Standard Operating Procedure for Texture and Spreadability Testing of Creams

Department	Creams
SOP No.	SOP/CRM/035/2025
Supersedes	SOP/CRM/035/2022
Page No.	Page 1 of 5
Issue Date	19/08/2025
Effective Date	24/08/2025
Review Date	19/08/2026

1. Purpose

The purpose of this Standard Operating Procedure (SOP) is to outline the process for testing the texture and spreadability of cream formulations. These properties are crucial in determining the sensory attributes of the product, ensuring that it is easy to apply and provides a pleasant user experience.

2. Scope

This SOP applies to all cream formulations developed within the Creams Department. It covers the procedures for testing the texture and spreadability of the cream, which directly impacts its usability, consumer appeal, and performance.

3. Responsibilities

• Formulation Development Team: Responsible for developing cream formulations that meet the desired texture and spreadability characteristics. They should provide clear guidelines for testing these properties.
• Quality Control (QC): Responsible for performing texture and spreadability tests using the appropriate testing equipment and methods. They should ensure that the results are documented accurately.
• Quality Assurance (QA): Ensures that the texture and spreadability testing procedures are carried out in compliance with GMP standards and that the results are within the required specifications.
• Production Team: Implements the testing procedure during production and provides input on any observed issues regarding the texture or spreadability of the cream during manufacturing.

4. Accountability

The Head of Creams Manufacturing is responsible for overseeing the texture and spreadability testing process. The QA Manager is accountable for ensuring that all tests are conducted in accordance with this SOP, and that results are properly documented and reviewed.

5. Procedure

5.1 Preparation for Texture and Spreadability Testing

1. Prior to testing, ensure that the cream formulation has been properly mixed and that all ingredients are fully incorporated. The sample should be representative of the final product batch.
2. Ensure that the testing equipment, such as texture analyzers, spatulas, and other measurement devices, are clean and calibrated according to the manufacturer’s guidelines.
3. If the cream is being tested for different batches or different formulation variations, ensure that each sample is appropriately labeled and documented.

5.2 Testing Texture of the Cream

1. Texture testing is done to evaluate the consistency, firmness, and spreadability of the cream. The following tests are commonly used:
   • Penetrometer Test: This test measures the firmness of the cream by inserting a probe into the sample at a constant rate and measuring the depth of penetration.
   • Shear Force Test: This test evaluates the cream’s resistance to deformation when pressure is applied. It provides data on the cream’s texture and overall spreadability.
   • Viscosity Test: Although primarily used to assess the thickness of the cream, viscosity testing also provides insight into the cream’s texture by measuring its resistance to flow.
2. Perform the texture test according to the equipment’s instructions. For the penetrometer test, set the probe’s rate of penetration and record the depth of penetration. For the shear force test, apply pressure and measure the force required to deform the cream.
3. Record the test results in the batch record. The results should reflect the desired consistency, firmness, and overall texture of the cream. Ensure that any deviations are documented and addressed.

5.3 Spreadability Testing

1. Spreadability testing measures how easily the cream spreads on the skin and how quickly it is absorbed. The following method is commonly used:
   • Spatula Test: Apply a specified amount of cream to a flat surface and use a spatula to spread it across the surface. Measure the area covered and record the time it takes to spread the cream evenly.
   • Application Test: Apply the cream to the forearm or another area of the body and assess how easily the cream spreads, how it feels during application, and how it absorbs into the skin.
2. Conduct the spreadability test using a standardized procedure. Apply the cream evenly to the surface or skin, and assess the ease of spreading, uniformity, and the amount of resistance experienced during application.
3. Record the spreadability results, including any observations about the cream’s texture or behavior during the application. Document the results in the batch record.

5.4 Data Analysis and Interpretation

1. After conducting the texture and spreadability tests, analyze the data to ensure the cream formulation meets the desired specifications. If the results fall outside the acceptable range, investigate the formulation for potential adjustments.
2. Compare the results from different batches or variations of the formulation to identify any inconsistencies in texture or spreadability. Any issues should be addressed by adjusting the formulation or production process.

5.5 Documentation and Reporting

1. Document all testing activities, including:
   • The method of testing used (e.g., penetrometer, shear force, spatula test)
   • The equipment used and settings (e.g., penetration depth, force applied)
   • The results of the testing (e.g., spreadability measurements, texture values)
   • Any adjustments made to the formulation based on testing results
2. Prepare a Texture and Spreadability Test Report (Annexure-1) summarizing the testing methods, results, and any corrective actions taken.
3. Submit the report for review and approval by the QA team before proceeding to the next stage of product development.

5.6 Final Approval and Commercial Production

1. Once the texture and spreadability have been successfully optimized and meet the required standards, the formulation is approved for commercial production.
2. Ensure that the texture and spreadability tests are repeated as necessary during the production process to maintain consistency across batches.
3. Store all testing data and documentation for future reference and regulatory compliance.

6. Abbreviations

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

7. Documents

1. Texture and Spreadability Test Report (Annexure-1)
2. Formulation Development Log (Annexure-2)
3. Batch Record (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 Testing

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Texture and Spreadability Test Report

Batch Number	Test Method	Test Results	Observations
12345	Penetrometer	4.5 mm penetration	Pass, suitable consistency

Annexure-2: Formulation Development Log

Formulation Name	Batch Number	Ingredients	Process Parameters
Moisturizing Cream	67890	Water, Glycerin, Hyaluronic Acid	Mixing: 30 min, Temperature: 65°C

Annexure-3: Batch Record

Batch Number	Test Date	Texture Results	Spreadability Results
12345	20/08/2025	Pass (Penetration: 4.5 mm)	Pass (Smooth application)

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