Standard Operating Procedure for Monitoring Tablet Hardness during Compression

Department	Tablet
SOP No.	SOP/TAB/008/2025
Supersedes	SOP/TAB/008/2022
Page No.	Page 1 of 8
Issue Date	20/03/2025
Effective Date	25/03/2025
Review Date	20/03/2026

1. Purpose

This SOP defines the procedure for monitoring the hardness of tablets during the compression process, ensuring tablets meet the required hardness specifications for optimal product quality and performance.

2. Scope

This SOP applies to the monitoring and control of tablet hardness during the compression process in tablet manufacturing, including the use of hardness testers and adjustment of compression force.

3. Responsibilities

• Manufacturing Personnel: Operate tablet compression machines, monitor tablet hardness, and report any deviations to the QA team.
• Quality Control (QC): Perform hardness testing at defined intervals during the compression process and ensure tablets meet the required hardness specifications.
• Quality Assurance (QA): Ensure compliance with this SOP and regulatory requirements, review quality control data, and approve any adjustments made during the process.

4. Accountability

The Production Manager is accountable for ensuring the proper monitoring and control of tablet hardness during compression. The QA Manager is responsible for ensuring adherence to this SOP and reviewing the quality data.

5. Procedure

5.1 Tablet Hardness Monitoring Setup

1. Ensure that the tablet hardness tester is calibrated and in good working condition. Record the calibration data in the equipment log.
2. Check the compression machine to ensure it is properly set up for the required tablet weight, thickness, and hardness specifications.
3. Set the hardness tester to measure the required tablet hardness range (e.g., 4–8 kg). Ensure that the tester is positioned properly to avoid measurement inaccuracies.

5.2 Tablet Hardness Testing

1. During the compression process, test tablet hardness at regular intervals (e.g., every 30 minutes or every 100 tablets) using the hardness tester.
2. Measure the hardness of tablets from different positions in the batch to ensure uniformity. Perform at least three measurements per sample.
3. Ensure that the hardness is consistent with the target specifications for the formulation. If the hardness deviates from the acceptable range, adjust the compression force on the tablet press accordingly.

5.3 Recording Hardness Data

1. Record the tablet hardness measurements in the batch record (Annexure-1) and the QC log (Annexure-2).
2. Include relevant details such as the batch number, tablet hardness values, and any adjustments made to the compression force.
3. Ensure that all records are signed off by the responsible personnel and stored in compliance with regulatory requirements.

5.4 Adjusting Compression Force

1. If the tablet hardness does not meet the required specifications, adjust the compression force on the tablet press.
2. Increase or decrease the force as needed and recheck the tablet hardness after making adjustments.
3. Repeat the hardness test at regular intervals to ensure that the new settings produce tablets within specification.
4. If issues persist, stop the process, investigate potential causes, and rectify them. Document any troubleshooting actions taken in the batch record.

5.5 In-Process Quality Control

1. Ensure that tablets are tested for other critical parameters (e.g., weight, disintegration) in addition to hardness during the compression process to ensure overall tablet quality.
2. Monitor the tablet appearance for any issues such as capping, lamination, or uneven compression. If issues are detected, stop the process and troubleshoot the equipment.

5.6 Tablet Collection and Storage

1. Once the tablets meet the required hardness and other specifications, collect them in containers or bins for the next processing stage (e.g., coating or packaging).
2. Store tablets in a clean, dry environment to prevent degradation or damage before further processing.

5.7 Equipment Shutdown and Cleaning

1. After completing the tablet compression process, shut down the machine and clean the equipment according to the cleaning SOP.
2. Ensure that all components in contact with the tablets are cleaned thoroughly to avoid cross-contamination.

5.8 Documentation and Record-Keeping

1. Document the tablet hardness results, any deviations, and actions taken in the batch record.
2. Ensure all records are reviewed, signed, and retained according to regulatory requirements.

6. Abbreviations

• SOP: Standard Operating Procedure
• GMP: Good Manufacturing Practice
• QC: Quality Control
• QA: Quality Assurance
• CoA: Certificate of Analysis

7. Documents

1. Tablet Hardness Monitoring Batch Record (Annexure-1)
2. Tablet Quality Control Log (Annexure-2)

8. References

• 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals (US FDA)
• EU GMP Guidelines Part I – Basic Requirements for Medicinal Products
• ICH Q7 – Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Tablet Hardness Monitoring Batch Record

Batch Number	Tablet Type	Compression Force	Hardness Test Result	Adjustments Made	Remarks
Batch 001	Tablet A	50 kN	8 kg	None	Within specifications
Batch 002	Tablet B	55 kN	7 kg	Increased compression force	Minor adjustment required

Annexure-2: Tablet Quality Control Log

Batch Number	Test Performed	Result	Test Date	QC Personnel
Batch 001	Hardness Test	Pass	20/03/2025	John Doe
Batch 002	Weight Test	Pass	21/03/2025	Jane Smith

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 Hardness Monitoring Process	Standardization of Monitoring Method	QA Head