follows this SOP and that any deviations from standard process parameters are documented and resolved.

Maintenance Personnel: Responsible for ensuring the tablet press is calibrated and in good working condition, and that all related equipment used in the compression process is functioning properly.

4. Accountability

The Production Manager is accountable for overseeing the tablet compression process, ensuring that the end-point is accurately detected, and confirming that the tablets meet the required specifications. The QA Manager is responsible for verifying compliance with the SOP and ensuring that all deviations are addressed and documented.

5. Procedure

5.1 Preparing for Compression

1. Ensure that the tablet press is clean and calibrated before starting the compression process. Verify that the tablet press settings are aligned with the batch record specifications.
2. Prepare the granules or powder blend for compression, ensuring that it meets the required specifications for flowability, particle size distribution, and moisture content.
3. Ensure that the correct tooling (punches and dies) is installed, and confirm that the tablet press is configured for the correct tablet shape and size as per the batch record.
4. Set the tablet press parameters, including compression force, tablet thickness, and feed rate, as specified in the batch record.

5.2 Detecting the End-Point of Compression

1. During the compression process, monitor the key tablet characteristics that determine when to stop the compression, including:
   • Tablet weight
   • Tablet hardness
   • Tablet thickness
2. Monitor tablet hardness using a hardness tester or in-line measurement system at regular intervals during the compression process.
3. Check tablet weight consistency using a balance or in-line weight measurement system at regular intervals during the compression process.
4. Monitor tablet thickness and ensure it remains consistent according to the established parameters.
5. Once tablets meet the predefined hardness, weight, and thickness criteria, stop the compression process to prevent over-compression, which could lead to defects or unacceptable tablet properties.

5.3 In-Process Monitoring

1. During the compression process, regularly sample tablets for in-process testing. Measure tablet weight, hardness, and thickness at intervals defined in the batch record (e.g., every 30 minutes or after a specified number of tablets).
2. If any of the tablet characteristics fall outside the acceptable range, stop the compression process and investigate the cause.
3. Adjust the compression force, feed rate, or tooling if necessary to bring the tablets back into specification.
4. Once the tablets meet the required specifications, document the end-point detection and the settings used for compression.

5.4 Final Verification of Tablet Quality

1. After the compression process has been stopped, conduct a final check of the tablet characteristics to confirm that the tablets meet the established specifications.
2. Perform tablet hardness, weight, and thickness testing on a representative sample of tablets from the batch.
3. Verify that the tablets have a uniform appearance and do not exhibit defects such as capping, lamination, or cracking.
4. If any tablets fail to meet the specifications, reject the batch or perform rework as necessary according to the batch record and deviation report (Annexure-2).

5.5 Documentation and Record-Keeping

1. Record all relevant data, including compression settings, tablet weight, hardness, thickness measurements, and any adjustments made during the process, in the batch record (Annexure-1).
2. Document any deviations from the prescribed process in the deviation report (Annexure-2), and describe the corrective actions taken.
3. Ensure that all records are signed, dated, and stored according to the company’s record retention policy for future audits and inspections.

5.6 Calibration and Maintenance of Compression Equipment

1. Ensure that the tablet press is regularly calibrated to maintain accurate tablet weight, hardness, and thickness measurements.
2. Perform routine maintenance checks on the tablet press according to the preventive maintenance schedule to ensure optimal performance and minimize the risk of equipment malfunction.
3. Document all calibration and maintenance activities in the equipment maintenance log (Annexure-3).

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-1)
2. Deviation Report (Annexure-2)
3. Equipment Maintenance Log (Annexure-3)

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: Batch Record

Batch Number	Compression Force	Tablet Weight	Tablet Hardness	Tablet Thickness	End-Point Detection Notes
Batch 001	10 kN	500 mg	7 kg	4 mm	Compression stopped after achieving target hardness and weight

Annexure-2: Deviation Report

Deviation Date	Batch Number	Deviation Description	Corrective Action	Responsible Person
18/12/2025	Batch 002	Tablet hardness outside target range	Adjusted compression force	John Doe

Annexure-3: Equipment Maintenance Log

Maintenance Date	Equipment Component	Maintenance Performed	Performed By	Comments
10/12/2025	Tablet Compression Machine	Calibration and Tooling Inspection	Jane Smith	Calibration verified, tooling in good condition

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 End-Point Detection Parameters	Optimized Process	QA Head