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 Collection:
   1. Select samples according to the sampling plan from different batches or lots.
   2. Ensure samples are representative of the granule formulation being tested.
2. Apparatus Setup:
   1. Calibrate the flowability tester as per manufacturer’s instructions.
   2. Verify cleanliness of the equipment to avoid any contamination.
3. Testing:
   1. Fill the hopper of the flowability tester with the prepared granule sample.
   2. Set the equipment to the specified conditions (e.g., angle of repose).
   3. Allow the granules to flow through the tester and record the flow time.
4. Measurement:
   1. Record the flow time and any observations related to the behavior of granules (e.g., flow pattern, clumping).
   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. Include any deviations encountered during testing and actions taken.
6. Documentation:
   1. Maintain accurate records of flowability testing activities, including raw data, calculations, and reports.
   2. File documentation following 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