Purpose

The purpose of this SOP is to outline the procedures for conducting dissolution testing during the Capsule/ tablet manufacturing process to ensure proper release of the active pharmaceutical ingredient (API).

Scope

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

Responsibilities

• Quality Control Analysts: Conducting dissolution 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 dissolution testing apparatus according to manufacturer instructions.
2. Fill dissolution vessels with specified dissolution medium at the specified temperature.
3. Place capsules/ tablets into individual dissolution vessels and start the apparatus.
4. Collect samples at specified time intervals.
5. Analyze samples using appropriate analytical techniques.
6. Calculate the percentage of API released at each time point.
7. Compare dissolution profiles against acceptance criteria.
8. Document all testing procedures, observations, and results accurately and comprehensively.
9. Review and approve the test results by authorized personnel.
10. Initiate corrective actions if deviations from acceptance criteria are identified.

Abbreviations Used

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

Documents

• Dissolution 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