Granule Properties Examination Procedures

1) Purpose

The purpose of this SOP is to outline the procedure for examining granules to ensure they meet the specified properties, such as particle size, flowability, and moisture content, which are critical for consistent product quality and performance.

2) Scope

This SOP applies to all granules produced and used within the pharmaceutical manufacturing facility.

3) Responsibilities

– QC personnel are responsible for conducting tests on granule properties.
– Production personnel must provide samples of granules for testing.
– QA personnel are responsible for reviewing and approving the test results.

4) Procedure

1. Sample Collection
1.1. Collect representative samples of granules from different stages of the production process.
1.2. Ensure samples are collected in clean, dry containers and are properly labeled with batch number, date, and sample point.
2. Particle Size Analysis
2.1. Use a sieving method or laser diffraction method to determine particle size distribution.
2.2. Follow the manufacturer’s instructions for operating the particle size analyzer.
2.3. Record the particle size distribution results and ensure they meet specified ranges.
3. Flowability Testing
3.1. Use a flowability tester, such as a powder flow tester, to assess the flow properties of the granules.
3.2. Perform tests such as angle of repose, compressibility index, and Hausner ratio.
3.3. Document the flowability characteristics and compare them against established specifications.
4. Moisture Content Analysis
4.1. Use a moisture analyzer or loss on drying (LOD) method to determine the moisture content of the granules.
4.2. Weigh a sample of granules and place it in the moisture analyzer.
4.3. Record the moisture content results and ensure they are within the acceptable range.
5. Documentation
5.1. Record all test results on the granule properties test form.
5.2. Include details such as batch number, date of testing, and any observations or anomalies.
5.3. Sign and date the test form.
6. Review and Approval
6.1. Submit the completed test forms to the QA department for review.
6.2. QA will review and approve the results based on the criteria outlined in this SOP.
7. Corrective Actions
7.1. If the granules do not meet the specified properties, initiate a corrective action report.
7.2. Document all actions taken to address issues identified during the testing.

5) Abbreviations, if any

– QC: Quality Control
– QA: Quality Assurance
– LOD: Loss on Drying

6) Documents, if any

– Granule Properties Test Form
– Corrective Action Report Form

7) Reference, if any

– USP <1174> Powder Flow
– FDA Guidance for Industry: Q3C – Quality of Biotechnological Products: Stability Testing of Biotechnological/Biological Products

8) SOP Version

Version 1.0