Purpose

The purpose of this SOP is to define the procedures for conducting hardness testing during the tablet manufacturing process to ensure the mechanical strength and integrity of capsules.

Scope

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

Responsibilities

• Quality Control Analysts: Responsible for conducting hardness testing according to this SOP.
• Production Department: Providing tablets for testing and cooperating with quality control personnel.
• Quality Assurance Department: Ensuring compliance with regulatory standards and guidelines.

Procedure

1. Select a representative sample of tablets according to predefined sampling procedures.
2. Place each tablet individually between the anvils of the hardness tester.
3. Apply increasing force until the tablet fractures or deforms.
4. Record the force required to fracture or deform the capsule.
5. Compare the hardness 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

• Hardness 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