meets regulatory and product quality standards.

Production Team: Responsible for carrying out the homogenization process according to the formulation guidelines and SOP, ensuring that the required parameters (e.g., pressure, temperature, mixing time) are met.

4. Accountability

The Head of Creams Manufacturing is responsible for overseeing the homogenization process and ensuring that all equipment and personnel are ready for the procedure. The QA Manager is accountable for ensuring compliance with this SOP and that the final cream product meets the required quality standards.

5. Procedure

5.1 Preparation of Ingredients

1. Ensure that the cream formulation has been properly emulsified before the homogenization process begins. The emulsion should have reached a uniform consistency, and all phases should be fully blended.
2. Ensure that all active ingredients and excipients are properly incorporated into the cream base, and the mixture is free from large particulates or visible separation.
3. Verify that all raw materials are within specification and that no adjustments to the formulation are required before homogenization.

5.2 Preparation of Homogenization Equipment

1. Before beginning the homogenization process, ensure that the homogenizer or high-shear mixer is properly cleaned and calibrated according to the cleaning and maintenance SOP.
2. Check that the homogenizer is functioning correctly and that the required pressure and speed settings are available for the intended homogenization process.
3. Confirm that the homogenization vessel is clean, appropriately sized for the batch, and free from contaminants.
4. Set up the necessary equipment for monitoring temperature, viscosity, and pressure during the homogenization process.

5.3 Homogenization Process

1. Transfer the cream formulation into the homogenization vessel and begin mixing gently to reduce the risk of air entrapment or excessive foam formation.
2. Gradually increase the homogenization pressure and speed according to the formulation’s requirements, as specified in the MFR. Typical pressure settings range from 1000 psi to 5000 psi, depending on the desired texture and formulation.
3. Monitor the temperature of the mixture to ensure that it does not exceed the recommended range (usually between 40°C and 60°C) to prevent degradation of heat-sensitive ingredients.
4. Continue the homogenization process until the cream reaches the desired consistency and particle size distribution. The ideal particle size range is typically below 5 microns for optimal texture and stability.
5. Once the desired consistency is achieved, reduce the homogenization speed and pressure gradually to avoid air incorporation and ensure uniform texture.

5.4 Post-Homogenization Checks

1. After homogenization, conduct a viscosity test to ensure that the cream has the required texture and consistency, as outlined in the MFR.
2. Test the cream for uniformity by performing a visual inspection. The final product should be smooth, uniform, and free from visible separation or grittiness.
3. If required, perform particle size analysis to confirm that the cream meets the specified particle size criteria. This can be done using a laser diffraction method or similar appropriate testing technique.
4. Check the pH of the homogenized cream to ensure it remains within the desired range, typically between 4.5 and 6.5.

5.5 Cooling the Homogenized Cream

1. After homogenization, cool the cream to room temperature while continuously mixing. The cooling process should be gradual to avoid destabilizing the emulsion.
2. Monitor the temperature of the cream during cooling to ensure it does not exceed the recommended limits for active ingredient stability.
3. Ensure that the cream remains uniform and that no separation occurs during the cooling process.

5.6 Quality Control Testing

1. Once the cream has cooled to room temperature, perform the following quality control tests to ensure product consistency and compliance with specifications:
   • Viscosity: Measure the viscosity to ensure that the cream has the desired consistency.
   • pH: Test the pH to confirm that it falls within the specified range (4.5-6.5).
   • Particle Size: Perform a particle size distribution test to ensure uniformity and stability.
   • Microbial Testing: Conduct microbial testing to verify that the cream is free from contaminants.
2. If the cream passes all quality control tests, it is approved for the next stage of production. If any issues are detected, corrective actions must be taken, and the batch should be reprocessed as needed.

5.7 Documentation and Reporting

1. Document all homogenization parameters, including the pressure, speed, temperature, and time of homogenization, as well as any adjustments made during the process.
2. Record the results of the quality control tests, including viscosity, pH, particle size, and microbial testing, in the batch record.
3. The batch record and test reports must be submitted to the QA department for review and approval before proceeding with packaging or further processing.

5.8 Final Approval and Use of Homogenized Cream

1. Once the homogenized cream passes all quality control tests and is approved by QA, it is ready for further processing (e.g., addition of active ingredients or packaging).
2. Ensure that all documentation is properly filed and retained for future reference and regulatory compliance.

6. Abbreviations

• QC: Quality Control
• QA: Quality Assurance
• GMP: Good Manufacturing Practices
• API: Active Pharmaceutical Ingredient
• MFR: Master Formula Record

7. Documents

1. Homogenization Log (Annexure-1)
2. Batch Record (Annexure-2)
3. Quality Control Test Report (Annexure-3)

8. References

• Good Manufacturing Practices (GMP) Guidelines – 21 CFR Part 211
• International Conference on Harmonisation (ICH) Q7 – Good Manufacturing Practice for Active Pharmaceutical Ingredients
• FDA Guidelines for Cosmetic Manufacturing

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Homogenization Log

Batch Number	Pressure	Speed	Time	Temperature	Remarks
12345	3000 psi	3500 rpm	10 min	55°C	Homogenized successfully

Annexure-2: Batch Record

Batch Number	Process Step	Time	Operator
12345	Homogenization	09:00 AM	John Doe

Annexure-3: Quality Control Test Report

Test Parameter	Result	Specification	Remarks
Viscosity	3200 cP	3000-3500 cP	Pass

Revision History:

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
01/03/2024	1.0	Initial Version	New SOP Creation	QA Head
01/03/2025	2.0	Format Revision and Updates	Standardization of Document	QA Head