Standard Operating Procedure for Use of Gelling Agents in Gels Production

1) Purpose

The purpose of this SOP is to define the procedures for selecting, handling, and incorporating gelling agents in gel formulations to ensure consistent product quality and performance.

2) Scope

This SOP applies to all personnel involved in the production of gels using gelling agents within the pharmaceutical manufacturing facility.

3) Responsibilities

Formulation Scientists: Select appropriate gelling agents and provide guidance on their use.
Production Operators: Handle and incorporate gelling agents according to this SOP.
Quality Control (QC) Analysts: Test the consistency and quality of gels containing gelling agents.
Quality Assurance (QA) Team: Review and approve procedures and results related to the use of gelling agents.

4) Procedure

4.1 Selection of Gelling Agents
4.1.1 Choose gelling agents based on desired properties such as viscosity, stability, and compatibility with active ingredients.
4.1.2 Ensure selected gelling agents comply with regulatory requirements and product specifications.

4.2 Handling of Gelling Agents
4.2.1 Store gelling agents in a cool, dry place according to manufacturer’s recommendations.
4.2.2 Use appropriate personal protective equipment (PPE) when handling gelling agents.

4.3 Incorporation of Gelling Agents
4.3.1 Weigh the required amount of gelling agent accurately using a calibrated balance.
4.3.2 Gradually add the gelling agent to the aqueous phase of the formulation while stirring continuously to prevent clumping.
4.3.3 Continue stirring until the gelling agent is fully hydrated and dispersed.

4.4 Quality Control Testing
4.4.1 Test the viscosity and homogeneity of the gel to ensure proper incorporation of the gelling agent.
4.4.2 Conduct stability testing to verify that the gel maintains its properties over time.

4.5 Documentation
4.5.1 Record batch numbers, quantities, and lot numbers of gelling agents used in production.
4.5.2 Maintain records of QC tests and stability studies.

5) Abbreviations, if any

SOP: Standard Operating Procedure
PPE: Personal Protective Equipment
QC: Quality Control
QA: Quality Assurance

6) Documents, if any

– Batch Production Records
– QC Testing Records
– Stability Testing Reports

7) Reference, if any

– USP General Chapter <911> Viscosity
– ICH Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
– Company-specific guidelines on the use of gelling agents

8) SOP Version

Version 1.0