Procedure for Specific Gravity Testing in Oral Liquids
1) Purpose
The purpose of this SOP is to outline the procedure for testing the specific gravity 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 specific gravity testing as part of quality control measures to assess density and consistency.
3) Responsibilities
Quality Control (QC) Department: Responsible for performing specific gravity testing.
Quality Assurance (QA) Department: Responsible for review and approval of specific gravity 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 Calibrate the specific gravity meter according to manufacturer’s instructions.
4.1.2 Ensure the sample container is clean and dry.
4.2 Sample Preparation:
4.2.1 Allow the oral liquid sample to equilibrate to room temperature if stored under refrigeration.
4.2.2 Transfer a sufficient amount of sample into the sample container.
4.3 Specific Gravity Measurement:
4.3.1 Immerse the specific gravity meter probe into the oral liquid sample, ensuring it is fully submerged.
4.3.2 Allow the meter reading to stabilize as per manufacturer’s instructions, then record the specific gravity value.
4.4 Calibration Verification:
4.4.1 Verify specific gravity meter calibration periodically using standard reference materials.
4.4.2 Adjust specific gravity meter if readings deviate from expected values.
4.5 Data Recording:
4.5.1 Record the specific gravity value obtained from each sample tested.
4.5.2 Document any observations or deviations from expected results.
4.6 Reproducibility Testing:
4.6.1 Repeat specific gravity measurements on the same sample to confirm reproducibility.
4.6.2 Compare results and ensure consistency within acceptable limits.
4.7 Data Analysis:
4.7.1 Compile and review specific gravity measurement data, including initial readings, calibration checks, and reproducibility testing results.
4.7.2 Analyze data against acceptance criteria and specifications.
4.8 Reporting:
4.8.1 Prepare a Specific Gravity Testing Report summarizing test procedures, results, and conclusions.
4.8.2 Include any corrective actions or recommendations based on specific gravity 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
Specific Gravity Testing Report
Calibration Records
Sample Testing Data
7) Reference, if any
USP (insert appropriate reference for specific gravity testing)
FDA Guidance for Industry – Container Closure Systems for Packaging Human Drugs and Biologics
8) SOP Version
Version 1.0