Gel Manufacturing: SOP for Production of Thermosensitive Gels – V 2.0

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Gel Manufacturing: SOP for Production of Thermosensitive Gels – V 2.0

Standard Operating Procedure for Production of Thermosensitive Gels in Gel Manufacturing

Department Gel Manufacturing
SOP No. SOP/GM/191/2025
Supersedes SOP/GM/191/2022
Page No. Page 1 of 11
Issue Date 09/06/2025
Effective Date 11/06/2025
Review Date 09/06/2027

1. Purpose

To define the procedure for manufacturing thermosensitive gel formulations, including material handling, solubilization, gelation temperature calibration, and quality control to ensure functional and regulatory compliance.

2. Scope

This SOP applies to all thermosensitive gel products manufactured in the Gel Manufacturing department of the pharmaceutical facility.

3. Responsibilities

  • Production Officer: Execute batch manufacturing operations per batch manufacturing record (BMR).
  • QC Analyst: Perform temperature calibration and viscosity measurements at different temperatures.
  • QA Executive: Verify process adherence and record review for batch release.

4. Accountability

The Head of Gel Manufacturing shall be accountable for implementing and

monitoring this SOP and ensuring compliance with GMP standards.

See also  Gel Manufacturing: SOP for Mixing and Homogenization of Gel Formulations - V 2.0

5. Procedure

5.1 Material Preparation

  1. Receive and verify all excipients and APIs listed in the BMR.
  2. Weigh materials in accordance with SOP for material dispensing in cleanroom conditions.

5.2 Solubilization and Mixing

  1. Use cold or room-temperature purified water for initial dispersion of thermosensitive polymers (e.g., Poloxamers, Pluronics).
  2. Mix under controlled low-shear conditions using a stainless steel stirrer or magnetic stirrer.
  3. Incorporate other excipients such as preservatives, APIs, or enhancers as per formulation requirements.

5.3 Thermo-Gelling Behavior Calibration

  1. Transfer small aliquots of the batch into sample vials.
  2. Heat samples gradually from 10°C to 50°C and observe sol-gel transition point.
  3. Document the gelation temperature range for the formulation.
  4. Ensure the final formulation remains liquid at room temperature and gels at physiological temperature (~37°C).

5.4 Final Homogenization

  1. Perform final homogenization using a high-shear mixer at 2000–3000 rpm for 10–15 minutes.
  2. Maintain process temperature below the gelation point during mixing.
See also  Gel Manufacturing: SOP for Process Validation of Gel Manufacturing - V 2.0

5.5 Filtration and Filling

  1. Filter the gel using 0.45 µm or 0.22 µm membrane filter under laminar airflow.
  2. Fill into appropriate primary packaging (e.g., collapsible tubes, bottles) using peristaltic or piston fillers at controlled temperature.

5.6 In-process and Final Testing

  • Appearance, pH, viscosity at 25°C and 37°C, gelation temperature, microbial limits, and assay of API.

5.7 Documentation

  • Complete all entries in BMR and attach analytical reports before batch release.

6. Abbreviations

  • API: Active Pharmaceutical Ingredient
  • BMR: Batch Manufacturing Record
  • GMP: Good Manufacturing Practice
  • QA: Quality Assurance
  • QC: Quality Control

7. Documents

  1. Batch Manufacturing Record – Annexure-1
  2. Gelation Temperature Log – Annexure-2
  3. Viscosity Test Report – Annexure-3
  4. In-process Testing Checklist – Annexure-4

8. References

  • ICH Q8(R2) – Pharmaceutical Development
  • ICH Q9 – Quality Risk Management
  • WHO TRS 961 – Annex 3: GMP Guidelines
See also  Gel Manufacturing: SOP for Verification of Cleaning Effectiveness of Gel Equipment - V 2.0

9. SOP Version

Version: 2.0

10. Approval Section

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

11. Annexures

Annexure-1: Batch Manufacturing Record Template

Product Name
Batch No.
Manufacturing Date
Expiry Date
Manufacturing Steps
Critical Parameters
Operator Name/Signature

Annexure-2: Gelation Temperature Log

Sample No. Temp (°C) State Gelation Observed (Y/N) Remarks

Annexure-3: Viscosity Test Report

Sample ID Temp (°C) Viscosity (cP) Instrument Used Operator

Annexure-4: In-process Testing Checklist

Parameter Specification Test Result Complies (Y/N) Tested By
Appearance
pH
Viscosity
Gelation Temp

Revision History

Revision Date Revision No. Change Description Reason Approved By
18/03/2022 1.0 Initial issue New SOP QA Head
09/06/2025 2.0 Included updated annexures and WHO references Periodic review QA Head
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