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.
5. Procedure
5.1 Raw Material and Equipment
Preparation
- Verify availability of key ingredients such as Pluronic F127, Pluronic F68, or other approved thermoresponsive polymers.
- Ensure all materials are approved and released by QA.
- Calibrate temperature probes and ensure vessels are cleaned as per SOP/GM/073/2025.
5.2 Gel Compounding Process
- Dissolve polymer base in cold purified water (2–8°C) using a mechanical stirrer.
- Maintain continuous agitation while gradually increasing polymer concentration for required gelation temperature.
- Incorporate drug substance at low temperature to prevent degradation.
- pH and viscosity should be monitored and adjusted accordingly using buffer agents.
5.3 Sol-Gel Transition Verification
- Transfer small quantity of gel to test vials and gradually heat to 37°C to assess sol-gel transition.
- Document gelation point and confirm against the specification in Annexure-3.
5.4 Filling and Sealing
- Filter final product through sterile mesh where applicable.
- Fill into pre-cooled containers to preserve sol state at the time of filling.
- 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
- Fill out batch manufacturing record and record all temperatures and times accurately.
- 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
- Batch Manufacturing Record – Annexure-1
- Thermosensitive Gel Formulation Sheet – Annexure-2
- Sol-Gel Transition Test Report – Annexure-3
- In-Process Control Checklist – Annexure-4
- 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 |