for the implementation and compliance with this SOP and for ensuring that all gel formulations meet applicable standards.

5. Procedure

5.1 Selection of Herbal Actives

1. Select herbal ingredients based on therapeutic activity (e.g., aloe vera for soothing, neem for antimicrobial).
2. Ensure the herbal raw materials meet pharmacopeial or in-house specifications.

5.2 Herbal Extract Procurement and Verification

1. Procure standardised extracts (aqueous, ethanolic, hydroalcoholic) from approved vendors.
2. Verify certificate of analysis (CoA) and perform in-house identification tests (e.g., TLC, HPLC).

5.3 Gel Base Preparation

1. Prepare gel base using natural or synthetic polymers such as Carbopol®, xanthan gum, or guar gum.
2. Dissolve the polymer in purified water under slow stirring until fully hydrated.
3. Adjust pH using citric acid, sodium hydroxide, or TEA to attain gel consistency (typically pH 5.0–6.5).

5.4 Incorporation of Herbal Extracts

1. Weigh and slowly incorporate herbal extracts into the gel base to avoid lump formation.
2. Mix thoroughly using an overhead stirrer or homogenizer until a uniform blend is achieved.
3. Minimize air entrapment by performing final mixing under vacuum where applicable.

5.5 Addition of Preservatives and Additives

1. Add natural or approved preservatives such as potassium sorbate, sodium benzoate, or phenoxyethanol.
2. Include optional additives such as essential oils, vitamins, or humectants depending on the formulation goals.

5.6 In-Process and Final Quality Checks

1. Check organoleptic properties (color, odor, consistency).
2. Measure pH, viscosity, and microbial limits.
3. Test for active content uniformity and stability in accelerated conditions.

5.7 Packaging and Storage

1. Fill into collapsible tubes, jars, or pump bottles under hygienic conditions.
2. Label appropriately with herbal content declaration, expiry date, and storage conditions.
3. Store finished product in controlled room temperature (20–25°C), away from direct light.

6. Abbreviations

• SOP: Standard Operating Procedure
• QA: Quality Assurance
• QC: Quality Control
• HPLC: High Performance Liquid Chromatography
• TLC: Thin Layer Chromatography
• CoA: Certificate of Analysis

7. Documents

1. Approved Herbal Gel Formulation Sheet – Annexure-1
2. Herbal Extract Quality Control Report – Annexure-2
3. Batch Manufacturing Record – Annexure-3
4. Stability Study Protocol – Annexure-4
5. Finished Product Specification Sheet – Annexure-5

8. References

• WHO Guidelines on Good Agricultural and Collection Practices (GACP) for Medicinal Plants
• ICH Q6A – Specifications: Test Procedures and Acceptance Criteria
• Ayurvedic Pharmacopoeia of India

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation	Formulation Scientist	QA Executive	Head – Manufacturing
Department	Gel Manufacturing	Quality Assurance	Manufacturing

11. Annexures

Annexure-1: Approved Herbal Gel Formulation Sheet

Herbal Ingredient	Quantity (%)	Function

Annexure-2: Herbal Extract Quality Control Report

Test	Specification	Result	Approved By

Annexure-3: Batch Manufacturing Record

Step	Observation	Performed By	Date

Annexure-4: Stability Study Protocol

Condition	Duration	Parameters to Monitor
25°C / 60% RH	3 Months	Appearance, pH, Viscosity
40°C / 75% RH	6 Months	Microbial Load, Active Content

Annexure-5: Finished Product Specification Sheet

Parameter	Specification	Result
pH	5.0–6.5
Appearance	Green, smooth gel
Viscosity	25,000–50,000 cps

Revision History

Revision Date	Revision No.	Description of Change	Reason	Approved By
15/02/2022	1.0	Initial release of SOP	New herbal gel development	QA Head
09/06/2025	2.0	Updated to include natural preservative guidelines	Regulatory Compliance	QA Head