Standard Operating Procedure for Real-Time Tablet Thickness Control
| Department | Quality Control |
|---|---|
| SOP No. | SOP/TAB/123/2025 |
| Supersedes | SOP/TAB/123/2022 |
| Page No. | Page 1 of 6 |
| Issue Date | 01/03/2026 |
| Effective Date | 06/03/2026 |
| Review Date | 01/03/2027 |
1. Purpose
To define the procedure for real-time monitoring and control of tablet thickness during the compression process, ensuring uniformity and adherence to product specifications.
2. Scope
This SOP applies to the real-time monitoring of tablet thickness during the compression process in tablet manufacturing. It ensures that tablets are consistently within the required thickness specifications.
3. Responsibilities
- Quality Control (QC): Responsible for monitoring tablet thickness in real-time, recording measurements, and ensuring the tablets meet the required thickness specifications.
- Compression Operator: Responsible for adjusting compression settings to maintain tablet thickness within specification limits during production.
- Quality Assurance (QA): Reviews the thickness monitoring data and ensures compliance with the required specifications. Investigates deviations and documents corrective actions.
4. Accountability
The QC Manager is accountable for ensuring real-time monitoring and control of tablet thickness during the compression process. The QA Manager is responsible for reviewing records and ensuring compliance with internal and regulatory standards.
5. Procedure
5.1 Sample Collection
- During tablet compression, collect a representative sample of tablets at regular intervals, typically every 15 minutes or after producing a set number of tablets (e.g., every 100 tablets).
- Ensure that the sample size is sufficient for accurate measurements, usually 10 tablets per sample.
5.2 Tablet Thickness Measurement
- Use a calibrated tablet thickness gauge or micrometer to measure the thickness of each tablet in the sample.
- Ensure that the instrument is properly calibrated and zeroed before taking measurements.
- Record the thickness value of each tablet and calculate the average thickness of the sample.
- If applicable, measure the thickness at multiple points on each tablet to ensure uniformity.
5.3 Real-Time Monitoring and Adjustment
- Monitor tablet thickness continuously during the compression process, making adjustments as needed to ensure tablets are within the specified thickness range.
- If the measured tablet thickness deviates from the target thickness (typically ±10% of the target thickness), adjust the compression machine settings accordingly, such as adjusting the compression force, tablet fill weight, or machine speed.
- After adjusting the compression machine, re-sample and measure the tablet thickness to verify that the adjustments resulted in tablets meeting the target thickness.
5.4 Monitoring Frequency
- Tablet thickness should be monitored at regular intervals throughout the compression process, typically every 15 minutes or after every 100 tablets produced.
- If any irregularities are observed, increase the frequency of monitoring until the issue is resolved.
5.5 Documentation
- Record the following information during each tablet thickness monitoring interval:
- Sample number and time of collection
- Individual tablet thickness values
- Average tablet thickness
- Deviation from target thickness and any adjustments made
- Document any deviations from the target thickness and corrective actions taken in the deviation report (Annexure-1).
- Ensure that all records are signed and dated by the responsible personnel and reviewed by QA for compliance.
5.6 Acceptance Criteria
- The tablet thickness should be within the specified range, typically ±10% of the target thickness.
- If the tablet thickness falls outside the acceptable limits, investigate the cause and take corrective actions, including potential rework or rejection of the batch.
5.7 Post-Compression Actions
- Once the tablet thickness is within specification, proceed with the other post-compression processes, such as coating, packaging, and storage.
- Ensure that any adjustments made to the compression machine are recorded and that 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
- Batch Record (Annexure-2)
- Deviation Report (Annexure-1)
8. References
- USP <121> – Tablet Thickness Testing
- 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals (US FDA)
- European Pharmacopoeia (EP) – Specifications for Tablet Thickness
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 thickness deviation > 10% | Adjusted compression force and re-tested | John Doe |
Annexure-2: Batch Record
| Sample Number | Tablet Thickness (mm) | Average Thickness (mm) | Deviation (%) | Action Taken |
|---|---|---|---|---|
| Sample 1 | 4.80 | 4.75 | ±1.2% | 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 thickness acceptance criteria | Refined quality control processes | QA Head |