Standard Operating Procedure for Adding Fragrance and Colors during Cream Manufacturing

Department	Creams
SOP No.	SOP/CRM/070/2025
Supersedes	SOP/CRM/070/2022
Page No.	Page 1 of 6
Issue Date	21/01/2026
Effective Date	26/01/2026
Review Date	21/01/2027

1. Purpose

This Standard Operating Procedure (SOP) outlines the process for adding fragrance and colors during the manufacturing of cream products. The procedure ensures that fragrances and colorants are added in the correct proportions, maintaining product consistency, stability, and quality. Adherence to this SOP ensures compliance with safety standards, product specifications, and GMP guidelines.

2. Scope

This SOP applies to all batches of cream products in which fragrance and color are incorporated during the manufacturing process in the Creams Department. It covers the process from the preparation, addition, and thorough mixing of fragrances and colorants to ensure uniform distribution throughout the product.

3. Responsibilities

• Production Team: Responsible for adding fragrance and colors to the cream according to the formulation and ensuring the ingredients are added correctly and uniformly.
• Quality Control (QC): Responsible for verifying the batch consistency after adding fragrance and colors, ensuring no defects are introduced in the product’s appearance or odor.
• Quality Assurance (QA): Responsible for ensuring that the addition of fragrance and color complies with GMP standards and product specifications.
• Ingredient Supplier: Responsible for providing fragrances and colorants that meet safety, regulatory, and quality standards, including batch-specific Certificate of Analysis (CoA).

4. Accountability

The Head of Production is accountable for ensuring that this SOP is followed during the addition of fragrance and colors. The QA Manager is responsible for reviewing and approving the product batches after the fragrance and color are added.

5. Procedure

5.1 Pre-Addition Preparation

1. Ensure that all required fragrances and colors are available, pre-weighed, and ready for addition. Verify that the ingredients are compatible with the cream formulation.
2. Inspect the quality of the fragrance and colorants to confirm that they meet the required specifications. Check the Certificates of Analysis (CoA) for each batch.
3. Ensure the mixing area is clean and free of contamination. Prepare the necessary tools and equipment, such as mixing vessels and spatulas.
4. Verify the formulation and batch records to ensure that the correct fragrance and color are being used in the correct proportions.

5.2 Adding Fragrance and Colors

1. Once the cream formulation has reached the required consistency and all base ingredients have been thoroughly mixed, add the pre-weighed fragrance and colorant slowly to the batch.
2. Ensure that the fragrance and color are added in stages to prevent clumping and ensure even distribution throughout the cream. Stir gently to incorporate the ingredients.
3. Monitor the consistency of the cream during the addition of fragrance and color. If the mixture becomes too thick or uneven, adjust the mixing speed accordingly.
4. After adding the ingredients, continue mixing the cream for the required time to ensure uniform dispersion of the fragrance and color.

5.3 Post-Addition Checks

1. Inspect the cream for uniform color and fragrance. Ensure there are no visible streaks or uneven patches. If necessary, adjust the mixing time or speed to achieve a uniform result.
2. Perform sensory testing on the product, including odor and texture. Ensure that the fragrance is well-balanced and not overpowering.
3. Record the batch number, quantities of fragrance and color used, and any other relevant data in the Mixing Log (Annexure-1).
4. If the batch fails the uniformity or sensory test, report the deviation to the QA team for investigation and corrective actions.

5.4 Quality Control Testing

1. The QC team will conduct quality control tests on the final cream batch to ensure that the fragrance and color are properly incorporated. Testing may include color consistency, fragrance intensity, and overall product appearance.
2. The QC team will ensure that all specifications for fragrance, color intensity, and appearance are met before approval for further processing.
3. Document all test results in the Quality Control Test Log (Annexure-2).

5.5 Documentation

1. Complete all documentation related to the addition of fragrance and color, including batch number, quantities used, and test results.
2. Ensure that all records are signed by the operator and reviewed by QA for compliance with the required standards.

5.6 Final Approval

1. The QA team must review all documentation and test results before approving the batch for release or transfer to packaging.
2. If any deviations are observed during testing or inspection, the batch should be flagged for review and appropriate corrective actions taken.

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: Quality Control Test 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	Fragrance Added	Color Added	Mixing Time	Operator	Comments
12345	Lavender	Pink	45 minutes	John Doe	No issues

Annexure-2: Quality Control Test Log

Batch Number	Color Consistency	Fragrance Intensity	Appearance	Operator	Test Results
12345	Uniform	Moderate	Good	Jane Smith	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