Purpose

The purpose of this SOP is to define the procedures for determining granule size distribution during the tablet/ capsule manufacturing process to ensure product quality and consistency.

Scope

This SOP applies to all personnel involved in the tablet/ capsule manufacturing process, specifically those responsible for assessing granule size distribution.

Responsibilities

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

Procedure

1. Collect representative samples of granules from the manufacturing process.
2. Prepare the samples for analysis by following established procedures for sample preparation.
3. Use appropriate analytical techniques such as sieve analysis or laser diffraction to determine granule size distribution.
4. Record and analyze the results obtained from the granule size distribution analysis.
5. Compare the results against predefined 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

• Granule Size Distribution 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