Standard Operating Procedure for Setup and Validation of Semi-Automatic Tablet Press
| Department | Tablet |
|---|---|
| SOP No. | SOP/TAB/033/2025 |
| Supersedes | SOP/TAB/033/2022 |
| Page No. | Page 1 of 7 |
| Issue Date | 23/07/2025 |
| Effective Date | 28/07/2025 |
| Review Date | 23/07/2026 |
1. Purpose
The purpose of this SOP is to define the procedure for the setup and validation of a semi-automatic tablet press. Proper setup and validation ensure that the tablet press is operating at optimal efficiency, producing tablets that meet the required specifications for weight, hardness, and other critical quality attributes.
2. Scope
This SOP applies to the setup and validation of the semi-automatic tablet press used for tablet production. It includes procedures for equipment setup, operational testing, and ensuring the tablet press meets all required specifications before production runs.
3. Responsibilities
- Manufacturing Personnel: Responsible for setting up the tablet press, ensuring proper calibration, and performing routine checks during production runs.
- Quality Control (QC): Responsible for validating the tablet press setup and ensuring that the tablet quality meets the required specifications (e.g., weight, hardness, appearance).
- Maintenance Personnel: Responsible for ensuring that the tablet press is properly maintained and that all mechanical and electrical components are functioning correctly.
- Quality Assurance (QA): Ensures that the setup and validation procedures are followed according to this SOP, and that the equipment meets regulatory and internal quality standards.
4. Accountability
The Production Manager is accountable for ensuring that the tablet press setup and validation procedures are properly executed. The QA Manager is responsible for reviewing and approving the setup and validation documentation to ensure compliance with GMP standards.
5. Procedure
5.1 Pre-Setup Preparation
- Ensure that the tablet press is clean and free from any previous batch residue. Follow the equipment cleaning SOP to remove all traces of powder or granules.
- Check the tablet press for any visible wear or damage, and verify that all components are properly lubricated and functioning.
- Confirm that the correct tooling (dies and punches) is available for the intended tablet size and shape. Inspect tooling for wear or damage, and replace if necessary.
- Ensure that all necessary raw materials (e.g., granules, excipients) are prepared and ready for the setup process.
5.2 Tablet Press Setup
- Install the correct tooling (dies and punches) on the tablet press, ensuring that the dies are securely mounted in the die holder.
- Set the tablet press parameters, including compression force, feed rate, and tablet weight, according to the product specifications.
- Verify the alignment of the upper and lower punches to ensure they are properly seated and aligned within the die. Adjust if necessary.
- Check that the tablet press is equipped with an adequate dust collection system to prevent contamination and maintain a clean working environment.
- Set up any auxiliary equipment (e.g., tablet deduster, tablet ejector) to ensure proper functioning during production.
5.3 Validation Procedure
- Perform a dry run of the tablet press without any granules to ensure that all components are functioning correctly and that there are no unusual noises or malfunctions.
- Check the tablet press operation for smooth feeding, proper compression, and uniform tablet formation.
- Perform an initial tablet compression test using a small batch of granules. Measure tablet weight, thickness, and hardness to ensure they meet the specifications.
- Verify that the tablet press is operating within the specified parameters for compression force, tablet weight, and speed. Adjust if necessary and repeat the test runs.
- Record the results of the validation tests, including any deviations from the specifications, and document corrective actions taken (Annexure-1).
5.4 Post-Validation Checks
- Once validation is complete, inspect the first batch of tablets for defects such as incomplete tablets, capping, or improper tablet weight.
- If the tablets meet all specifications, continue with the production run. If there are deviations, stop the machine and perform troubleshooting to resolve the issue.
- Monitor the tablet press throughout the production run to ensure that it continues to operate within the validated parameters.
- Document the results of the validation process, including any corrective actions taken, in the batch record (Annexure-2) and validation report (Annexure-3).
5.5 Maintenance of Tablet Press
- Perform routine maintenance checks on the tablet press as per the preventive maintenance schedule (Annexure-4). Ensure that all components are cleaned, lubricated, and inspected for wear.
- Check the calibration of the tablet press regularly to ensure that it continues to operate within the required specifications.
- Ensure that the dust collection and air filtration systems are regularly maintained and that filters are replaced as needed.
- Document all maintenance activities in the equipment maintenance log (Annexure-5).
5.6 Equipment Shutdown
- Once production is complete, stop the tablet press machine according to the equipment shutdown SOP.
- Clean the machine, including all tooling, to remove any leftover powder or granules.
- Record any issues or deviations encountered during production and document any corrective actions taken in the batch record (Annexure-2).
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)
- Validation Report (Annexure-3)
- Preventive Maintenance Log (Annexure-4)
- Equipment Maintenance Log (Annexure-5)
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: Validation Report
| Batch Number | Tablet Type | Tablet Weight | Tablet Hardness | Compression Force | Remarks |
|---|---|---|---|---|---|
| Batch 001 | Tablet A | 250 mg | 5.0 kg | 10 kN | Validation complete, within specifications |
| Batch 002 | Tablet B | 245 mg | 5.2 kg | 10.5 kN | Adjusted compression force |
Annexure-2: Batch Record
| Batch Number | Tablet Type | Tablet Quality | Remarks |
|---|---|---|---|
| Batch 001 | Tablet A | Pass | No issues found |
| Batch 002 | Tablet B | Pass | Adjusted punch alignment |
Annexure-3: Preventive Maintenance Log
| Maintenance Date | Equipment | Maintenance Type | Performed By | Remarks |
|---|---|---|---|---|
| 01/06/2025 | Tablet Press | Routine | John Doe | Lubrication and inspection completed |
| 15/06/2025 | Granulator | Routine | Jane Smith | Cleaned and checked motor |
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 Punch Alignment Procedures | Tooling Wear Monitoring | QA Head |