Purpose

The purpose of this SOP is to outline the procedures for conducting disintegration testing during the tablet manufacturing process to ensure proper breakdown and dissolution of tablets.

Scope

This SOP applies to all personnel involved in tablet manufacturing, specifically those responsible for disintegration testing.

Responsibilities

• Quality Control Analysts: Conducting disintegration 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. Prepare disintegration testing apparatus according to manufacturer instructions.
2. Place a tablet in each of the testing tubes or baskets of the apparatus.
3. Immerse the tablets in the specified disintegration medium at the specified temperature.
4. Activate the apparatus and observe the tablets for disintegration.
5. Record the time taken for complete disintegration of each tablet.
6. Compare the disintegration times against acceptance criteria.
7. Document all testing procedures, observations, and results accurately and comprehensively.
8. Review and approve the test results by authorized personnel.
9. Initiate corrective actions if deviations from acceptance criteria are identified.

Abbreviations Used

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

Documents

• Disintegration 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