SOP Guide for Pharma

Gel Manufacturing: SOP for Development of Cosmetic Gels – V 2.0

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Gel Manufacturing: SOP for Development of Cosmetic Gels – V 2.0

Standard Operating Procedure for Developing Cosmetic Gels in Gel Manufacturing

Department Gel Manufacturing
SOP No. SOP/GM/170/2025
Supersedes SOP/GM/170/2022
Page No. Page 1 of 10
Issue Date 09/06/2025
Effective Date 11/06/2025
Review Date 09/06/2027

1. Purpose

To define the step-by-step procedure for the development of cosmetic gels, ensuring safety, quality, aesthetic appeal, and compliance with cosmetic product regulations.

2. Scope

This SOP applies to formulation development personnel and quality teams involved in the research, testing, and manufacturing of cosmetic gel formulations within the Gel Manufacturing department.

3. Responsibilities

  • Formulation Scientist: Responsible for designing cosmetic gel formulas and ensuring product safety and efficacy.
  • Quality Assurance (QA): Verifies the product’s compliance with cosmetic standards and maintains documentation.
  • Regulatory Affairs: Ensures compliance with local and global cosmetic regulations.
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4. Accountability

The Head of Gel Manufacturing and

the Head of Regulatory Affairs are accountable for ensuring proper implementation of this SOP.

5. Procedure

5.1 Initial Formulation Design

  1. Determine the type of cosmetic gel to be developed (e.g., moisturizing, anti-aging, brightening, sunscreen).
  2. Select active ingredients (e.g., aloe vera, hyaluronic acid, niacinamide) based on target claims.
  3. Select suitable gelling agents like Carbopol, Xanthan gum, or Guar gum for desired texture and viscosity.
  4. Define the sensory attributes (e.g., clarity, spreadability, fragrance) desired in the final product.

5.2 Ingredient Compatibility and Stability

  1. Conduct pre-formulation studies to check compatibility among actives, excipients, and preservatives.
  2. Prepare small trial batches and evaluate for homogeneity, appearance, and separation under ambient conditions.

5.3 Sample Preparation

  1. Weigh all ingredients accurately as per formulation sheet.
  2. Dissolve water-soluble components in the aqueous phase.
  3. Hydrate the gelling agent in water with continuous stirring, adjusting pH if required.
  4. Add oil-soluble components in a separate oil phase and emulsify if needed.
  5. Combine the two phases under controlled mixing to obtain uniform gel.
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5.4 Evaluation and Testing

  1. Check viscosity using a viscometer and adjust as required.
  2. Determine pH and modify if needed to match skin compatibility (4.5 to 6.5).
  3. Conduct stability studies at 25°C, 40°C, and 4°C for minimum 3 months.
  4. Perform microbial testing, preservative efficacy test (PET), and patch testing.

5.5 Documentation

  1. Record all batch manufacturing details in the Cosmetic Gel Development Log – Annexure-1.
  2. Document test results in Evaluation Data Sheet – Annexure-2.
  3. Compile a development summary in Final Formulation Report – Annexure-3.

6. Abbreviations

  • PET: Preservative Efficacy Test
  • QA: Quality Assurance
  • SOP: Standard Operating Procedure

7. Documents

  1. Cosmetic Gel Development Log – Annexure-1
  2. Evaluation Data Sheet – Annexure-2
  3. Final Formulation Report – Annexure-3
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8. References

  • ISO 22716: Cosmetics — Good Manufacturing Practices (GMP)
  • BIS IS 4707 (Part 1 and Part 2) – List of cosmetic ingredients
  • FDA CFR Title 21 Part 700 – Cosmetic Products

9. SOP Version

Version: 2.0

10. Approval Section

Prepared By Checked By Approved By
Signature
Date
Name
Designation R&D Executive QA Executive Head – Manufacturing
Department Gel Manufacturing Quality Assurance Manufacturing

11. Annexures

Annexure-1: Cosmetic Gel Development Log

Batch No. Date Formulation Code Remarks

Annexure-2: Evaluation Data Sheet

Parameter Method Result Specification
Viscosity Brookfield 20,000–80,000 cps
pH pH Meter 4.5–6.5
Clarity Visual Clear/Opaque

Annexure-3: Final Formulation Report

Formulation Code Approved Date Test Summary Conclusion

Revision History

Revision Date Revision No. Change Description Reason Approved By
10/03/2022 1.0 Initial Issue New SOP QA Manager
09/06/2025 2.0 Revised with new annexures Regulatory Alignment QA Manager
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