process, collect a representative sample of tablets at regular intervals, typically every 15 minutes or according to the batch record.

The sample size should consist of at least 10 tablets to ensure reliable results.

5.2 Hardness Measurement

1. Measure the hardness of each tablet using a calibrated hardness tester (e.g., a tablet hardness tester that measures the force required to break the tablet).
2. Ensure that the tester is properly calibrated and zeroed before use.
3. Record the hardness value of each tablet and calculate the average hardness for the sample.
4. If applicable, measure the hardness at multiple points on each tablet to ensure uniformity.

5.3 Adjustment of Compression Parameters

1. If the measured hardness deviates from the target range (typically ±10% of the target hardness), adjust the compression machine settings as necessary to bring the tablet hardness within specification.
2. Adjustments may include modifying the compression force, tablet fill weight, or other relevant settings.
3. After making adjustments, re-sample and re-measure the tablet hardness to verify that the adjustments have resulted in tablets meeting the target hardness.

5.4 Monitoring Frequency

1. Tablet hardness should be monitored at regular intervals throughout the compression process, typically every 15 minutes or after processing a set number of tablets (e.g., every 100 tablets).
2. Additional monitoring should be performed if any irregularities or deviations are observed during production.

5.5 Documentation

1. Record all hardness measurements, including individual tablet hardness values, the average hardness, and any adjustments made to the compression machine settings, in the batch record (Annexure-2).
2. Document any deviations from the target hardness and corrective actions taken in the deviation report (Annexure-1).
3. Ensure all records are signed and dated by the responsible personnel and reviewed by QA for compliance.

5.6 Acceptance Criteria

1. The tablet hardness should meet the target hardness specified in the product’s formulation guidelines, typically within ±10% of the target hardness.
2. If the tablet hardness falls outside the acceptable limits, investigate the cause and take corrective actions, which may include reprocessing or rejecting the batch.

5.7 Post-Compression Actions

1. Once the tablet hardness is within specification, proceed with other post-compression processes, such as coating, packaging, and storage.
2. Ensure that any adjustments made to the compression machine are recorded and the equipment is cleaned and calibrated as required.

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 <121> – Tablet Hardness Testing
• 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals (US FDA)
• European Pharmacopoeia (EP) – Specifications for Tablet Hardness

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	Tablet hardness deviation > 10%	Re-adjusted compression force and re-tested	John Doe

Annexure-2: Batch Record

Sample Number	Tablet Hardness (kg)	Average Hardness (kg)	Deviation (%)	Action Taken
Sample 1	6.5	6.4	±1.5%	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 tablet hardness acceptance criteria	Refined quality control processes	QA Head