Standard Operating Procedure for Particle Size Distribution in Gels

1) Purpose

The purpose of this SOP is to define procedures for determining the particle size distribution of particulate matter in gel products to ensure consistency and quality.

2) Scope

This SOP applies to all personnel involved in particle size distribution analysis of gels within the pharmaceutical manufacturing facility.

3) Responsibilities

Quality Control (QC) Analyst: Perform particle size distribution analysis according to this SOP.
Formulation Scientists: Provide input on method selection and optimization.
Quality Assurance (QA) Team: Review and approve particle size distribution procedures and results.

4) Procedure

4.1 Sample Preparation
4.1.1 Prepare samples following specified dispersion techniques to ensure representative analysis.
4.1.2 Ensure samples are appropriately diluted and well-mixed prior to analysis.

4.2 Particle Size Measurement
4.2.1 Use validated particle sizing techniques such as laser diffraction, microscopy, or sieving.
4.2.2 Perform measurements under controlled conditions to minimize variability.

4.3 Data Collection and Analysis
4.3.1 Collect particle size distribution data across specified size ranges.
4.3.2 Analyze data to determine mean particle size, distribution width, and other relevant parameters.

4.4 Reporting and Documentation
4.4.1 Document particle size distribution testing procedures, results, and analysis.
4.4.2 Maintain comprehensive and traceable records of particle size distribution for batch records and regulatory compliance.

5) Abbreviations, if any

SOP: Standard Operating Procedure
QC: Quality Control
QA: Quality Assurance

6) Documents, if any

– Particle Size Distribution Records
– Method Validation Reports
– SOP for Sample Preparation

7) Reference, if any

– USP General Chapter <429> Light Diffraction Measurement of Particle Size
– ICH Q2(R1): Validation of Analytical Procedures
– Company-specific particle size distribution guidelines

8) SOP Version

Version 1.0