Standard Operating Procedure for Particle Size Distribution in Granules

1) Purpose

The purpose of this SOP is to outline the procedure for determining the particle size distribution of granule formulations in the pharmaceutical industry to ensure uniformity and quality.

2) Scope

This SOP applies to all personnel involved in particle size distribution testing of granule formulations within the pharmaceutical quality control (QC) department.

3) Responsibilities

Analytical Chemist: Responsible for performing particle size distribution testing and documenting results.
Quality Assurance (QA) Department: Responsible for reviewing and approving the particle size distribution testing procedure and results.

4) Procedure

1. Sample Preparation:
   1. Select a representative sample of the granule formulation according to sampling plan.
   2. Follow preparation methods that do not alter the particle size distribution.
2. Instrument Setup:
   1. Calibrate the particle size analyzer using calibration standards appropriate for the particle size range.
   2. Ensure the instrument is clean and free from any contaminants.
3. Testing:
   1. Introduce the prepared sample into the particle size analyzer following manufacturer instructions.
   2. Run the analysis to obtain particle size distribution data.
4. Data Analysis:
   1. Analyze the data obtained from the particle size analyzer to determine the distribution of particle sizes.
   2. Calculate parameters such as D10, D50 (median), and D90 to characterize the particle size distribution.
5. Reporting:
   1. Prepare a particle size distribution report summarizing the procedure, results, calculations, and conclusions.
   2. Submit the report to the QA department for review and approval.
6. Documentation:
   1. Maintain accurate records of all particle size distribution testing activities, including raw data, calculations, and reports.
   2. File documentation in accordance with Good Documentation Practices (GDP).

5) Abbreviations, if any

SOP: Standard Operating Procedure
QC: Quality Control
QA: Quality Assurance
D10, D50, D90: Particle size distribution parameters
GDP: Good Documentation Practices

6) Documents, if any

Particle Size Distribution Testing Protocol, Test Results, Particle Size Distribution Report

7) Reference, if any

Pharmacopeial guidelines for particle size distribution testing.

8) SOP Version

Version 1.0