Standard Operating Procedure for Setup and Validation of Semi-Automatic Tablet Press
| Department | Tablet |
|---|---|
| SOP No. | SOP/TAB/050/2025 |
| Supersedes | SOP/TAB/050/2022 |
| Page No. | Page 1 of 7 |
| Issue Date | 21/10/2025 |
| Effective Date | 26/10/2025 |
| Review Date | 21/10/2026 |
1. Purpose
The purpose of this Standard Operating Procedure (SOP) is to outline the procedure for setting up and validating the semi-automatic tablet press used in the manufacturing of tablets. The SOP ensures that the press operates efficiently and produces tablets that meet quality specifications.
2. Scope
This SOP applies to the setup and validation of the semi-automatic tablet press used in the tablet manufacturing process. It includes setup, adjustment, validation testing, and documentation for ensuring that the press meets required operational standards before and during production.
3. Responsibilities
- Manufacturing Personnel: Responsible for performing the setup of the tablet press, including loading of tooling and setting machine parameters according to the product specifications.
- Quality Control (QC): Responsible for validating the tablet press setup, including performing tests on tablet weight, hardness, and thickness. QC ensures the press meets operational standards before production.
- Quality Assurance (QA): Ensures compliance with this SOP and verifies that the validation results are accurately recorded and reviewed. QA also approves the setup before starting production runs.
- Maintenance Personnel: Responsible for ensuring that the tablet press is in good working condition, conducting preventive maintenance, and ensuring the equipment is ready for operation.
4. Accountability
The Production Manager is accountable for ensuring that the semi-automatic tablet press is set up and validated according to this SOP. The QA Manager is responsible for reviewing validation documentation and approving the setup before production begins.
5. Procedure
5.1 Pre-Setup Preparation
- Verify that the tablet press is clean and free from any residual material from previous production batches. If necessary, clean the machine following the equipment cleaning SOP.
- Ensure that all required tooling (e.g., dies, punches) is available and in good condition. Inspect tooling for wear and tear and replace if necessary.
- Check that the machine is calibrated and all safety features, such as emergency stop buttons, are functional.
- Ensure that the appropriate material for the current batch is available and that the material handling and transfer equipment are prepared.
5.2 Setup of Tablet Press
- Load the correct tooling into the tablet press, ensuring the dies and punches are properly aligned.
- Set the tablet press parameters according to the batch record and product specifications. This includes setting the tablet weight, thickness, hardness, and tablet size.
- Adjust the feed system to ensure the proper amount of powder is fed into the die cavity. Verify the feed rate based on the material and tablet specifications.
- Set the compression force to ensure that the tablets are compressed to the required hardness. Adjust the upper and lower punches accordingly.
- Adjust the ejection mechanism to ensure that tablets are properly ejected without damaging the tablets or the machine.
5.3 Validation Testing
- Perform initial test runs to validate the tablet press setup. Check for proper tablet formation, uniformity, and absence of defects such as capping, laminating, or chipping.
- Perform the following tests on a sample of tablets:
- Tablet weight variation
- Tablet hardness
- Tablet thickness
- Friability
- If any of the test results fall outside the specified limits, adjust the tablet press settings and perform another test run until the parameters are within acceptable ranges.
- Verify that the tablet press settings and adjustments are within the manufacturer’s specifications and documented in the batch record (Annexure-1).
5.4 Final Setup Approval
- Once all validation tests meet the specified parameters, the setup is reviewed by Quality Assurance (QA) for approval.
- QA will review the batch record and validation results. If the results are satisfactory, QA will approve the setup for production.
- If any issues are identified during the review, corrective actions must be taken before the setup is approved. The deviation report (Annexure-2) must be completed, and the corrective actions documented.
5.5 Ongoing Monitoring During Production
- Once the tablet press is validated and production begins, QC personnel will continue to monitor the tablet press parameters and product quality throughout the production run.
- Regular checks should include monitoring tablet weight, hardness, and thickness to ensure that the press continues to operate within the required specifications.
- Document any deviations or adjustments made during production in the batch record (Annexure-1). If deviations occur, a deviation report (Annexure-2) must be completed.
5.6 Post-Production Equipment Check
- After production, the tablet press should be cleaned following the equipment cleaning SOP to prevent cross-contamination between batches.
- Perform a post-production inspection to ensure that the tablet press is free from any powder residue and that all tooling is cleaned and properly stored.
- Document all post-production maintenance and inspections in the 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-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 | Tablet Type | Press Settings | Test Results | Comments |
|---|---|---|---|---|
| Batch 001 | Tablet A | Weight: 500 mg, Hardness: 8 kg | Weight: Pass, Hardness: Pass, Thickness: Pass | No deviations |
| Batch 002 | Tablet B | Weight: 600 mg, Hardness: 9 kg | Weight: Pass, Hardness: Pass, Thickness: Pass | No deviations |
Annexure-2: Deviation Report
| Deviation Date | Batch Number | Deviation Description | Corrective Action | Responsible Person |
|---|---|---|---|---|
| 10/09/2025 | Batch 003 | Tablet hardness outside acceptable range | Adjusted compression force | John Doe |
Annexure-3: Maintenance Log
| Maintenance Date | Equipment Component | Maintenance Performed | Performed By | Comments |
|---|---|---|---|---|
| 12/09/2025 | Tablet Press | Lubrication, Inspection | Jane Smith | No issues found, lubricated moving parts |
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 | Improved Production Consistency | QA Head |