Standard Operating Procedure for Granule Size Distribution Testing

1) Purpose

The purpose of this SOP is to outline the procedure for conducting granule size distribution testing in the pharmaceutical industry to ensure uniformity and consistency of granule sizes.

2) Scope

This SOP applies to all personnel involved in the granule size distribution testing within the pharmaceutical manufacturing department.

3) Responsibilities

Quality Control (QC) Analyst: Responsible for performing granule size distribution testing.
Production Supervisor: Responsible for overseeing the testing process and ensuring compliance.

4) Procedure

1. Sample Preparation:
   1. Collect representative samples of granules from the batch.
   2. Ensure proper labeling and identification of samples.
2. Equipment Setup:
   1. Calibrate the particle size analyzer according to manufacturer’s instructions.
   2. Prepare the dispersion medium as required.
3. Testing Process:
   1. Place the sample in the particle size analyzer and initiate the analysis.
   2. Allow the analyzer to run until all particles are analyzed.
   3. Verify results for accuracy and consistency.
4. Data Analysis:
   1. Review the granule size distribution data generated by the analyzer.
   2. Calculate mean particle size, size range, and distribution parameters.
5. Documentation:
   1. Record all testing parameters, observations, and results in the designated logbook or electronic system.
   2. Prepare a final report summarizing the granule size distribution testing outcomes.

5) Abbreviations, if any

SOP: Standard Operating Procedure
QC: Quality Control

6) Documents, if any

Granule Size Distribution Testing Protocol, Particle Size Analyzer Calibration Records, Testing Logbook

7) Reference, if any

Pharmacopeial guidelines on particle size analysis for pharmaceutical products.

8) SOP Version

Version 1.0