Standard Operating Procedure for Oil-in-Water Cream Manufacturing
1) Purpose
The purpose of this SOP is to outline the steps required for the preparation of oil-in-water (O/W) creams in a pharmaceutical manufacturing setting to ensure consistency, quality, and compliance with regulatory standards.
2) Scope
This SOP applies to all personnel involved in the manufacturing of oil-in-water creams within the pharmaceutical production facility. It covers the entire process from raw material preparation to the final product.
3) Responsibilities
The purpose of SOP here
4) Procedure
4.1 Preparation of Equipment and Materials
4.1.1 Ensure that all equipment and utensils are clean, calibrated, and in good working condition.
4.1.2 Verify the availability of all required raw materials and excipients.
4.1.3 Set up the production area according to GMP guidelines.
4.2 Weighing and Mixing of Ingredients
4.2.1 Weigh the oil phase ingredients (e.g., oils, waxes) as per the formulation sheet.
4.2.2 Heat the oil phase ingredients in a jacketed kettle to the specified temperature (e.g., 70-80°C) to melt the waxes and homogenize the mixture.
4.2.3 Weigh the water phase ingredients (e.g., water, glycerin, preservatives) as per the formulation sheet.
4.2.4 Heat the water phase ingredients in a separate vessel to the same temperature as the oil phase.
4.3 Emulsification Process
4.3.1 Gradually add the oil phase to the water phase with continuous stirring using a high-shear mixer.
4.3.2 Continue mixing until a uniform emulsion is formed. Monitor the temperature to ensure it remains consistent.
4.3.3 Cool the emulsion to room temperature while maintaining gentle stirring to prevent separation.
4.4 Homogenization
4.4.1 Transfer the cooled emulsion to a homogenizer.
4.4.2 Homogenize the emulsion at the specified pressure and time to achieve the desired particle size and texture.
4.4.3 Perform in-process checks for consistency and homogeneity of the cream.
4.5 Final Adjustments and Quality Control
4.5.1 Adjust the pH of the cream if necessary, using suitable pH adjusters.
4.5.2 Perform a final quality control check, including tests for pH, viscosity, and microbial load.
4.5.3 Document all observations and results in the batch record.
5) Abbreviations, if any
O/W: Oil-in-Water
GMP: Good Manufacturing Practices
6) Documents, if any
Batch Manufacturing Record (BMR)
Standard Test Methods (STMs) for quality control
7) Reference, if any
ICH Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
FDA Guidance for Industry: Non-Sterile Semisolid Dosage Forms
8) SOP Version
Version 1.0