Procedure for Odor Testing in Oral Liquids

1) Purpose

The purpose of this SOP is to outline the procedure for testing the odor 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 odor testing as part of quality control measures to assess sensory attributes and quality.

3) Responsibilities

Quality Control (QC) Department: Responsible for performing odor testing.
Quality Assurance (QA) Department: Responsible for review and approval of odor 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 Allow the oral liquid sample to equilibrate to room temperature if stored under refrigeration.
    4.1.2 Open the sample container and allow the odor to develop.

4.2 Odor Assessment:
    4.2.1 Hold the sample container approximately 2-3 inches from the nose.
    4.2.2 Sniff the sample to assess the odor characteristics.
    4.2.3 Evaluate the odor intensity, description, and any off-notes compared to a standard reference.

4.3 Data Recording:
    4.3.1 Record the results of odor assessment, including qualitative description and any specific observations.
    4.3.2 Document any deviations from expected odor characteristics or specifications.

4.4 Reproducibility Testing:
    4.4.1 Repeat odor assessments by different personnel to confirm consistency.
    4.4.2 Ensure agreement in sensory evaluation across multiple assessments.

4.5 Data Analysis:
    4.5.1 Compile and review odor 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 an Odor Testing Report summarizing test procedures, results, and conclusions.
    4.6.2 Include any corrective actions or recommendations based on odor 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

Odor Testing Report
Sample Testing Data

7) Reference, if any

USP (insert appropriate reference for odor testing)
FDA Guidance for Industry – Container Closure Systems for Packaging Human Drugs and Biologics

8) SOP Version

Version 1.0