Standard Operating Procedure for Flowability Testing in Granules

1) Purpose

The purpose of this SOP is to outline the procedure for assessing the flowability of granule formulations in the pharmaceutical industry to ensure proper handling and processing.

2) Scope

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

3) Responsibilities

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

4) Procedure

1. Sample Preparation:
   1. Select a representative sample of the granule formulation according to sampling plan.
   2. Ensure the sample is free from clumps and aggregates.
2. Apparatus Setup:
   1. Calibrate the flowability tester according to manufacturer instructions.
   2. Ensure the apparatus is clean and free from any residue.
3. Testing:
   1. Fill the hopper of the flowability tester with the prepared sample.
   2. Set the tester to the appropriate operating conditions (e.g., angle of inclination).
   3. Allow the sample to flow through the tester and measure the flow time.
4. Measurement:
   1. Record the flow time and any observations related to sample behavior (e.g., cohesive or free-flowing).
   2. Calculate flowability indices if required (e.g., Hausner ratio, Carr’s index).
5. Reporting:
   1. Document the flowability test results in the appropriate logbook or electronic system.
   2. Note any deviations or issues encountered during testing.
6. Documentation:
   1. Maintain accurate records of all flowability 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
GDP: Good Documentation Practices

6) Documents, if any

Flowability Testing Protocol, Test Results, Flowability Report

7) Reference, if any

Pharmacopeial guidelines for flowability testing of pharmaceutical granules.

8) SOP Version

Version 1.0