Standard Operating Procedure for Using Multi-Tooling Tablet Press for High Volume Production
| Department | Tablet |
|---|---|
| SOP No. | SOP/TAB/056/2025 |
| Supersedes | SOP/TAB/056/2022 |
| Page No. | Page 1 of 7 |
| Issue Date | 20/11/2025 |
| Effective Date | 25/11/2025 |
| Review Date | 20/11/2026 |
1. Purpose
The purpose of this Standard Operating Procedure (SOP) is to outline the process for using a multi-tooling tablet press to manufacture tablets in high volume production. This SOP ensures efficient operation, consistency in tablet quality, and compliance with GMP standards.
2. Scope
This SOP applies to the use of multi-tooling tablet presses in the tablet manufacturing process. It covers the setup, operation, and maintenance of the tablet press for large-scale tablet production runs.
3. Responsibilities
- Manufacturing Personnel: Responsible for the setup, operation, and monitoring of the multi-tooling tablet press, ensuring tablet production runs smoothly and meets specifications.
- Quality Control (QC): Responsible for inspecting the tablets produced, performing in-process tests for weight, hardness, and uniformity, and ensuring that the final product meets the required specifications.
- Quality Assurance (QA): Ensures that the entire tablet manufacturing process follows this SOP, verifies records, and approves any deviations or adjustments made during production.
- Maintenance Personnel: Responsible for ensuring the tablet press is properly maintained, calibrated, and cleaned according to the prescribed maintenance schedule.
4. Accountability
The Production Manager is accountable for overseeing the tablet manufacturing process and ensuring that the multi-tooling tablet press is used effectively to meet production goals. The QA Manager is responsible for reviewing batch records and approving any changes or adjustments during production.
5. Procedure
5.1 Pre-Production Setup
- Ensure the tablet press is clean and free from any residue from previous production runs. Follow the equipment cleaning SOP to prevent cross-contamination.
- Check that all components of the multi-tooling tablet press, such as punches, dies, and feed mechanisms, are in good condition and properly installed.
- Verify that the appropriate tooling is selected for the specific tablet design (e.g., size, shape) and load it into the tablet press. Ensure that the tools are compatible with the compression force settings required for the batch.
- Set the tablet press parameters, including compression force, feed rate, tablet thickness, and tablet weight, as specified in the batch record.
- Ensure that the granules or powder blend meet the required quality specifications for tablet formation, including particle size and flowability.
5.2 Starting the Tablet Press
- Start the multi-tooling tablet press and monitor the initial operation to ensure that all settings are correct and the press is functioning smoothly.
- Check the tablet weight, thickness, and hardness during the initial production runs to confirm that they meet the required specifications.
- If necessary, adjust the compression force, speed, or tablet thickness to ensure consistent tablet quality.
- Monitor the feed mechanism to ensure that the material is feeding into the die properly, without blockages or uneven filling.
- Record the tablet press settings, including feed rate, compression force, and other relevant parameters in the batch record (Annexure-1).
5.3 Monitoring Production
- During production, monitor the tablets for consistency in weight, thickness, and hardness at regular intervals (e.g., every 30 minutes or per batch requirements).
- If any tablets fall outside of the acceptable weight or thickness range, adjust the compression force or tooling as needed to bring the tablets within specification.
- Ensure that the tablets are free from defects such as capping, lamination, or cracks, which may indicate an issue with the compression settings.
- Record all in-process data, including tablet inspection results and any adjustments made to the machine settings, in the batch record (Annexure-1).
5.4 Adjustments During Production
- If production issues such as tablet weight variability or inconsistent tablet hardness arise, stop the press and check the equipment for any malfunctions or misalignments.
- Adjust the compression force or tablet thickness settings if necessary, and run a test batch to verify the changes.
- If the tablet press continues to experience issues, consult the maintenance team to inspect and resolve any mechanical problems with the press.
- Document any changes to the process, including the reasons for adjustments and the results, in the batch record (Annexure-1).
5.5 Post-Production Checks
- Once production is complete, perform a final check of the tablet weight, thickness, and hardness to ensure that all tablets meet the required specifications.
- Inspect the tablets for any defects such as chips, cracks, or discoloration, which may indicate issues during compression.
- Once the tablets meet specifications, approve the batch for the next manufacturing stage (e.g., coating, packaging).
- If defects are found, investigate the cause, and document any corrective actions taken in the deviation report (Annexure-2).
5.6 Equipment Cleaning and Maintenance
- After production, clean the multi-tooling tablet press thoroughly to remove any residual powder or granules. Follow the equipment cleaning SOP for detailed cleaning procedures.
- Inspect all tooling for wear and damage, and replace any components that may have been worn down during the production run.
- Perform routine maintenance checks according to the tablet press manufacturer’s guidelines and the preventive maintenance schedule.
- Document all cleaning and maintenance activities in the maintenance log (Annexure-3).
5.7 Documentation and Record-Keeping
- Document all production data, including tablet weight, hardness, and thickness measurements, in the batch record (Annexure-1).
- Record any deviations from the prescribed tablet specifications and document the corrective actions taken in the deviation report (Annexure-2).
- Ensure that all records are signed, dated, and stored according to the company’s record retention policy for future audits and inspections.
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-1)
- Deviation Report (Annexure-2)
- 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 | Comments |
|---|---|---|---|---|
| Batch 001 | 10 kN | 500 mg | 7 kg | No deviations |
| Batch 002 | 12 kN | 500 mg | 8 kg | Minor adjustment to compression force |
Annexure-2: Deviation Report
| Deviation Date | Batch Number | Deviation Description | Corrective Action | Responsible Person |
|---|---|---|---|---|
| 20/09/2025 | Batch 003 | Tablet weight outside specification | Adjusted tablet compression force | Jane Smith |
Annexure-3: Maintenance Log
| Maintenance Date | Equipment Component | Maintenance Performed | Performed By | Comments |
|---|---|---|---|---|
| 18/09/2025 | Tablet Press | Lubrication, Calibration | John Doe | Calibration verified, no issues found |
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 Press Settings | Enhanced Production Efficiency | QA Head |