Standard Operating Procedure for Use of Stabilizers in Creams Production
1) Purpose
The purpose of this SOP is to define the procedures for the selection and incorporation of stabilizers in creams production to ensure product stability and quality.
2) Scope
This SOP applies to all personnel involved in the formulation, manufacturing, and quality control of creams, including formulation scientists, production operators, and quality assurance (QA) personnel. It covers the procedures for stabilizer selection, addition, and documentation.
3) Responsibilities
It is the responsibility of formulation scientists to select appropriate stabilizers based on formulation requirements, production operators to accurately weigh and incorporate stabilizers into the formulation, and QA personnel to verify compliance with specifications.
4) Procedure
4.1 Selection of Stabilizers
4.1.1 Refer to the formulation development report or master formula to identify the recommended stabilizers and their concentration ranges.
4.1.2 Evaluate the compatibility of stabilizers with other formulation components (e.g., emulsifiers, active ingredients).
4.1.3 Choose stabilizers based on their functionality (e.g., viscosity control, emulsion stability) and compatibility with the cream formulation.
4.2 Preparation for Stabilizer Addition
4.2.1 Review the batch record and formulation worksheet to determine the amount of stabilizer required for the batch.
4.2.2 Ensure all equipment (e.g., scales, mixing vessels) is clean, calibrated, and suitable for handling
4.2.3 Wear appropriate personal protective equipment (PPE) such as gloves and lab coat during stabilizer handling to prevent skin contact and inhalation.
4.3 Addition of Stabilizers
4.3.1 Weigh the specified amount of stabilizer accurately using a calibrated scale.
4.3.2 Add the stabilizer to the cream formulation according to the formulation instructions, ensuring uniform dispersion.
4.3.3 Use gentle mixing or stirring to incorporate the stabilizer into the formulation without introducing air bubbles.
4.4 Mixing and Homogenization
4.4.1 Homogenize or mix the cream formulation thoroughly to ensure even distribution of the stabilizer throughout the batch.
4.4.2 Control mixing parameters (e.g., speed, duration) to achieve a homogeneous cream with consistent stability and texture.
4.5 Quality Control
4.5.1 Perform viscosity testing to assess the effectiveness of stabilizers in controlling cream viscosity.
4.5.2 Conduct stability testing (e.g., centrifugation, freeze-thaw cycles) to evaluate the robustness of the cream formulation.
4.5.3 Monitor pH levels to ensure the cream formulation remains within specified stability limits.
4.6 Documentation and Review
4.6.1 Document all details of stabilizer selection, addition, and processing in the batch record or formulation worksheet.
4.6.2 Review the stabilizer addition procedure and quality control results to ensure compliance with formulation specifications.
4.6.3 Submit the batch documentation for review and approval by QA personnel before further processing or packaging.
5) Abbreviations, if any
QA: Quality Assurance
PPE: Personal Protective Equipment
SOP: Standard Operating Procedure
6) Documents, if any
Formulation Development Report
Master Formula Record
Batch Record
Formulation Worksheet
7) Reference, if any
ICH Q1A(R2): Stability Testing of New Drug Substances and Products
USP (United States Pharmacopeia) General Chapter on Stability of Pharmaceutical Products
8) SOP Version
Version 1.0