in the Master Formula Record (MFR).

Quality Assurance (QA): Ensures that the manufacturing process is compliant with this SOP and that all records are complete and accurate. QA is also responsible for approving the final aqueous cream base before it proceeds to the next stage of production.

Maintenance Team: Responsible for ensuring that all equipment used during the preparation of the aqueous cream base is cleaned, calibrated, and functioning properly before use.

4. Accountability

The Head of Creams Manufacturing is responsible for ensuring that the preparation of the aqueous cream base follows the procedure outlined in this SOP. The QA Manager is accountable for ensuring that the base meets the required specifications and that proper documentation is completed.

5. Procedure

5.1 Preparation of Ingredients

1. Gather all ingredients required for the aqueous cream base as outlined in the MFR. This typically includes water, emulsifiers, stabilizers, and preservatives.
2. Ensure that all ingredients are within their expiration dates and are free from contamination.
3. Measure each ingredient accurately according to the proportions specified in the MFR.
4. Ensure that the mixing vessels, utensils, and equipment are clean and ready for use.

5.2 Mixing the Aqueous Base

1. Heat the water phase ingredients (e.g., water, hydrophilic emulsifiers) to the specified temperature (typically between 70°C – 80°C) in a suitable heating vessel. Ensure that the temperature is monitored and maintained within the specified range.
2. In a separate vessel, prepare the oil phase ingredients (e.g., oils, lipophilic emulsifiers) and heat them to the required temperature (typically between 70°C – 80°C).
3. Slowly add the oil phase to the water phase while stirring continuously using a high-shear mixer or homogenizer to form an emulsion.
4. Continue mixing until a uniform, smooth emulsion is achieved. The emulsion should be homogeneous without any visible separation.
5. Monitor the temperature of the emulsion during mixing to ensure it does not exceed the specified limits.

5.3 Cooling the Aqueous Cream Base

1. Once the emulsion has formed, begin cooling the mixture while maintaining gentle agitation to prevent the separation of phases.
2. Cool the cream base to room temperature (approximately 20°C – 25°C), depending on the formulation requirements, ensuring that it remains uniform and stable throughout the cooling process.
3. During the cooling phase, ensure that the cream base is properly monitored for consistency, viscosity, and texture.

5.4 Addition of Active Ingredients and Preservatives

1. Once the aqueous cream base has cooled to the required temperature, begin adding active ingredients, preservatives, and any other additives as per the MFR.
2. Add each ingredient slowly, ensuring that it is completely dissolved or dispersed before adding the next ingredient.
3. Mix thoroughly using appropriate equipment to ensure that all ingredients are fully incorporated and the cream base maintains its uniformity.

5.5 Testing the Aqueous Cream Base

1. After mixing, the QC team should test the cream base for key parameters, including:
   • Viscosity
   • pH
   • Appearance (e.g., uniformity, color)
   • Stability (e.g., phase separation)
2. If the cream base passes all tests, it is approved for further use in the next phase of the cream manufacturing process. If any tests fail, the formulation may need to be adjusted, or the batch may need to be discarded, depending on the nature of the deviation.

5.6 Documentation and Record-Keeping

1. Document all steps of the manufacturing process, including the ingredient batch numbers, quantities used, processing times, and temperatures, in the batch record.
2. Ensure that all test results, including viscosity, pH, and appearance, are documented and filed in the batch record for traceability and quality control purposes.
3. If any deviations occur during manufacturing, document the actions taken and the results of any reprocessing or adjustments.

5.7 Final Approval and Use of Aqueous Cream Base

1. Once the aqueous cream base meets all specifications, it is approved for use in the next stage of cream production, such as adding additional active ingredients or proceeding to the filling stage.
2. Ensure that the cream base is properly labeled and stored in appropriate containers if it is not immediately used.

6. Abbreviations

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

7. Documents

1. Batch Record (Annexure-1)
2. Viscosity Test Report (Annexure-2)
3. pH 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 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: Batch Record

Batch Number	Ingredient	Quantity Used	Processing Time	Temperature
12345	Water	500 L	30 min	75°C

Annexure-2: Viscosity Test Report

Batch Number	Viscosity	Specification	Remarks
12345	1500 cP	1000 – 2000 cP	Pass

Annexure-3: pH Test Report

Batch Number	pH	Specification	Remarks
12345	5.2	4.5 – 6.5	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