Purpose

The purpose of this SOP is to outline the procedures for conducting density testing during the liquid oral manufacturing process to ensure the proper formulation and quality of the product.

Scope

This SOP applies to all personnel involved in liquid oral manufacturing, specifically those responsible for density testing.

Responsibilities

• Quality Control Analysts: Conducting density testing according to this SOP.
• Production Department: Providing samples for testing and cooperating with quality control personnel.
• Quality Assurance Department: Ensuring compliance with regulatory standards and guidelines.

Procedure

1. Calibrate the density meter using standard calibration solutions.
2. Take the liquid oral sample and ensure it is at the specified temperature.
3. Fill the density meter with the sample and record the density reading.
4. Repeat the process for each sample as per the testing plan.
5. Compare the density values against acceptance criteria.
6. Document all testing procedures, observations, and results accurately and comprehensively.
7. Review and approve the test results by authorized personnel.
8. Initiate corrective actions if deviations from acceptance criteria are identified.

Abbreviations Used

SOP: Standard Operating Procedure
QC: Quality Control
QA: Quality Assurance

Documents

• Density Testing Protocol
• Standard Operating Procedures Manual
• Batch Records
• Quality Control Reports
• Deviation Reports

Reference

No specific references are cited for this SOP.

SOP Version

Version 1.0