Standard Operating Procedure for Particle Size Analysis

1) Purpose

The purpose of this Standard Operating Procedure (SOP) is to define the process for performing particle size analysis of pharmaceutical formulations, including Intramuscular (IM) and Subcutaneous (SC) injections, to ensure uniformity and consistency of the product.

2) Scope

This SOP applies to all personnel involved in the particle size analysis of pharmaceutical formulations within the pharmaceutical manufacturing facility. It includes procedures for sample preparation, measurement, and data analysis.

3) Responsibilities

– Analytical Development Team: Responsible for conducting particle size analysis and ensuring accurate results.
– Quality Control (QC) Department: Responsible for verifying and documenting particle size data.
– Quality Assurance (QA) Department: Ensures compliance with SOP and regulatory requirements.

4) Procedure

4.1 Equipment and Materials
4.1.1 Ensure that all equipment used for particle size analysis, such as laser diffraction analyzers, is calibrated and maintained.
4.1.2 Prepare all necessary materials, including samples, solvents, and dispersants.
4.2 Sample Preparation
4.2.1 Obtain representative samples of the formulation as per the sampling plan.
4.2.2 Prepare the sample by dispersing it in an appropriate solvent or dispersant to ensure a uniform suspension.
4.2.3 Sonicate the sample if necessary to break up any agglomerates.
4.3 Measurement
4.3.1 Set up the particle