Standard Operating Procedure for Developing Perfume Stability in Creams

Department	Creams
SOP No.	SOP/CRM/031/2025
Supersedes	SOP/CRM/031/2022
Page No.	Page 1 of 6
Issue Date	30/07/2025
Effective Date	04/08/2025
Review Date	30/07/2026

1. Purpose

The purpose of this Standard Operating Procedure (SOP) is to establish the process for developing and evaluating perfume stability in cream formulations. Perfume stability ensures that the fragrance in the cream remains consistent, effective, and safe for use throughout the product’s shelf life, without degrading or reacting with other ingredients.

2. Scope

This SOP applies to all cream formulations that contain added perfumes or fragrances. It covers the process of selecting, developing, and testing fragrance stability to ensure that the final product meets customer expectations in terms of scent, safety, and shelf life.

3. Responsibilities

• Formulation Development Team: Responsible for selecting the fragrance components and incorporating them into the cream formulation. They must ensure that the fragrance is compatible with the formulation.
• Quality Control (QC): Responsible for performing stability tests to evaluate the fragrance stability under various conditions and ensuring that the fragrance remains consistent throughout the product’s shelf life.
• Quality Assurance (QA): Oversees the perfume stability testing process, ensuring compliance with internal standards, regulatory guidelines, and the final approval of the product’s stability profile.
• Regulatory Affairs: Ensures that the fragrance used in the product complies with all relevant regulatory requirements, including safety standards for use in topical cosmetic products.

4. Accountability

The Head of Creams Manufacturing is responsible for overseeing the development of perfume stability in cream formulations. The QA Manager is accountable for ensuring that fragrance stability testing is conducted in compliance with regulatory and internal standards.

5. Procedure

5.1 Selection of Fragrance Components

1. Select the fragrance components based on the product’s intended use, target market, and desired sensory characteristics (e.g., floral, citrus, etc.).
2. Ensure that the selected fragrance is compatible with the cream formulation and will not interfere with the cream’s texture, color, or stability.
3. Obtain safety and regulatory documentation for the selected fragrance ingredients, including safety data sheets (SDS) and compliance with relevant fragrance regulations.

5.2 Incorporating Fragrance into the Cream Formulation

1. Add the fragrance to the cream formulation in the appropriate concentration, following formulation specifications. The concentration should be based on both desired sensory characteristics and regulatory guidelines.
2. Blend the fragrance thoroughly into the cream formulation to ensure uniform distribution. Use appropriate mixing techniques to avoid any fragrance instability or degradation during the mixing process.

5.3 Perfume Stability Testing

1. Conduct stability tests to evaluate how the fragrance holds up over time. The testing should include:
   • Real-Time Stability Testing: Store samples of the cream formulation with fragrance under normal storage conditions and monitor the fragrance over time.
   • Accelerated Stability Testing: Expose samples to extreme conditions such as high temperatures or light to simulate prolonged storage and observe any changes in the fragrance.
   • Oxidative Stability: Assess the fragrance’s resistance to oxidation, which can cause the scent to degrade or change.
2. Test fragrance stability at various stages of the product’s shelf life (e.g., 1 month, 3 months, 6 months) to determine any loss of fragrance strength or alteration in scent.
3. Record any observations regarding changes in the fragrance, including fading, alteration of scent, or the development of off-odors.

5.4 Analytical Testing of Fragrance Stability

1. Conduct analytical tests to assess any chemical changes in the fragrance components over time. These tests may include:
   • Gas Chromatography (GC): Used to analyze the composition of fragrance components and detect any degradation products.
   • Headspace Analysis: Measures volatile components of the fragrance to determine any evaporation or loss of fragrance over time.
   • Color and pH Testing: Ensures that the fragrance has not caused any unwanted color changes or alterations in the cream’s pH.
2. Compare the test results from the fragrance stability studies to the initial test results to evaluate any significant changes in the composition or sensory properties.

5.5 Documentation of Perfume Stability Results

1. Document all stability testing results, including:
   • The testing conditions (e.g., temperature, light exposure)
   • The initial and final fragrance characteristics
   • Test results from analytical methods (e.g., GC, headspace analysis)
   • Any deviations or changes observed during stability testing
2. Prepare a Perfume Stability Report (Annexure-1) that includes all findings and conclusions. The report should clearly state whether the fragrance remains stable throughout the product’s shelf life and whether it meets the product’s quality standards.
3. Submit the Perfume Stability Report for review and approval by the QA team before proceeding to commercialization.

5.6 Final Approval and Commercialization

1. Once the perfume stability tests are completed and the results are satisfactory, finalize the product formulation for commercial production.
2. Ensure that all regulatory submissions related to the fragrance are completed and that the fragrance complies with all safety and regulatory standards for cosmetic products.
3. Document the final formulation and all related stability testing in the product development files.

6. Abbreviations

• QC: Quality Control
• QA: Quality Assurance
• GMP: Good Manufacturing Practices
• API: Active Pharmaceutical Ingredient
• GC: Gas Chromatography

7. Documents

1. Perfume Stability Report (Annexure-1)
2. Formulation Development Log (Annexure-2)
3. Stability Testing Log (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 Cosmetic Product Safety

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Perfume Stability Report

Test Type	Initial Fragrance	Final Fragrance	Test Date	Result
Real-time Stability	Floral	Floral (No Change)	25/07/2025	Pass

Annexure-2: Formulation Development Log

Formulation Name	Batch Number	Ingredients	Fragrance	Fragrance Test Results
Moisturizing Cream	67890	Water, Glycerin, Hyaluronic Acid	Rose	Pass (Stability over 6 months)

Annexure-3: Stability Testing Log

Test Type	Test Date	Fragrance Observations	Approval Status
Oxidative Stability	12/07/2025	No degradation or off-odors	Approved

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