Standard Operating Procedure for Particle Size Analysis

Purpose

The purpose of this SOP is to establish procedures for the accurate and consistent analysis of particle size in pharmaceutical products, ensuring compliance with regulatory standards and product quality.

Scope

This SOP applies to all personnel involved in particle size analysis, including laboratory technicians and quality control personnel.

Responsibilities

• Laboratory Technicians: Responsible for conducting particle size analysis following established procedures.
• Quality Control Personnel: Responsible for reviewing and approving particle size analysis results for compliance.

Procedure

1. Inspect the particle size analysis equipment for any visible damage or defects before each use.
2. Ensure that the equipment is clean, calibrated, and properly set up for the specific particle size analysis method to be employed.
3. Prepare the sample to be analyzed according to the approved sampling plan, ensuring representative and homogenous samples.
4. Load the sample into the particle size analysis equipment, following the instrument-specific loading procedure.
5. Run the particle size analysis according to the established method, specifying parameters such as dispersion medium and analysis time.
6. Monitor the instrument during the analysis process, addressing any issues or deviations promptly.
7. Record the particle size analysis results, including size distribution and any other relevant data, in the designated logbook or electronic system.
8. If adjustments to the analysis parameters are necessary, document the changes made and the reason for the adjustments.
9. Perform routine checks and calibrations of the particle size analysis equipment to ensure accurate and reliable results.
10. Perform validation checks if required for the specific particle size analysis method being used.
11. Review the particle size analysis results for compliance with predefined specifications and acceptance criteria.
12. Document any out-of-specification (OOS) results, initiate an investigation, and implement corrective actions as needed.
13. Archive particle size analysis records in accordance with established retention policies.
14. Regularly review and update the particle size analysis method as needed based on industry standards or process changes.

Abbreviations

No abbreviations are used in this SOP.

Documents

• Particle Size Analysis Logbook
• Calibration Records
• Validation Reports
• Deviation and Corrective Action Logs

Reference

USP General Chapter <429> – Design and Development of Bioanalytical Methods

SOP Version

Version 1.0