this SOP. The QA Manager is responsible for approving the final batch after reviewing weight distribution records.

5. Procedure

5.1 Pre-Compression Setup

1. Ensure the tablet press is set up with the appropriate tooling for the batch size.
2. Calibrate the in-line weight monitoring system according to the manufacturer’s specifications to ensure accurate measurements.
3. Verify that the in-line weight monitoring system is properly integrated with the tablet press and that it is correctly measuring the weight of the tablets during compression.
4. Set the acceptable weight limits as per the batch record, ensuring the upper and lower tolerance levels are established.

5.2 Weight Monitoring during Compression

1. Start the compression process and monitor the weight of tablets continuously via the in-line monitoring system.
2. Ensure that the system is recording the weight of each tablet, providing real-time data on the tablet weight during the compression process.
3. Regularly check the data from the weight monitoring system to ensure that the tablets fall within the established weight tolerance limits.
4. If any tablet weight exceeds or falls below the specified limits, adjust the compression force or other relevant parameters to bring the weight back within specifications.
5. Ensure that any adjustments are made promptly to prevent further deviations from the target tablet weight.

5.3 Handling Weight Deviation

1. If tablets fall outside of the weight tolerance range, investigate the cause of the deviation. Potential causes could include incorrect tooling, incorrect material properties, or improper compression force.
2. Document any deviations in the deviation report (Annexure-1) and take corrective actions such as adjusting the tooling, re-calibrating the weight monitoring system, or altering compression settings.
3. If deviations persist, halt production and investigate further to identify and resolve the root cause of the issue.
4. Sample tablets periodically for manual weighing and ensure that the weight data matches the in-line weight monitoring system readings.

5.4 Post-Compression Weight Inspection

1. After compression, perform a final inspection of a sample of tablets to verify that they meet the required weight specifications.
2. Verify the average tablet weight and ensure that it falls within the established specifications in the batch record.
3. If the average weight does not meet the specified requirements, investigate the cause and document the findings in the deviation report (Annexure-1).

5.5 Documentation and Record-Keeping

1. Document all weight monitoring results, including the real-time weight data from the in-line monitoring system and manual weight checks, in the batch record (Annexure-2).
2. Record any deviations from the specified weight limits and corrective actions taken in the deviation report (Annexure-1).
3. Ensure that all records are signed, dated, and retained according to the company’s record retention policy.

5.6 Calibration and Maintenance of Weight Monitoring System

1. Ensure that the in-line weight monitoring system is regularly calibrated according to the manufacturer’s recommendations.
2. Perform routine maintenance on the system, including cleaning and checking for wear and tear on components such as sensors and scales.
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-2)
2. Deviation Report (Annexure-1)
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: Deviation Report

Deviation Date	Batch Number	Deviation Description	Corrective Action	Responsible Person
15/12/2025	Batch 001	Tablet weight out of specification	Adjusted compression force and re-checked weight	John Doe

Annexure-2: Batch Record

Batch Number	Average Weight	Weight Deviation	Hardness	Comments
Batch 001	250 mg	Within specification	7 kg	Weight within limits

Annexure-3: Equipment Maintenance Log

Maintenance Date	Equipment	Maintenance Performed	Performed By	Comments
05/12/2025	In-Line Weight Monitoring System	Calibration and inspection	Jane Smith	System functioning within specifications

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 Compression Settings	Improved Compression Efficiency	QA Head