The QA Manager is responsible for verifying compliance with this SOP and ensuring product quality.

5. Procedure

5.1 Pre-Mixing and Blending Preparation

1. Ensure that the mixing vessel is clean and free of contaminants.
2. Verify that the ingredients are weighed and ready for mixing, ensuring that all solid and liquid components are at the correct temperatures for mixing.
3. Ensure that the mixing equipment, such as mixers and paddles, is in good condition and calibrated to avoid excessive air incorporation.

5.2 Mixing Process

1. Begin the mixing process at low speed to gently combine ingredients without causing air entrapment.
2. Gradually increase the speed only as necessary to ensure even distribution of the ingredients while maintaining control over air incorporation.
3. Use equipment such as high-shear mixers or mixers with controlled speed settings to limit the introduction of air into the mixture.
4. Ensure that mixing is done in a sealed environment or with minimal exposure to open air to prevent air from being trapped in the cream.

5.3 Monitoring and Control

1. Monitor the mixture regularly for signs of air entrainment, such as foaming or bubbling. If these signs appear, reduce the speed or stop mixing to allow the air to escape.
2. Use a vacuum or deaeration process if necessary to remove any air that has been incorporated into the product.
3. Ensure that the final product has the desired smoothness and uniformity with no visible air pockets or bubbles.

5.4 Post-Mixing Checks

1. Once the mixing is complete, perform a sensory test to check for smoothness and texture consistency. The cream should be free from lumps and air pockets.
2. If air is detected in the final product, adjust the mixing technique, reduce the mixing speed, or use a vacuum process to remove the excess air.
3. Document all batch details, including the mixing time, speed, temperature, and any deviations in the Mixing Log (Annexure-1).

5.5 Documentation and Record Keeping

1. Complete all necessary documentation, including the batch number, mixing parameters, and air entrapment control measures used during the mixing process.
2. Ensure that all records are signed by the operator and reviewed by the QA team to confirm compliance with the SOP and GMP standards.

5.6 Final Approval

1. The QA team must review all records, including batch number, mixing parameters, and air entrapment checks, to verify that the product is compliant with quality standards before it moves to the next stage of manufacturing.
2. If any issues with air entrainment are detected, corrective actions must be taken, and the batch should be reprocessed if necessary.

6. Abbreviations

• GMP: Good Manufacturing Practices
• QC: Quality Control
• QA: Quality Assurance
• PPE: Personal Protective Equipment

7. Documents

1. Annexure-1: Mixing Log
2. Annexure-2: Air Entrapment Control Log

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 Cosmetics 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: Mixing Log

Batch Number	Mixing Time	Mixing Speed	Air Entrainment Check	Operator	Comments
12345	30 minutes	200 RPM	None	John Doe	No issues

Annexure-2: Air Entrapment Control Log

Batch Number	Air Detection (Yes/No)	Method Used for Air Removal	Time	Operator	Comments
12345	No	Standard Mixing	10:00 AM	Jane Smith	No issues

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