Procedure for Color and Clarity Testing in Oral Liquids
1) Purpose
The purpose of this SOP is to outline the procedure for testing the color and clarity 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 color and clarity testing as part of quality control measures to assess visual appearance and quality.
3) Responsibilities
Quality Control (QC) Department: Responsible for performing color and clarity testing.
Quality Assurance (QA) Department: Responsible for review and approval of color and clarity testing procedures and results.
Manufacturing Department: Responsible for providing oral liquid samples and support during testing.
4) Procedure
4.1 Equipment Preparation:
4.1.1 Ensure the colorimeter or visual inspection equipment is calibrated according to manufacturer’s instructions.
4.1.2 Prepare a white background for color assessment if using visual inspection.
4.2 Sample Preparation:
4.2.1 Mix the oral liquid sample thoroughly to ensure homogeneity.
4.2.2 Transfer a sufficient amount of sample into a clean, transparent container.
4.3 Color Testing:
4.3.1 If using a colorimeter, place the sample in the colorimeter and record the color reading.
4.3.2 If using visual inspection, place the sample against the white background and observe color characteristics.
4.3.3 Compare visual assessment with standard color charts or specifications.
4.4 Clarity Testing:
4.4.1 Inspect the sample for visible particles, haze, or turbidity.
4.4.2 If necessary, perform additional tests such as light transmission or visual clarity assessments.
4.4.3 Record observations regarding clarity and any deviations from expected appearance.
4.5 Data Recording:
4.5.1 Record the results of color and clarity testing for each sample.
4.5.2 Document any discrepancies or deviations observed during testing.
4.6 Reproducibility Testing:
4.6.1 Repeat color and clarity assessments on the same sample to confirm reproducibility.
4.6.2 Ensure consistency in results across multiple assessments.
4.7 Data Analysis:
4.7.1 Compile and review color and clarity testing data, including initial readings, visual assessments, and any additional tests conducted.
4.7.2 Analyze data against acceptance criteria and specifications.
4.8 Reporting:
4.8.1 Prepare a Color and Clarity Testing Report summarizing test procedures, results, and conclusions.
4.8.2 Include any corrective actions or recommendations based on color and clarity measurement findings.
4.8.3 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
Color and Clarity Testing Report
Calibration Records
Sample Testing Data
7) Reference, if any
USP (insert appropriate reference for color and clarity testing)
FDA Guidance for Industry – Container Closure Systems for Packaging Human Drugs and Biologics
8) SOP Version
Version 1.0