Standard Operating Procedure for Preventive Maintenance of Tablet Manufacturing Equipment
| Department | Tablet |
|---|---|
| SOP No. | SOP/TAB/049/2025 |
| Supersedes | SOP/TAB/049/2022 |
| Page No. | Page 1 of 6 |
| Issue Date | 16/10/2025 |
| Effective Date | 21/10/2025 |
| Review Date | 16/10/2026 |
1. Purpose
This Standard Operating Procedure (SOP) defines the preventive maintenance procedure for tablet manufacturing equipment to ensure that the equipment operates efficiently, reliably, and in compliance with GMP standards. Preventive maintenance helps to reduce downtime, extend equipment life, and ensure the consistency of tablet production.
2. Scope
This SOP applies to all tablet manufacturing equipment, including tablet presses, coating pans, granulators, blenders, and other associated equipment used in the tablet production process. It includes regular maintenance schedules, checks, cleaning, and documentation practices to ensure optimal equipment performance.
3. Responsibilities
- Manufacturing Personnel: Responsible for reporting any issues with equipment functionality and ensuring that the equipment is operating according to the specified parameters before production runs.
- Maintenance Personnel: Responsible for performing preventive maintenance tasks, including inspections, cleaning, lubrication, calibration, and necessary repairs.
- Quality Control (QC): Responsible for monitoring the performance of the equipment during production and verifying that preventive maintenance tasks are documented and completed according to the schedule.
- Quality Assurance (QA): Ensures that preventive maintenance activities comply with GMP regulations and that all records are complete, accurate, and retained for auditing purposes.
4. Accountability
The Maintenance Manager is accountable for ensuring that all tablet manufacturing equipment receives preventive maintenance according to this SOP. The QA Manager ensures that maintenance activities are properly documented, reviewed, and compliant with GMP standards.
5. Procedure
5.1 Preventive Maintenance Schedule
- Establish a preventive maintenance schedule based on manufacturer recommendations, equipment usage, and historical data. Ensure that all maintenance tasks are performed at regular intervals (e.g., weekly, monthly, quarterly, annually).
- The preventive maintenance schedule should include tasks such as equipment cleaning, lubrication, calibration, parts replacement, and inspections for wear and tear.
- All maintenance activities must be documented, including the date, nature of the work, personnel involved, and any parts replaced.
5.2 Equipment Inspection
- Inspect all tablet manufacturing equipment at the designated intervals to check for any signs of malfunction, wear, or damage. Look for issues such as abnormal noise, vibrations, leaks, or overheating during operation.
- Perform visual inspections on critical components such as seals, belts, gears, motors, and sensors. Check for any signs of corrosion or deterioration that could affect equipment performance.
- Verify that all safety features, such as emergency shut-off switches, alarms, and guardrails, are functional and operational.
5.3 Cleaning and Lubrication
- Perform cleaning and sanitization of equipment regularly to prevent contamination and ensure proper functioning. Use appropriate cleaning agents and follow the equipment-specific cleaning SOPs.
- Lubricate moving parts, such as gears, bearings, and other components, according to the manufacturer’s recommendations to reduce friction and wear.
- Check the lubrication system for leaks or blockages and ensure proper oil levels in all equipment.
5.4 Calibration and Testing
- Calibrate equipment such as tablet presses, weight checkers, and coating pans according to the prescribed intervals to ensure that they are producing tablets within the specified parameters.
- Perform regular tests to verify that equipment is functioning accurately. This includes checking tablet weights, hardness, and other critical specifications, especially after maintenance or calibration work.
- Ensure that calibration results are recorded, including the equipment’s serial number, the calibration date, and the technician responsible for the calibration.
5.5 Parts Replacement
- Replace worn or damaged parts as per the preventive maintenance schedule. Commonly replaced parts include seals, filters, gaskets, and wear plates.
- Ensure that replacement parts are genuine and meet the original equipment specifications to avoid compromising equipment performance or product quality.
- Document all parts replacements in the maintenance log (Annexure-1), including the part number, date of replacement, and reason for replacement.
5.6 Documentation and Record-Keeping
- Complete and maintain a detailed maintenance log for all equipment, documenting each preventive maintenance task performed, including inspection results, cleaning and lubrication details, parts replaced, and any repairs made.
- Ensure that all maintenance records are reviewed and signed off by the maintenance supervisor or authorized personnel.
- Keep records of all preventive maintenance activities for the required retention period to ensure traceability during audits and inspections.
5.7 Corrective Actions
- If a malfunction is detected during a preventive maintenance check, immediately initiate corrective actions, which may include equipment repair, recalibration, or replacement of faulty parts.
- Ensure that any corrective actions are documented in the deviation report (Annexure-2) and that the necessary adjustments are made to prevent future issues.
5.8 Training and Personnel Involvement
- Ensure that all personnel involved in the preventive maintenance of tablet manufacturing equipment are adequately trained in the SOP and in the proper use of tools and safety equipment.
- Provide regular training sessions to update personnel on new maintenance procedures, equipment updates, and safety protocols.
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)
- Deviation Report (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 | Comments |
|---|---|---|---|---|
| 10/09/2025 | Tablet Press | Lubrication, Inspection | John Doe | Lubricated moving parts, no issues found |
| 12/09/2025 | Granulator | Cleaning, Calibration | Jane Smith | Cleaned hopper, recalibrated settings |
Annexure-2: Deviation Report
| Deviation Date | Equipment | Deviation Description | Corrective Action | Responsible Person |
|---|---|---|---|---|
| 14/09/2025 | Tablet Press | Excessive noise during compression | Replaced faulty motor | John Doe |
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 | Improved Equipment Longevity | QA Head |