedures.
2. Perform routine maintenance on the dissolution testing apparatus, including cleaning, checking for wear, and replacing any faulty components to ensure accurate results.
3. Document all calibration and maintenance activities in the Equipment Calibration Log (Annexure-3) and the Equipment Maintenance Log (Annexure-4).

5.5. Documentation and Record-Keeping

1. Document all dissolution testing activities, including the test results, sample details, operator name, and any corrective actions taken, in the Dissolution Test Log (Annexure-1).
2. Ensure that all records are reviewed by the QC team to confirm that the aerosol product meets the required dissolution specifications.
3. Store all records in the document management system, ensuring they are available for future reference and audits.

5.6. Safety and Environmental Considerations

1. Ensure that all personnel involved in dissolution testing wear appropriate PPE, including gloves, goggles, and lab coats, to prevent exposure to aerosols and propellants.
2. Conduct all testing in a well-ventilated area, preferably in a fume hood or with proper exhaust systems, to prevent the buildup of propellant vapors or other potentially harmful gases.
3. Dispose of any waste generated during testing, including used formulations, contaminated equipment, and aerosols, according to safety and environmental regulations.

6. Abbreviations

• GMP: Good Manufacturing Practice
• QC: Quality Control
• PPE: Personal Protective Equipment
• SOP: Standard Operating Procedure
• LOD: Limit of Detection

7. Documents

1. Dissolution Test Log (Annexure-1)
2. Corrective Action Log (Annexure-2)
3. Equipment Calibration Log (Annexure-3)
4. Equipment Maintenance 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
• ISO 9001:2015 – Quality Management Systems
• International Conference on 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: Dissolution Test Log

Formulation ID	Test Date	Test Method	Result	Operator Name	Remarks
FORM-12345	06/02/2025	Spray Test	Pass	Rajesh Patel	No issues found

Annexure-2: Corrective Action Log

Can ID	Issue Date	Issue Description	Corrective Action	Operator Name
FORM-12346	06/02/2025	Inconsistent release rate	Reformulated to improve release profile	Rajesh Patel

Annexure-3: Equipment Calibration Log

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Equipment ID	Calibration Date	Calibration Results	Operator Name	Remarks
TEST-001	06/02/2025	Pass	Rajesh Patel	No adjustments required

Annexure-4: Equipment Maintenance Log

Equipment ID	Maintenance Date	Tasks Performed	Operator Name	Remarks
TEST-001	06/02/2025	Cleaned and calibrated	Rajesh Patel	No issues found

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