Purpose

The purpose of this SOP is to outline the procedures for conducting weight variation testing during the tablet/ capsule manufacturing process to ensure uniformity and consistency of capsule/ tablet weight.

Scope

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

Responsibilities

• Quality Control Analysts: Conducting weight variation 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. Select a representative sample of capsules/ tablets according to predefined sampling procedures.
2. Weigh each tablet/ capsule individually using a calibrated balance.
3. Record the weight of each tablet/ capsule and calculate the average weight of the sample.
4. Compare the individual capsule/ tablet weights against the average weight to determine weight variation.
5. Calculate the percentage deviation from the average weight for each capsule/ tablet.
6. Compare the percentage deviation 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

• Weight Variation 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