and that the end-point is correctly detected. The QA Manager is responsible for reviewing and ensuring the process complies with regulatory and quality standards.

5. Procedure

5.1 Pre-Mixing Preparation

1. Ensure that all ingredients for the cream formulation are pre-weighed, prepared, and ready for mixing.
2. Verify that the mixing vessel is clean and properly prepared for use.
3. Check that all mixing equipment (e.g., mixers, paddles, and sensors) are calibrated and functioning correctly.

5.2 Mixing Process

1. Transfer the ingredients into the mixing vessel in the correct order, following the formulation’s requirements.
2. Start the mixing process at a low speed to combine the ingredients and gradually increase the speed as the mixture becomes more uniform.
3. Ensure that the mixing process is controlled to prevent the incorporation of air and achieve the desired consistency.

5.3 End-Point Detection

1. During the mixing process, monitor key indicators for the end-point, including viscosity, consistency, and texture.
2. Use a rheometer or viscometer to measure the cream’s viscosity. The end-point is reached when the viscosity readings stabilize within the required range.
3. Alternatively, perform sensory checks by testing the texture and spreadability of the cream. The end-point is confirmed when the cream is smooth, with no lumps, and exhibits the correct consistency.
4. Perform a sample test by taking a small quantity of the mixture and allowing it to cool to check for uniformity in texture.

5.4 Post Mixing Checks

1. Once the end-point is detected, stop the mixing process to prevent over-processing or degradation of the product.
2. Conduct a visual and tactile inspection of the cream to ensure it meets the required consistency and texture standards.
3. Document the end-point detection results in the Mixing Log (Annexure-1), noting the time, temperature, and readings taken during the process.

5.5 Documentation

1. Complete all relevant documentation, including batch numbers, mixing parameters (time, speed, temperature), and end-point test results in the Mixing Log (Annexure-1).
2. Ensure that all records are reviewed and signed by the operator and the QA team to confirm compliance with the SOP.

5.6 Final Approval

1. The QA team must review the mixing and end-point detection records and confirm that the cream batch has met the quality specifications before it moves to the next phase (e.g., transfer to storage or packaging).
2. If the cream batch does not meet the required end-point characteristics, the process should be flagged for corrective action.

6. Abbreviations

• GMP: Good Manufacturing Practices
• QC: Quality Control
• QA: Quality Assurance
• PPE: Personal Protective Equipment
• R&D: Research and Development

7. Documents

1. Annexure-1: Mixing Log
2. Annexure-2: Sensory Testing Log
3. Annexure-3: End-Point Detection Report

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	End-Point Detected (Yes/No)	Operator	Comments
12345	30 minutes	200 RPM	Yes	John Doe	No issues

Annexure-2: Sensory Testing Log

Batch Number	Texture	Spreadability	Color	Fragrance	Test Result
12345	Smooth	Good	White	Lavender	Pass

Annexure-3: End-Point Detection Report

Batch Number	End-Point Detected (Yes/No)	Final Viscosity	Final Texture	Operator	Comments
12345	Yes	1000 cP	Smooth	Jane Smith	End-point achieved successfully

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