performed safely, with all necessary safety precautions in place, particularly when handling volatile or hazardous materials.

4. Accountability

The Manufacturing Manager is accountable for ensuring that this SOP is followed during the homogenization process. The overall compliance with this SOP is under the supervision of the Quality Assurance (QA) Manager.

5. Procedure

5.1. Preparation of Ingredients

1. Verify that all ingredients, including active ingredients, excipients, and propellants (if applicable), are correctly weighed and ready for the homogenization process.
2. Ensure that the ingredients are free of contaminants and that they are compatible with each other and with the homogenization equipment.
3. Preheat or cool the ingredients as necessary to ensure that they are at the optimal temperature for mixing. This is particularly important for suspensions and emulsions.

5.2. Selection of Homogenization Equipment

1. Select the appropriate homogenization equipment based on the formulation type and batch size. Common equipment includes:
   • High-shear mixers
   • Ultrasonic homogenizers
   • Rotor-stator homogenizers
2. Verify that the equipment is clean, calibrated, and in good working condition before use. Ensure that the equipment is suitable for the formulation’s viscosity and the desired level of dispersion.
3. Ensure that the equipment has been tested for compliance with GMP guidelines and that maintenance schedules are up-to-date.

5.3. Homogenization Process

1. Load the ingredients into the homogenizer in the correct order, ensuring that the formulation is not contaminated during this process.
2. Begin the homogenization process at a low speed to allow for proper mixing of the components. Gradually increase the speed to the recommended level for the specific formulation and homogenizer type.
3. Monitor the temperature of the mixture during the homogenization process to ensure it does not exceed the recommended limits. If necessary, use a cooling system to prevent overheating of sensitive ingredients.
4. Homogenize the mixture until the desired consistency and uniformity are achieved. This may require several passes through the homogenizer to ensure that all components are evenly dispersed.
5. For emulsions or suspensions, ensure that the particle size distribution is within the required specifications, as this is critical for the product’s performance and stability.

5.4. In-Process Testing and Monitoring

1. Perform in-process testing to ensure that the formulation is homogeneous and meets all specifications. Common tests include:
   • Viscosity measurement
   • Particle size analysis (for suspensions and emulsions)
   • Uniformity testing
2. Record the results of the in-process testing in the In-Process Testing Log (Annexure-1). If any deviations are observed, investigate the root cause and adjust the process accordingly.
3. If the formulation is not homogeneous, repeat the homogenization process or adjust the equipment settings (e.g., speed, time, temperature) to improve uniformity.

5.5. Post-Homogenization Procedure

1. After homogenization is complete, allow the formulation to cool (if applicable) before transferring it to the next phase of production (e.g., filling or stability testing).
2. Ensure that the formulation meets all final product specifications, including consistency, particle size distribution, and performance characteristics.
3. If the formulation passes all specifications, document the results in the Batch Record and In-Process Testing Log (Annexure-1).
4. Transfer the homogeneous formulation to the packaging area or store it for stability testing, depending on the next step in the manufacturing process.

5.6. Safety and Environmental Considerations

1. Ensure that all operators are wearing the appropriate personal protective equipment (PPE), such as gloves, safety goggles, and lab coats, to minimize exposure to hazardous chemicals or propellants.
2. Ensure that the homogenization area is well-ventilated to prevent the accumulation of volatile fumes. If necessary, use fume hoods or exhaust systems.
3. Ensure that the homogenization equipment is regularly maintained to prevent malfunctions or safety hazards.

5.7. Documentation and Record-Keeping

1. Document all steps in the Homogenization Log (Annexure-2), including the equipment used, formulation details, operator information, and any adjustments or deviations during the process.
2. Ensure that the In-Process Testing Log (Annexure-1) is completed with all test results, including viscosity, particle size, and uniformity testing results.
3. Ensure that all batch records are stored according to the company’s document retention policy and are available for review during audits or inspections.

6. Abbreviations

• GMP: Good Manufacturing Practice
• QC: Quality Control
• CAPA: Corrective and Preventive Actions
• PPE: Personal Protective Equipment
• R&D: Research and Development

7. Documents

1. Homogenization Log (Annexure-2)
2. In-Process Testing Log (Annexure-1)

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 Pharmacopoeia (Ph. Int.) – Aerosol Delivery

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: In-Process Testing Log

Test Parameter	Test Result	Test Date	Tested By
Viscosity	Pass	06/02/2025	Rajesh Patel

Annexure-2: Homogenization Log

Batch No.	Formulation	Equipment Used	Operator Name	Comments
12345	Example Aerosol	High-Shear Mixer	Rajesh Patel	No issues

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