SOP Guide for Pharma

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

Auditor

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

Standard Operating Procedure for Manufacturing Thermosensitive Gels in Gel Manufacturing

Department Gel Manufacturing
SOP No. SOP/GM/194/2025
Supersedes SOP/GM/194/2022
Page No. Page 1 of 12
Issue Date 10/06/2025
Effective Date 12/06/2025
Review Date 10/06/2027

1. Purpose

To outline the procedure for manufacturing thermosensitive gels that undergo sol-gel transformation in response to body or ambient temperature, ensuring product quality, consistency, and compliance.

2. Scope

This SOP is applicable to all thermosensitive gel formulations processed in the Gel Manufacturing Department of the pharmaceutical facility.

3. Responsibilities

  • Formulation Scientist: Responsible for selection of thermosensitive polymers and formulation design.
  • Production Chemist: Executes batch processing under controlled conditions.
  • Quality Assurance (QA): Monitors compliance and reviews batch records.

4. Accountability

Head – Manufacturing is accountable for ensuring compliance with this SOP.

See also  Gel Manufacturing: SOP for Monitoring Homogenization Efficiency - V 2.0

5. Procedure

5.1 Raw Material and Equipment

Preparation
  1. Verify availability of key ingredients such as Pluronic F127, Pluronic F68, or other approved thermoresponsive polymers.
  2. Ensure all materials are approved and released by QA.
  3. Calibrate temperature probes and ensure vessels are cleaned as per SOP/GM/073/2025.

5.2 Gel Compounding Process

  1. Dissolve polymer base in cold purified water (2–8°C) using a mechanical stirrer.
  2. Maintain continuous agitation while gradually increasing polymer concentration for required gelation temperature.
  3. Incorporate drug substance at low temperature to prevent degradation.
  4. pH and viscosity should be monitored and adjusted accordingly using buffer agents.

5.3 Sol-Gel Transition Verification

  1. Transfer small quantity of gel to test vials and gradually heat to 37°C to assess sol-gel transition.
  2. Document gelation point and confirm against the specification in Annexure-3.

5.4 Filling and Sealing

  1. Filter final product through sterile mesh where applicable.
  2. Fill into pre-cooled containers to preserve sol state at the time of filling.
  3. Seal and label containers with batch details.

5.5 In-process Controls and QC Testing

  • Appearance, sol-gel transition temperature, viscosity at room and body temperature, drug content, pH, and microbial limits.
  • Perform in-vitro release studies at different temperatures to assess temperature sensitivity.

5.6 Documentation

  1. Fill out batch manufacturing record and record all temperatures and times accurately.
  2. Attach cleaning logs, calibration logs, and deviation reports if any.

6. Abbreviations

  • QA: Quality Assurance
  • QC: Quality Control
  • BMR: Batch Manufacturing Record
  • SOP: Standard Operating Procedure

7. Documents

  1. Batch Manufacturing Record – Annexure-1
  2. Thermosensitive Gel Formulation Sheet – Annexure-2
  3. Sol-Gel Transition Test Report – Annexure-3
  4. In-Process Control Checklist – Annexure-4
  5. Filling and Sealing Log – Annexure-5

8. References

  • ICH Q8: Pharmaceutical Development
  • ICH Q6A: Specifications
  • Schedule M – GMP Guidelines

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

Batch No. Product Name Date Formulator QA Reviewer

Annexure-2: Thermosensitive Gel Formulation Sheet

Polymer Concentration (%) Gelation Temp (°C) Appearance Checked By

Annexure-3: Sol-Gel Transition Test Report

Sample ID Temp (°C) State Observed Time to Gelation (sec) QC Signature
37

Annexure-4: In-Process Control Checklist

Parameter Specification Observed Value Done By Date
pH 5.5–7.0
Viscosity 10,000–30,000 cps

Annexure-5: Filling and Sealing Log

Date Machine ID Operator Start Time End Time Remarks

Revision History

Revision Date Revision No. Change Description Reason Approved By
01/06/2022 1.0 Initial version New SOP QA Manager
10/06/2025 2.0 Added Annexure-3 for transition testing Process improvement QA Head
Exit mobile version