Creams: SOP for Manufacturing Aqueous Cream Bases – V 2.0

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Creams: SOP for Manufacturing Aqueous Cream Bases – V 2.0

Standard Operating Procedure for Manufacturing Aqueous Cream Bases

Department Creams
SOP No. SOP/CRM/053/2025
Supersedes SOP/CRM/053/2022
Page No. Page 1 of 6
Issue Date 17/11/2025
Effective Date 22/11/2025
Review Date 17/11/2026

1. Purpose

The purpose of this Standard Operating Procedure (SOP) is to outline the process for manufacturing aqueous cream bases. Aqueous cream bases are essential in cream formulations, serving as the primary vehicle for active ingredients and ensuring the desired texture and stability. This SOP defines the procedures for preparing the aqueous cream base to ensure that the final product meets all quality standards, including consistency, viscosity, and stability.

2. Scope

This SOP applies to the preparation of aqueous cream bases in the Creams Department. It includes procedures for mixing, heating, cooling, and blending the aqueous base components to create a stable foundation for subsequent cream formulations.

3. Responsibilities

  • Production Team: Responsible for following this SOP to prepare the aqueous cream base. They must ensure that all ingredients are accurately measured, mixed, and processed according to the procedure.
  • Quality Control (QC): Responsible for testing the aqueous cream base for consistency, viscosity, pH, and other quality parameters to ensure it meets the specifications defined 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.
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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.
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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.
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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
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