SOP Guide for Pharma

Gel Manufacturing: SOP for Formulating Alcohol-Based Gels – V 2.0

Auditor

Gel Manufacturing: SOP for Formulating Alcohol-Based Gels – V 2.0

Standard Operating Procedure for Alcohol-Based Gel Formulation in Gel Manufacturing

Department Gel Manufacturing
SOP No. SOP/GM/169/2025
Supersedes SOP/GM/169/2022
Page No. Page 1 of 10
Issue Date 09/06/2025
Effective Date 11/06/2025
Review Date 09/06/2027

1. Purpose

To establish a standardized process for the formulation of alcohol-based gels used in pharmaceutical and personal care applications, ensuring safety, consistency, and efficacy of the product.

2. Scope

This SOP is applicable to formulation scientists and production personnel involved in developing, testing, and manufacturing alcohol-based gels in the Gel Manufacturing Department.

3. Responsibilities

  • Formulation Scientist: Responsible for designing and validating alcohol-based gel formulations.
  • Production Supervisor: Ensures implementation of the formulation procedure on manufacturing scale.
  • QA Personnel: Verifies compliance and approves records and results.

4. Accountability

The Head of Gel Manufacturing and Head of Quality Assurance are jointly accountable for

compliance with this SOP.
See also  Gel Manufacturing: SOP for In-Process Viscosity Testing - V 2.0

5. Procedure

5.1 Selection of Alcohol and Gelling Agents

  1. Use pharmaceutical grade alcohols such as Ethanol (70–95%) or Isopropyl Alcohol (IPA).
  2. Select suitable gelling agents like:
    • Carbomers (Carbopol 940, 980)
    • Hydroxypropylcellulose (HPC)
    • Acrylates/C10–30 Alkyl Acrylate Crosspolymer

5.2 Equipment Preparation

  1. Ensure all vessels and mixing equipment are clean, dry, and calibrated.
  2. Ensure electrical equipment is explosion-proof due to alcohol volatility.

5.3 Formulation Process

  1. In a mixing tank, prepare the aqueous phase by dissolving any water-soluble ingredients (e.g., preservatives, humectants).
  2. Slowly add the gelling agent to water with continuous stirring. Allow proper hydration.
  3. Add neutralizer (e.g., triethanolamine) if using Carbomer, to adjust viscosity.
  4. Once the gel base is ready, slowly incorporate alcohol under continuous stirring, ensuring homogeneity.
  5. Check for any phase separation, air entrapment, or gel syneresis.
See also  Gel Manufacturing: SOP for Operating Sealing Machines for Gel Tubes - V 2.0

5.4 Safety Precautions

  1. Ensure proper ventilation during alcohol handling.
  2. Use flame-proof mixers and ensure grounding of all vessels.
  3. Personnel must wear appropriate PPE (gloves, mask, safety goggles).

5.5 Evaluation and Testing

  1. Check physical parameters: viscosity, pH, clarity, alcohol content, and microbial limit.
  2. Conduct stability testing under ICH conditions for minimum 3 months (accelerated and long-term).

5.6 Documentation

  1. Record all formulation batches in Formulation Record Log – Annexure-1.
  2. Capture evaluation results in Formulation Evaluation Sheet – Annexure-2.
  3. Stability data to be recorded in Stability Summary Sheet – Annexure-3.

6. Abbreviations

  • IPA: Isopropyl Alcohol
  • QA: Quality Assurance
  • ICH: International Council for Harmonisation
  • PPE: Personal Protective Equipment

7. Documents

  1. Formulation Record Log – Annexure-1
  2. Formulation Evaluation Sheet – Annexure-2
  3. Stability Summary Sheet – Annexure-3

8. References

  • ICH Q1A(R2) – Stability Testing of New Drug Substances and Products
  • USP General Chapter <795> – Pharmaceutical Compounding
  • FDA Guidance for Industry – Topical Antiseptic Products
See also  Gel Manufacturing: SOP for Ensuring Uniform Mixing During Gel Production - V 2.0

9. SOP Version

Version: 2.0

10. Approval Section

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

11. Annexures

Annexure-1: Formulation Record Log

Batch No. Alcohol Type Gelling Agent Neutralizer Remarks

Annexure-2: Formulation Evaluation Sheet

Test Method Result Specification Remarks
Viscosity Brookfield Viscometer 20,000–60,000 cps
pH pH Meter 5.5–7.5
Alcohol Content GC 65–80%

Annexure-3: Stability Summary Sheet

Condition Time Point Observations Result
25°C/60% RH 1M/3M/6M
40°C/75% RH 1M/3M/6M

Revision History

Revision Date Revision No. Change Description Reason Approved By
18/03/2022 1.0 Initial Version New SOP QA Manager
09/06/2025 2.0 Format Revision with Annexures Compliance Update QA Manager
Exit mobile version