Creams: SOP for Preparing and Using Pre-Mixes in Cream Production – V 2.0

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Creams: SOP for Preparing and Using Pre-Mixes in Cream Production – V 2.0

Standard Operating Procedure for Preparing and Using Pre-Mixes in Cream Production

Department Creams
SOP No. SOP/CRM/078/2025
Supersedes SOP/CRM/078/2022
Page No. Page 1 of 6
Issue Date 21/01/2026
Effective Date 26/01/2026
Review Date 21/01/2027

1. Purpose

The purpose of this SOP is to outline the process for preparing and using pre-mixes in cream production. Pre-mixes are prepared in advance to ensure consistent quality, improve production efficiency, and reduce mixing times during the manufacturing process.

2. Scope

This SOP applies to the preparation and use of pre-mixes in all cream manufacturing processes within the Creams Department. It covers the preparation of ingredients, storage, and the controlled addition of pre-mixes during production.

3. Responsibilities

  • Production Team: Responsible for following the SOP during the preparation and use of pre-mixes, ensuring that all steps are conducted accurately and efficiently.
  • Quality Control (QC): Ensures the quality of pre-mixes, conducts testing for consistency, and verifies that the pre-mix meets specifications before use in production.
  • Quality Assurance (QA): Oversees the compliance of pre-mix preparation with GMP standards, ensures documentation is completed correctly, and reviews batch records.
  • Maintenance Team: Ensures that all equipment used in pre-mix preparation is calibrated, cleaned, and maintained to prevent contamination or malfunction.

4. Accountability

The Head of Production is accountable for ensuring that the preparation and use of pre-mixes are conducted according to this SOP. The QA Manager is responsible for reviewing and ensuring compliance with quality standards.

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5. Procedure

5.1 Preparation of Pre-Mixes

  1. Ensure all raw materials required for the pre-mix are available and meet quality specifications.
  2. Weigh and measure the raw materials as per the pre-mix formulation. Ensure that the ingredients are free of contaminants and are within the allowable limits for use.
  3. Transfer the ingredients into a clean and dry mixing vessel. Begin the mixing process at low speed to ensure proper dispersion of ingredients.
  4. Gradually increase the speed as needed to achieve a uniform pre-mix. Continue mixing until a smooth, homogeneous mixture is obtained.
  5. Monitor the viscosity, texture, and consistency of the pre-mix to ensure it meets the required specifications. Use instruments like viscometers for precise measurements, if necessary.
  6. Once the pre-mix is ready, document the batch number, ingredient batch numbers, and any adjustments made during preparation in the Pre-Mix Log (Annexure-1).

5.2 Storage of Pre-Mixes

  1. Transfer the prepared pre-mix into clean, sealed containers to prevent contamination. Label the containers with the batch number, preparation date, and required storage conditions (e.g., temperature).
  2. Store the pre-mix in a cool, dry, and controlled environment to maintain its quality until it is used in production.
  3. Ensure that pre-mixes are used within their shelf life. Any pre-mixes that are beyond the recommended storage period must be discarded.
  4. Document the storage conditions and shelf life in the Pre-Mix Storage Log (Annexure-2).
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5.3 Use of Pre-Mixes in Cream Production

  1. Before using the pre-mix, verify that it has been stored correctly and is within its shelf life.
  2. Ensure that the pre-mix is well-mixed and uniform before transferring it to the production vessel.
  3. Add the pre-mix to the cream formulation according to the batch record and process instructions. Follow the proper addition sequence to ensure that the pre-mix blends seamlessly with other ingredients.
  4. Monitor the cream mixture for proper consistency, texture, and homogeneity after the addition of the pre-mix. If necessary, adjust the process to achieve the desired properties.
  5. Document the use of pre-mixes in the Batch Production Record (Annexure-3), including the batch number, quantity used, and any deviations.

5.4 Post-Use Checks and Documentation

  1. After use, verify the consistency and texture of the cream product to ensure that the pre-mix was effectively incorporated into the batch.
  2. Conduct a sensory evaluation of the cream to check for smoothness and uniformity.
  3. Complete the Pre-Mix Use Log (Annexure-3), documenting the batch number, quantities, and any observations made during production.

5.5 Final Approval

  1. The QA team must review the production records, including the pre-mix preparation, storage, and use logs, to ensure compliance with quality and safety standards before the batch proceeds to the next phase of manufacturing or packaging.
  2. If any discrepancies or issues arise during pre-mix preparation or use, corrective actions must be initiated, and the batch must be reprocessed if necessary.
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6. Abbreviations

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

7. Documents

  1. Annexure-1: Pre-Mix Log
  2. Annexure-2: Pre-Mix Storage Log
  3. Annexure-3: Pre-Mix Use Log
  4. Annexure-4: Batch Production Record

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: Pre-Mix Log

Batch Number Ingredient Added Pre-Mix Viscosity Mixing Time Operator Comments
12345 Water, Emulsifiers, Stabilizers 500 cP 20 minutes John Doe No issues

Annexure-2: Pre-Mix Storage Log

Batch Number Storage Condition Shelf Life Storage Date Operator Comments
12345 Cool and Dry 6 months 21/01/2026 Jane Smith Stored under ideal conditions

Annexure-3: Pre-Mix Use Log

Batch Number Quantity Used Production Batch Number Operator Comments
12345 500g 98765 John Doe Pre-mix added as per process

Annexure-4: Batch Production Record

Batch Number Production Date Pre-Mix Used Final Product Volume Operator Comments
98765 21/01/2026 500g 200L Jane Smith Batch produced as per SOP

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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