Standard Operating Procedure for Use of Stabilizers in Gels Production
1) Purpose
The purpose of this SOP is to outline procedures for selecting, handling, and incorporating stabilizers in gel formulations to ensure product stability and consistency.
2) Scope
This SOP applies to all personnel involved in the production of gels using stabilizers within the pharmaceutical manufacturing facility.
3) Responsibilities
Formulation Scientists: Select appropriate stabilizers and provide guidance on their use.
Production Operators: Handle and incorporate stabilizers according to this SOP.
Quality Control (QC) Analysts: Test the stability and quality of gels containing stabilizers.
Quality Assurance (QA) Team: Review and approve procedures and results related to the use of stabilizers.
4) Procedure
4.1 Selection of Stabilizers
4.1.1 Choose stabilizers based on desired properties such as compatibility with active ingredients, pH, and overall formulation stability.
4.1.2 Ensure selected stabilizers comply with regulatory requirements and product specifications.
4.2 Handling of Stabilizers
4.2.1 Store stabilizers according to manufacturer’s recommendations to maintain their efficacy.
4.2.2 Use appropriate personal protective equipment (PPE) when handling stabilizers.
4.3 Incorporation of Stabilizers
4.3.1 Accurately weigh the required amount of stabilizer using a calibrated balance.
4.3.2 Dissolve or disperse the stabilizer
4.3.3 Ensure thorough mixing to achieve a uniform distribution of the stabilizer within the gel.
4.4 Quality Control Testing
4.4.1 Conduct stability testing to ensure the gel maintains its properties over the intended shelf life.
4.4.2 Perform tests such as pH measurement, viscosity, and visual inspection for phase separation or precipitation.
4.5 Documentation
4.5.1 Record batch numbers, quantities, and lot numbers of stabilizers 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
– ICH Q8(R2): Pharmaceutical Development
– USP General Chapter <1094> Stability Testing of Drug Substances and Drug Products
– Company-specific guidelines on the use of stabilizers
8) SOP Version
Version 1.0