Standard Operating Procedure for Preventive Maintenance of Tablet Manufacturing Equipment
| Department | Tablet |
|---|---|
| SOP No. | SOP/TAB/032/2025 |
| Supersedes | SOP/TAB/032/2022 |
| Page No. | Page 1 of 7 |
| Issue Date | 18/07/2025 |
| Effective Date | 23/07/2025 |
| Review Date | 18/07/2026 |
1. Purpose
The purpose of this SOP is to outline the procedure for the preventive maintenance of tablet manufacturing equipment. Preventive maintenance ensures that equipment operates efficiently, reduces the likelihood of breakdowns, and extends the lifespan of machinery used in tablet production.
2. Scope
This SOP applies to all tablet manufacturing equipment, including tablet presses, granulators, coating machines, and other associated machinery. It covers routine maintenance, inspections, and preventive measures to keep equipment in optimal condition.
3. Responsibilities
- Maintenance Personnel: Responsible for conducting regular preventive maintenance, performing checks on equipment, and ensuring all maintenance tasks are documented.
- Production Personnel: Responsible for reporting any equipment issues and ensuring that machinery is properly used during production.
- Quality Control (QC): Ensures that the equipment is maintained in a way that meets quality standards and that all preventive maintenance activities comply with GMP standards.
- Quality Assurance (QA): Reviews and approves the preventive maintenance records and ensures that maintenance activities do not impact the quality of production.
4. Accountability
The Production Manager is accountable for ensuring that all preventive maintenance activities are performed on schedule. The QA Manager is responsible for ensuring that maintenance activities do not impact product quality and for reviewing the maintenance records.
5. Procedure
5.1 Maintenance Scheduling
- Establish a preventive maintenance schedule based on the manufacturer’s recommendations, equipment usage, and criticality of the equipment to the production process.
- Ensure that the schedule includes monthly, quarterly, and annual maintenance tasks for all tablet manufacturing equipment, including but not limited to tablet presses, granulators, coating machines, and ancillary systems.
- Coordinate with production and maintenance teams to ensure that maintenance tasks are performed during scheduled downtime or after production shifts to minimize disruption.
5.2 Pre-Maintenance Checks
- Before performing any maintenance, ensure that the equipment is powered off and properly locked out according to the lockout/tagout (LOTO) procedure.
- Verify that all maintenance tools and replacement parts (e.g., lubricants, filters) are readily available before starting the maintenance task.
- Review the previous maintenance log to identify any outstanding issues or specific concerns that need to be addressed during the current maintenance cycle.
5.3 Preventive Maintenance Tasks
- Tablet Press:
- Check and clean the dies and punches to remove any built-up product or granules.
- Lubricate moving parts, including the punch holder and die components, to prevent wear and tear.
- Inspect and calibrate compression force settings to ensure tablet quality.
- Check the tablet press machine for proper alignment of dies and punches.
- Verify the condition of the tooling, replacing any worn-out or damaged components.
- Granulator:
- Clean and inspect the granulation chamber, screens, and agitator for wear or residue buildup.
- Check the lubrication system to ensure it is working properly and add lubricant if necessary.
- Inspect the feeding system for any blockages and ensure that granules are being fed consistently into the granulator.
- Ensure all electrical connections and motors are functioning correctly.
- Coating Machine:
- Check the coating pan for wear or cracks and ensure it is properly aligned.
- Inspect the spray nozzles and clean them if necessary to ensure uniform coating.
- Check the air filtration system to ensure it is free of dust and other contaminants.
- Ensure that all temperature and humidity control systems are operating correctly.
- Auxiliary Systems (e.g., vacuum systems, filtration units):
- Inspect and clean the vacuum systems and dust collection units.
- Check filters for clogging or wear and replace them as necessary.
- Ensure all air filtration systems are running at optimal efficiency.
5.4 Post-Maintenance Checks
- Once the maintenance tasks are complete, perform a test run on the equipment to ensure it is operating correctly and that all systems are functioning as expected.
- Verify that the equipment is clean and free of any maintenance tools or parts left behind during the process.
- Check for any leaks, unusual noises, or malfunctions during the test run and resolve any issues immediately.
- Record the maintenance activities in the equipment maintenance log (Annexure-1) and batch record (Annexure-2), including any corrective actions taken.
5.5 Emergency Maintenance
- If a critical failure occurs during production, stop the machine immediately and follow the emergency maintenance procedure.
- Report the issue to the maintenance team, who will assess the problem and take corrective actions as needed.
- Document the failure, corrective actions, and any impact on production in the maintenance log (Annexure-1).
5.6 Documentation and Record-Keeping
- All preventive maintenance tasks, including inspections, repairs, and replacements, must be documented in the maintenance log (Annexure-1) and the batch record (Annexure-2).
- Ensure that the maintenance records are reviewed and signed off by the appropriate personnel.
- Maintain all records for future audits and quality control checks.
6. Abbreviations
- SOP: Standard Operating Procedure
- GMP: Good Manufacturing Practice
- QC: Quality Control
- QA: Quality Assurance
- API: Active Pharmaceutical Ingredient
7. Documents
- Maintenance Log (Annexure-1)
- Batch Record (Annexure-2)
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: 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 |
Annexure-2: Batch Record
| Batch Number | Tablet Type | Maintenance Status | Tablet Quality | Remarks |
|---|---|---|---|---|
| Batch 001 | Tablet A | Maintained | Pass | No issues found |
| Batch 002 | Tablet B | Maintained | Pass | Adjusted punch alignment |
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 Maintenance Schedule | Routine Equipment Checks | QA Head |