Procedure for Taste Testing in Oral Liquids
1) Purpose
The purpose of this SOP is to outline the procedure for testing the taste of oral liquid pharmaceutical products to ensure compliance with specifications and regulatory requirements.
2) Scope
This SOP applies to all oral liquid pharmaceutical products requiring taste testing as part of quality control measures to assess sensory attributes and patient acceptability.
3) Responsibilities
Quality Control (QC) Department: Responsible for performing taste testing.
Quality Assurance (QA) Department: Responsible for review and approval of taste testing procedures and results.
Manufacturing Department: Responsible for providing oral liquid samples and support during testing.
4) Procedure
4.1 Sample Preparation:
4.1.1 Shake the oral liquid sample gently to ensure homogeneity.
4.1.2 Transfer a small amount of sample into a clean, disposable tasting vessel.
4.2 Taste Assessment:
4.2.1 Rinse the mouth with water between samples to avoid cross-contamination.
4.2.2 Take a small sip of the sample and swirl it around the mouth to assess taste.
4.2.3 Evaluate taste characteristics such as sweetness, bitterness, sourness, and any off-notes.
4.3 Data Recording:
4.3.1 Record the results of taste assessment, including qualitative description and any specific observations.
4.3.2 Document any deviations from expected taste characteristics or specifications.
4.4 Reproducibility Testing:
4.4.1 Repeat taste
4.4.2 Ensure agreement in sensory evaluation across multiple assessments.
4.5 Data Analysis:
4.5.1 Compile and review taste testing data, including descriptive assessments and any deviations noted.
4.5.2 Analyze data against acceptance criteria and specifications.
4.6 Reporting:
4.6.1 Prepare a Taste Testing Report summarizing test procedures, results, and conclusions.
4.6.2 Include any corrective actions or recommendations based on taste assessment 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
Taste Testing Report
Sample Testing Data
7) Reference, if any
USP (insert appropriate reference for taste testing)
FDA Guidance for Industry – Container Closure Systems for Packaging Human Drugs and Biologics
8) SOP Version
Version 1.0