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.

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

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