Developing Particle Size Methods for Analytical Method Development

1) Purpose

The purpose of this SOP is to outline the procedure for developing particle size methods during the analytical method development process, ensuring accurate measurement of particle size distribution in pharmaceutical formulations.

2) Scope

This SOP applies to all personnel involved in developing particle size methods for analytical method development projects within the analytical development department.

3) Responsibilities

The purpose of this SOP is to define the roles and responsibilities of all personnel involved in developing particle size methods.

4) Procedure

1. Method Development Objectives:
   1. Define objectives for developing particle size methods based on regulatory requirements and product specifications.
   2. Identify appropriate particle size measurement techniques (e.g., laser diffraction, microscopy).
2. Selection of Particle Size Analyzer:
   1. Evaluate and select appropriate particle size analyzer based on sample characteristics and measurement range.
   2. Ensure method capability to detect and measure particles within specified size ranges.
3. Method Optimization:
   1. Optimize method parameters such as dispersion medium, measurement time, and data analysis settings.
   2. Verify method robustness through repeatability and intermediate precision studies.
4. Validation of Particle Size Methods:
   1. Validate particle size methods according to regulatory guidelines and predefined acceptance criteria.
   2. Document validation results and conclusions regarding method suitability for particle size analysis.
5. Documentation and Reporting:
   1. Document all particle size method development activities, including method objectives, analyzer selection, optimization, and validation.
   2. Prepare a particle size method development report summarizing method development activities and outcomes.
6. Review and Approval:
   1. Review the particle size method development report for accuracy, completeness, and compliance with protocol requirements.
   2. Obtain necessary approvals from stakeholders before finalizing the particle size method development report.

5) Abbreviations, if any

The purpose of this SOP is to define the commonly used abbreviations related to particle size method development for analytical method development.

6) Documents, if any

List of documents to be maintained related to this SOP:

• Particle Size Method Development Report
• Validation Results Documentation
• Method Robustness Testing Records
• Review and Approval Records
• Meeting Minutes

7) Reference, if any

Regulatory guidelines related to this SOP include:

• USP General Chapter Particle Size Determination
• ICH Q2(R1): Validation of Analytical Procedures

8) SOP Version

Version 1.0