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 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 Collection and Preparation:
   1. Collect a representative sample of granules from the batch to be tested.
   2. Ensure the sample is properly labeled with batch details and sampling location.
2. Particle Size Analyzer Setup:
   1. Calibrate the particle size analyzer according to the manufacturer’s instructions.
   2. Prepare the dispersion medium as specified for the analyzer.
3. Testing Procedure:
   1. Place the prepared sample into the particle size analyzer and initiate the analysis.
   2. Allow the analyzer to complete the measurement process until all granules are analyzed.
   3. Verify the accuracy and consistency of the results obtained.
4. Data Analysis and Reporting:
   1. Analyze the data generated by the particle size analyzer to determine the granule size distribution.
   2. Calculate and report parameters such as mean particle size, size range, and distribution.
5. Documentation:
   1. Record all testing details, observations, and results in the designated logbook or electronic