SOP Guide for Pharma

Gel Manufacturing: SOP for Developing Herbal Gels – V 2.0

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Gel Manufacturing: SOP for Developing Herbal Gels – V 2.0

Standard Operating Procedure for Development of Herbal Gels in Gel Manufacturing

Department Gel Manufacturing
SOP No. SOP/GM/183/2025
Supersedes SOP/GM/183/2022
Page No. Page 1 of 8
Issue Date 09/06/2025
Effective Date 11/06/2025
Review Date 09/06/2027

1. Purpose

To define the standard procedure for developing herbal gels using botanical extracts to ensure consistency, safety, and efficacy of the final product.

2. Scope

This SOP applies to all research and production teams involved in the formulation, preparation, and quality testing of herbal gels in the Gel Manufacturing Department.

3. Responsibilities

  • Formulation Scientist: Select appropriate herbal extracts and carriers.
  • Production Chemist: Follow the approved formulation and batch manufacturing process.
  • Quality Assurance: Ensure adherence to SOP and review records.
  • Quality Control: Perform tests on raw materials and finished products.

4. Accountability

The Head – Manufacturing is accountable

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