Procedure for Grittiness Testing in Topical Preparations
1) Purpose
The purpose of this SOP is to outline the procedure for testing grittiness in topical preparations to ensure product quality and patient satisfaction.
2) Scope
This SOP applies to all topical preparations requiring grittiness testing as part of quality control measures to assess sensory properties and formulation uniformity.
3) Responsibilities
Quality Control (QC) Department: Responsible for performing grittiness testing.
Quality Assurance (QA) Department: Responsible for review and approval of grittiness 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 Prepare samples by dispensing a specified amount of topical preparation into clean, dry containers.
4.1.2 Ensure samples are representative of the batch and free from visible particles or contaminants.
4.2 Test Setup:
4.2.1 Apply the topical preparation onto the skin or a suitable surface for sensory evaluation.
4.2.2 Rub the preparation gently between fingers or over the surface to assess for grittiness.
4.3 Sensory Evaluation:
4.3.1 Rate the sensation of grittiness on a predefined scale (e.g., 0-5) by trained evaluators.
4.3.2 Evaluate multiple samples from different areas of the batch to ensure representativeness.
4.4 Data Collection:
4.4.1 Record sensory evaluation scores and any qualitative
4.4.2 Document test conditions, such as room temperature and lighting, to maintain consistency.
4.5 Reproducibility Testing:
4.5.1 Repeat grittiness testing on multiple samples to confirm consistency in sensory evaluations.
4.5.2 Ensure agreement in sensory scores within acceptable tolerance limits.
4.6 Reporting:
4.6.1 Prepare a Grittiness Testing Report summarizing test procedures, results, and conclusions.
4.6.2 Include any recommendations for formulation adjustments based on grittiness testing findings.
4.6.3 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
Grittiness Testing Report
Sample Testing Records
7) Reference, if any
USP (insert appropriate reference for topical preparations)
FDA Guidance for Industry – Skin Irritation and Sensitization Testing of Generic Transdermal Drug Products
8) SOP Version
Version 1.0