Purpose

The purpose of this SOP is to outline the procedures for determining moisture content during the tablet manufacturing process to ensure product quality, stability, and compliance with regulatory requirements.

Scope

This SOP applies to all personnel involved in the tablet manufacturing process, particularly those responsible for moisture content determination.

Responsibilities

• Quality Control Analysts: Responsible for conducting moisture content determination 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. Collect representative samples of tablets from the manufacturing process.
2. Weigh and record the initial weight of the samples.
3. Dry the samples using a suitable method such as oven drying or Karl Fischer titration.
4. Weigh the dried samples and calculate the moisture content using the appropriate formula.
5. Compare the moisture content results with established acceptance criteria.
6. Document all testing procedures, observations, and results accurately and comprehensively.
7. Review and approve the test results by authorized personnel.
8. Take corrective actions if deviations from acceptance criteria are identified.

Abbreviations Used

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

Documents

• Moisture Content Determination 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