SOP for Preparation of Water-in-Oil Creams

SOP for Preparation of Water-in-Oil Creams

Standard Operating Procedure for Water-in-Oil Cream Manufacturing

1) Purpose

The purpose of this SOP is to outline the steps required for the preparation of water-in-oil (W/O) 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 water-in-oil 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.

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4.1.3 Set up the production area according to GMP guidelines.

4.2 Weighing and Mixing of Ingredients

4.2.1 Weigh the water phase ingredients (e.g., water, glycerin, preservatives) as per the formulation sheet.

4.2.2 Heat the water phase ingredients in a vessel to the specified temperature (e.g., 70-80°C).

4.2.3 Weigh the oil phase ingredients (e.g., oils, waxes, emulsifiers) as per the formulation sheet.

4.2.4 Heat the oil phase ingredients in a jacketed kettle to the same temperature as the water phase to melt the waxes and homogenize the mixture.

4.3 Emulsification Process

4.3.1 Gradually add the water phase to the oil phase with continuous stirring using a high-shear mixer.

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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.

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5) Abbreviations, if any

W/O: Water-in-Oil

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

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