Standard Operating Procedure for In-Line Weight Monitoring during Compression
| Department | Tablet |
|---|---|
| SOP No. | SOP/TAB/070/2025 |
| Supersedes | SOP/TAB/070/2022 |
| Page No. | Page 1 of 6 |
| Issue Date | 30/01/2026 |
| Effective Date | 04/02/2026 |
| Review Date | 30/01/2027 |
1. Purpose
To outline the procedure for in-line weight monitoring during tablet compression, ensuring that tablets meet the specified weight requirements during the manufacturing process.
2. Scope
This SOP applies to the use of in-line weight monitoring systems during the compression phase of tablet manufacturing to ensure weight uniformity across all tablets in the batch.
3. Responsibilities
- Manufacturing Personnel: Responsible for operating the tablet press, ensuring the in-line weight monitoring system is functioning correctly, and adjusting parameters as necessary.
- Quality Control (QC): Responsible for monitoring the weight distribution of the tablets during the compression process and ensuring that they meet the specified weight tolerances.
- Quality Assurance (QA): Ensures compliance with this SOP and reviews the records for approval of the final batch.
- Maintenance Personnel: Responsible for ensuring that the in-line weight monitoring system is calibrated, maintained, and functioning properly.
4. Accountability
The Production Manager is accountable for ensuring that the in-line weight monitoring system is set up and used according to this SOP. The QA Manager is responsible for approving the final batch after reviewing weight distribution records.
5. Procedure
5.1 Pre-Compression Setup
- Ensure the tablet press is set up with the appropriate tooling for the batch size.
- Calibrate the in-line weight monitoring system according to the manufacturer’s specifications to ensure accurate measurements.
- 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.
- 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
- Start the compression process and monitor the weight of tablets continuously via the in-line monitoring system.
- Ensure that the system is recording the weight of each tablet, providing real-time data on the tablet weight during the compression process.
- Regularly check the data from the weight monitoring system to ensure that the tablets fall within the established weight tolerance limits.
- 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.
- Ensure that any adjustments are made promptly to prevent further deviations from the target tablet weight.
5.3 Handling Weight Deviation
- 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.
- 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.
- If deviations persist, halt production and investigate further to identify and resolve the root cause of the issue.
- 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
- After compression, perform a final inspection of a sample of tablets to verify that they meet the required weight specifications.
- Verify the average tablet weight and ensure that it falls within the established specifications in the batch record.
- 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
- 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).
- Record any deviations from the specified weight limits and corrective actions taken in the deviation report (Annexure-1).
- 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
- Ensure that the in-line weight monitoring system is regularly calibrated according to the manufacturer’s recommendations.
- Perform routine maintenance on the system, including cleaning and checking for wear and tear on components such as sensors and scales.
- 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
- Batch Record (Annexure-2)
- Deviation Report (Annexure-1)
- 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 |