Creams: SOP for Feasibility Studies in Cream Development – V 2.0

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Creams: SOP for Feasibility Studies in Cream Development – V 2.0

Standard Operating Procedure for Feasibility Studies in Cream Development

Department Creams
SOP No. SOP/CRM/022/2025
Supersedes SOP/CRM/022/2022
Page No. Page 1 of 5
Issue Date 15/06/2025
Effective Date 20/06/2025
Review Date 15/06/2026

1. Purpose

The purpose of this Standard Operating Procedure (SOP) is to provide guidelines for conducting feasibility studies during the development of new cream formulations. Feasibility studies are crucial for evaluating the potential success of a formulation before large-scale production, considering factors such as ingredient compatibility, product performance, cost-effectiveness, and regulatory compliance.

2. Scope

This SOP applies to all feasibility studies conducted during the development of new cream formulations within the Creams Department. It covers the process of initial formulation evaluation, ingredient compatibility testing, performance assessments, and any preliminary regulatory review before advancing to scale-up and commercialization.

3. Responsibilities

  • Formulation Development Team: Responsible for conducting the feasibility study, including selecting appropriate ingredients, testing for compatibility, and assessing performance characteristics.
  • Quality Control (QC): Responsible for assisting with testing procedures, conducting stability and performance evaluations, and ensuring that the cream formulations meet established standards.
  • Quality Assurance (QA): Responsible for ensuring that the feasibility study adheres to regulatory and GMP requirements and reviewing all documentation to ensure accuracy and compliance.
  • Regulatory Affairs: Responsible for reviewing the feasibility study to ensure that the formulation will meet regulatory requirements in the target markets.

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4. Accountability

The Head of Creams Manufacturing is responsible for ensuring that feasibility studies are conducted properly. The QA Manager is accountable for overseeing the proper documentation, regulatory compliance, and ensuring that all steps in the feasibility study are completed as per the SOP.

5. Procedure

5.1 Selection of Ingredients and Formulation Design

  1. Begin by reviewing the intended product’s objectives (e.g., moisturizing, therapeutic, or anti-aging) to select appropriate active ingredients (APIs), excipients, preservatives, and other components.
  2. Choose ingredients based on compatibility, stability, and desired performance in the final product. Ensure that ingredients comply with safety and regulatory standards.
  3. Develop an initial formulation, specifying the concentrations and ratios of each ingredient to create a working sample for testing.
  4. Consider the target market (e.g., sensitive skin formulations or hypoallergenic products) and any specific requirements that may influence ingredient selection.

5.2 Ingredient Compatibility Testing

  1. Conduct tests to determine if selected ingredients are compatible with each other. This includes checking for any adverse interactions between active ingredients, excipients, and preservatives.
  2. Perform preliminary tests on ingredient mixtures to check for issues such as separation, phase instability, or changes in texture or color.
  3. If any ingredient incompatibilities are detected, reformulate the mixture by substituting or adjusting ingredient concentrations to achieve the desired results.

5.3 Performance Evaluation

  1. Prepare small laboratory batches of the cream formulation and test them for key performance characteristics such as:

    • Viscosity
    • Spreadability
    • Absorption rate
    • Appearance and texture
    • Stability under various conditions (e.g., temperature, light exposure)
  2. Conduct sensory evaluation to assess the product’s feel, scent, and overall sensory characteristics. This may involve small panel testing for consumer preferences.
  3. If necessary, adjust the formulation based on performance test results to meet the desired product attributes.
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5.4 Stability Testing

  1. Submit the formulation for initial stability testing under both accelerated and real-time conditions. Testing should include:

    • Storage stability (e.g., temperature, humidity)
    • Microbial stability (if applicable)
    • Physical stability (e.g., viscosity changes, separation)
  2. Adjust the formulation as necessary based on the stability testing results to ensure long-term stability without degradation or separation.

5.5 Cost and Manufacturing Feasibility

  1. Evaluate the cost-effectiveness of the formulation by assessing the cost of ingredients, packaging, and production processes.
  2. Collaborate with the production team to ensure that the formulation can be scaled up efficiently, and that production processes are feasible within the company’s manufacturing capabilities.
  3. If any ingredients are prohibitively expensive or difficult to source, consider alternative options that meet performance and cost requirements.

5.6 Regulatory Review

  1. Work with the regulatory affairs team to ensure that the formulation complies with local and international regulatory standards.
  2. Review the formulation and any associated claims for safety, efficacy, and marketing approval based on the regulatory guidelines in the target market.
  3. Submit the feasibility study findings and formulation details to the relevant regulatory bodies for approval before advancing to large-scale production.

5.7 Final Review and Decision

  1. The formulation, after undergoing all necessary testing and evaluations, should be reviewed by the development team and QA to ensure it meets all requirements.
  2. Once the formulation passes all feasibility assessments, a decision is made to either move forward to pilot-scale batch development or to discontinue the formulation development.
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6. Abbreviations

  • QC: Quality Control
  • QA: Quality Assurance
  • API: Active Pharmaceutical Ingredient
  • GMP: Good Manufacturing Practices
  • ICH: International Conference on Harmonisation

7. Documents

  1. Feasibility Study Report (Annexure-1)
  2. Stability Test Report (Annexure-2)
  3. Formulation Development 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
  • Internal SOP for Stability Testing and Product Development

9. SOP Version

Version: 2.0

10. Approval Section

Prepared By Checked By Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Feasibility Study Report

Formulation Name Batch Number Ingredients Process Summary Feasibility Outcome
Moisturizing Cream 12345 Water, Glycerin, Aloe Vera Mixing, Heating, Homogenization Feasible for development

Annexure-2: Stability Test Report

Test Type Test Result Test Date Approval Status
Accelerated Stability Pass 10/06/2025 Approved

Annexure-3: Formulation Development Log

Formulation Name Batch Number Ingredients Process Description Feasibility Study Outcome
Anti-Aging Cream 67890 Retinol, Glycerin, Aloe Vera Mixing, Homogenization, pH Adjustment Feasible for large-scale production

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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