Standard Operating Procedure for Organogel Preparation
1) Purpose
The purpose of this SOP is to provide a detailed and standardized procedure for the preparation of organogel in the pharmaceutical industry, ensuring product consistency, quality, and regulatory compliance.
2) Scope
This SOP applies to all personnel involved in the preparation and manufacturing of organogel within the pharmaceutical production facility.
3) Responsibilities
Production Manager: Ensure the organogel preparation process is executed according to this SOP.
Production Staff: Follow the detailed steps outlined in this SOP for organogel preparation.
Quality Control (QC) Personnel: Conduct necessary quality checks to ensure the organogel meets specified standards.
4) Procedure
4.1 Preparation and Setup
4.1.1 Verify that all equipment and the work area are clean and sanitized according to the relevant cleaning SOP.
4.1.2 Gather and confirm the quality and quantity of all raw materials as per the batch record.
4.2 Mixing Process
4.2.1 Pour the required amount of oil phase (e.g., mineral oil) into the mixing vessel.
4.2.2 Add the gelling agent (e.g., sorbitan monostearate) to the oil phase under continuous stirring to prevent clumping.
4.2.3 Heat the mixture to the specified temperature to dissolve the gelling agent completely.
4.3 Heating and Homogenization
4.3.1 Maintain the mixture at the specified temperature for the required duration, ensuring complete dissolution.
4.3.2 Homogenize the mixture using a high-shear mixer for the specified time to achieve a uniform gel consistency.
4.4 Cooling and Additives Incorporation
4.4.1 Gradually cool the mixture to room temperature under controlled conditions.
4.4.2 Add active ingredients, preservatives, or other additives as per the formulation requirements.
4.4.3 Mix thoroughly to ensure uniform distribution of all components.
4.5 Quality Control Testing
4.5.1 Take samples of the organogel and perform quality control tests as specified in the QC SOP.
4.5.2 Confirm that the organogel meets all predefined quality parameters before moving to the packaging stage.
4.6 Packaging and Labeling
4.6.1 Transfer the organogel to the packaging area in accordance with the packaging SOP.
4.6.2 Package the organogel in appropriate containers and label them according to the labeling SOP.
5) Abbreviations, if any
SOP: Standard Operating Procedure
QC: Quality Control
6) Documents, if any
– Batch Manufacturing Record
– Raw Material Specifications
– Cleaning Records
– Quality Control Test Results
7) Reference, if any
– FDA Guidance for Industry: Manufacture of Non-Sterile Drug Products
– ICH Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
8) SOP Version
Version 1.0