Standard Operating Procedure for Granule Properties Check

Purpose

The purpose of this SOP is to establish procedures for the systematic evaluation of granule properties in pharmaceutical manufacturing, ensuring compliance with regulatory standards and maintaining product quality.

Scope

This SOP applies to all personnel involved in the manufacturing and quality control of pharmaceutical granules, including operators, technicians, and quality control personnel.

Responsibilities

• Operators: Responsible for executing procedures related to the production of granules and initial granule properties check.
• Technicians: Responsible for conducting detailed granule properties checks and maintaining equipment used in the process.
• Quality Control Personnel: Responsible for monitoring and verifying granule properties for compliance.

Procedure

1. Inspect granulation equipment for any visible damage or defects before each use.
2. Ensure that the equipment is clean, calibrated, and set up according to the approved process parameters for granulation.
3. Verify the quality and specifications of raw materials used in the granulation process.
4. During granulation, monitor and document key process parameters, including but not limited to granulation time, impeller speed, and temperature.
5. Collect samples at specified intervals during granulation for subsequent granule properties analysis.
6. For granule properties check, evaluate characteristics such as particle size distribution, density, and moisture content.
7. Use appropriate testing equipment, such as sieves and moisture analyzers, to perform granule properties checks.
8. Record the results of granule properties checks, including any deviations from the predefined specifications, in the designated logbook or electronic system.
9. If granule properties are out of specification, initiate an investigation, document the findings, and implement corrective actions as needed.
10. Archive granule properties check records in accordance with established retention policies.
11. Regularly review and update granule properties check procedures based on industry standards or process changes.

Abbreviations

No abbreviations are used in this SOP.

Documents

• Granule Properties Logbook
• Calibration Records
• Validation Reports
• Deviation and Corrective Action Logs

Reference

USP General Chapter <1225> – Validation of Compendial Procedures

SOP Version

Version 1.0