Procedure for Spreadability Testing in Topical Preparations
1) Purpose
The purpose of this SOP is to outline the procedure for testing spreadability in topical preparations to ensure ease of application and consistency.
2) Scope
This SOP applies to all topical preparations requiring spreadability testing as part of quality control measures to assess product performance and user experience.
3) Responsibilities
Quality Control (QC) Department: Responsible for performing spreadability testing.
Quality Assurance (QA) Department: Responsible for review and approval of spreadability testing procedures and results.
Manufacturing Department: Responsible for providing topical preparation samples and support during testing.
4) Procedure
4.1 Sample Preparation:
4.1.1 Ensure topical preparation samples are well-mixed and at the appropriate temperature for testing.
4.1.2 Use samples that are representative of the batch and free from visible defects.
4.2 Test Setup:
4.2.1 Place a specified amount of the topical preparation onto a standardized surface (e.g., glass plate).
4.2.2 Use a specified weight or pressure to spread the preparation uniformly over the surface.
4.3 Spreadability Measurement:
4.3.1 Measure the diameter of the spread preparation after a specified time interval or number of strokes.
4.3.2 Calculate the spreadability index using the appropriate formula (e.g., diameter spread/weight applied).
4.4 Reproducibility Testing:
4.4.1 Repeat spreadability testing on multiple samples
4.4.2 Ensure agreement in spreadability index measurements within acceptable tolerance limits.
4.5 Cleaning and Maintenance:
4.5.1 Clean the glass plate or surface and any equipment used for testing between measurements.
4.5.2 Store equipment properly after use as per manufacturer instructions.
4.6 Data Recording:
4.6.1 Record spreadability index values, test conditions, and any deviations observed during testing.
4.6.2 Document all spreadability measurement results accurately in the appropriate records.
4.7 Reporting:
4.7.1 Prepare a Spreadability Testing Report summarizing test procedures, results, and conclusions.
4.7.2 Include any corrective actions or recommendations based on spreadability testing findings.
4.7.3 Submit the report to QA for review and approval and maintain records as per facility procedures.
5) Abbreviations, if any
QC: Quality Control
QA: Quality Assurance
6) Documents, if any
Spreadability Testing Report
Sample Testing Records
7) Reference, if any
USP (insert appropriate reference for topical preparations)
FDA Guidance for Industry – Container Closure Systems for Packaging Human Drugs and Biologics
8) SOP Version
Version 1.0