Purpose

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

Scope

This SOP applies to all personnel involved in the tablet/ capsule manufacturing process, specifically those responsible for conducting blend uniformity testing.

Responsibilities

• Quality Control Analysts: Responsible for conducting blend uniformity 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. Collect a representative sample of the blend according to defined sampling procedures.
2. Weigh and subdivide the sample as per the specified testing protocol.
3. Prepare samples for analysis using appropriate techniques and equipment.
4. Perform blend uniformity testing using validated methods and instruments.
5. Analyze the results and compare them against established acceptance criteria.
6. Document all testing procedures, observations, and results accurately and legibly.
7. Review and approve the test results by authorized personnel.
8. Initiate appropriate corrective actions in case of deviations from acceptance criteria.

Abbreviations Used

SOP: Standard Operating Procedure
QC: Quality Control

Documents

The following documents are relevant to this SOP:

• Blend Uniformity 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