Standard Operating Procedure for Lubrication Testing in Tablet Granules

Department	Tablet
SOP No.	SOP/TAB/136/2025
Supersedes	SOP/TAB/136/2022
Page No.	Page 1 of 6
Issue Date	01/03/2026
Effective Date	06/03/2026
Review Date	01/03/2027

1. Purpose

To define the procedure for testing the lubrication properties of tablet granules to ensure proper flowability, ease of compression, and tablet release during manufacturing.

2. Scope

This SOP applies to the testing of granules’ lubrication properties during tablet manufacturing. It ensures that granules have sufficient lubrication for proper tablet compression and release.

3. Responsibilities

• Quality Control (QC): Responsible for performing lubrication testing on tablet granules to ensure they meet the required lubrication properties for compression.
• Granulation Operator: Responsible for adding the correct amount of lubricant to the granules and ensuring that the granules are thoroughly mixed to achieve uniform lubrication.
• Quality Assurance (QA): Ensures that the lubrication testing procedure is conducted properly, reviews results, and confirms compliance with quality standards.

4. Accountability

The QC Manager is accountable for ensuring that lubrication testing is performed accurately during the tablet granulation process. The QA Manager is responsible for reviewing the test results and ensuring compliance with the required specifications.

5. Procedure

5.1 Lubrication Testing Method

1. After the granulation process, take a representative sample of granules from different points of the batch (top, middle, and bottom).
2. Weigh the granules before and after the addition of the lubricant to determine the amount added.
3. Test the granules for lubrication properties using methods such as the “Flowability Test” or the “Compressibility Test” to assess the impact of lubrication on the granules’ ease of flow and compressibility.

5.2 Flowability Test

1. To perform the flowability test, measure the flow rate of the granules using a powder flow tester or a similar device designed to measure the ease of flow.
2. The granules should flow easily and consistently without clumping or excessive friction.
3. Record the flow rate and compare it with the specified requirements. Granules with poor flowability may indicate insufficient lubrication, and adjustments should be made.

5.3 Compressibility Test

1. Conduct a compressibility test to assess how well the lubricated granules compress under pressure. This can be done using a tablet press or similar equipment.
2. The granules should compress easily into a tablet without causing excessive friction or damage to the equipment.
3. Record the compression force and tablet weight. Granules with poor compressibility may require an increase in lubrication.

5.4 Moisture Content Test

1. Test the moisture content of the granules after lubrication to ensure that the lubricant is evenly distributed. Excess moisture may affect the lubrication properties and cause problems during compression.
2. Granules should have a moisture content within the acceptable range, typically between 3% and 7%, depending on the formulation.

5.5 Adjustments and Corrective Actions

1. If the lubrication properties are not within the desired range, adjust the amount of lubricant added to the granules or modify the mixing process to ensure better distribution.
2. If poor flowability or compressibility persists, consider using a different lubricant or modifying the granulation conditions, such as granule size or binder concentration.
3. Re-test the granules after making adjustments and verify that the lubrication properties meet the required specifications.

5.6 Documentation

1. Document the results of the lubrication tests, including flowability, compressibility, and moisture content, in the batch record (Annexure-2).
2. Any deviations from the desired lubrication properties should be documented in the deviation report (Annexure-1), along with corrective actions taken.
3. Ensure that all records are signed, dated, and reviewed by QA to verify compliance with quality standards.

5.7 Acceptance Criteria

1. The granules should exhibit good flowability, compressibility, and moisture content within the specified range.
2. If any test result fails to meet the specified criteria, corrective actions must be taken, and the granules should be re-tested after adjustments.

5.8 Post-Granulation Actions

1. Once the granules pass the lubrication tests, proceed with the next stages of tablet manufacturing, such as compression, drying, and coating.
2. Ensure that all equipment used for lubrication testing is cleaned and calibrated regularly according to the preventive maintenance schedule.

6. Abbreviations

• SOP: Standard Operating Procedure
• GMP: Good Manufacturing Practice
• QC: Quality Control
• QA: Quality Assurance
• API: Active Pharmaceutical Ingredient

7. Documents

1. Batch Record (Annexure-2)
2. Deviation Report (Annexure-1)

8. References

• USP <616> – Lubricant Testing for Granules and Tablets
• 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals (US FDA)
• European Pharmacopoeia (EP) – Granule Lubrication and Flowability Specifications

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Deviation Report

Deviation Date	Batch Number	Deviation Description	Corrective Action	Responsible Person
15/12/2025	Batch 001	Poor flowability of granules	Adjusted binder concentration and re-sampled	John Doe

Annexure-2: Batch Record

Sample Number	Flowability Test Result	Compressibility Test Result	Moisture Content	Action Taken
Sample 1	Pass (Good flowability)	Pass (Compressible)	5.0%	Accepted

Revision History:

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
01/01/2024	1.0	Initial Version	New SOP Creation	QA Head
01/02/2025	2.0	Updated lubrication testing method	Improved testing procedure	QA Head