addressed.

Quality Assurance (QA) Team: Ensures that preventive maintenance activities are performed according to this SOP, verifies maintenance records, and ensures compliance with regulatory standards.

4. Accountability

The Capsule Manufacturing Supervisor is accountable for ensuring that preventive maintenance activities are carried out as scheduled. The QA Manager is responsible for ensuring compliance with this SOP and reviewing maintenance documentation.

5. Procedure

5.1 Pre-Maintenance Preparation

Before beginning any preventive maintenance task, ensure the following steps are completed:

1. Equipment Shutdown
   1. Ensure that the equipment to be serviced is properly shut down and that all safety procedures are followed. Disconnect electrical power if necessary and lock out/tag out the equipment to prevent accidental start-up.
2. Review Maintenance Schedule
   1. Review the maintenance schedule to ensure that the correct tasks are being performed on the equipment at the correct intervals. Maintenance schedules should be based on the manufacturer’s recommendations and the operating history of the equipment.
3. Tools and Spare Parts
   1. Ensure that all necessary tools, spare parts, and lubricants are available before beginning the maintenance work. Use only approved parts and materials for repairs or replacements.

5.2 Preventive Maintenance Tasks

Perform the following preventive maintenance tasks at the recommended intervals to ensure optimal performance of capsule manufacturing equipment:

1. Cleaning
   1. Clean all equipment parts, including capsule filling machines, hoppers, and capsules inspection units. Use approved cleaning agents and follow cleaning procedures to prevent contamination and ensure smooth operation.
2. Lubrication
   1. Lubricate all moving parts, including gears, motors, and conveyor systems, according to the manufacturer’s specifications. Use appropriate lubricants and check for signs of wear or damage to moving parts.
3. Inspection and Calibration
   1. Inspect equipment for wear, corrosion, or other damage. Calibrate systems such as weight sensors, filling mechanisms, and sealing units to ensure that the equipment operates within specified tolerances.
4. Check Electrical Systems
   1. Inspect all electrical connections, circuits, and components for signs of damage or overheating. Test the electrical systems to ensure proper functionality.
5. Inspect Air and Gas Systems
   1. Inspect pneumatic systems, air filters, and gas lines for leaks or blockages. Replace filters as needed to ensure a constant supply of clean air to the equipment.
6. Check for Alignment and Calibration
   1. Check the alignment of all mechanical components, including the capsule filling stations and sealing mechanisms. Ensure that all components are correctly aligned to prevent misalignment during production runs.

5.3 Post-Maintenance Verification

After completing the preventive maintenance tasks, perform the following steps:

1. Equipment Testing
   1. Test the equipment to ensure that it is functioning correctly after maintenance. Run a test batch of capsules to verify that the machine is operating smoothly and within specified parameters.
2. Verification of Adjustments
   1. Verify that any adjustments made during maintenance (e.g., machine settings, calibration) are correct. Document the adjustments made and any changes to equipment parameters.
3. Documentation
   1. Document all preventive maintenance activities in the equipment maintenance log. Include the date, tasks performed, parts replaced, and any issues identified during the maintenance process. Include the results of post-maintenance testing and verification.

5.4 Frequency of Preventive Maintenance

The frequency of preventive maintenance tasks depends on the manufacturer’s recommendations, equipment usage, and criticality. Ensure the following tasks are performed at regular intervals:

1. Daily
   • Visual inspection of equipment for damage or wear
   • Cleaning of equipment surfaces and components
   • Lubrication of moving parts as required
2. Weekly
   • Calibration checks on weight sensors, filling mechanisms, and sealing machines
   • Inspection of air filters and pneumatic systems
3. Monthly
   • Full system inspection, including electrical systems and mechanical components
   • Replacement of worn parts and filters

5.5 Emergency Maintenance

In case of unexpected breakdowns or equipment failure, follow these steps:

1. Shutdown and Isolation
   1. Immediately shut down the equipment and isolate it from the production line to prevent further damage or safety hazards. Ensure that all electrical power is disconnected and the equipment is locked out for safety.
2. Assessment and Repair
   1. Assess the cause of the breakdown and repair the equipment as quickly as possible. If necessary, call in specialized maintenance personnel to address the issue.
3. Post-Repair Testing
   1. Once repairs are made, test the equipment to ensure that it is fully operational and that no further issues exist. Verify that the equipment is running smoothly and within the specified operational parameters.
4. Documentation
   1. Document the cause of the breakdown, the repair actions taken, and the outcome of the post-repair testing. Include any adjustments made to the equipment during repairs.

5.6 Documentation and Record-Keeping

It is essential to maintain accurate records of all preventive maintenance activities:

1. Equipment Maintenance Log
   1. Document all preventive maintenance activities in the equipment maintenance log, including the tasks performed, parts replaced, and any corrective actions taken.
2. Maintenance Request Form
   1. For any non-routine maintenance or repairs, complete a maintenance request form detailing the issue, the urgency of the repair, and any necessary parts or tools.
3. Calibration and Inspection Records
   1. Keep records of all calibration and inspection activities for each piece of equipment, including the results and any corrective actions taken.

6. Abbreviations

• SOP: Standard Operating Procedure
• GMP: Good Manufacturing Practice
• QC: Quality Control
• QA: Quality Assurance

7. Documents

1. Equipment Maintenance Log (Annexure-1)
2. Maintenance Request Form (Annexure-2)
3. Calibration and Inspection Records (Annexure-3)

8. References

• USP <1163> – Pharmaceutical Dosage Forms: Capsules
• FDA Guidelines for Capsule Manufacturing
• International Conference on Harmonization (ICH) Guidelines for Pharmaceutical Manufacturing

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Equipment Maintenance Log

Equipment ID	Maintenance Date	Tasks Performed	Parts Replaced	Technician
Filling Machine 1	01/02/2025	Cleaned, calibrated sensors	None	John Doe

Annexure-2: Maintenance Request Form

Request ID	Equipment ID	Issue Description	Urgency Level	Requested By
REQ-001	Filling Machine 2	Motor overheating	High	Manufacturing Supervisor

Annexure-3: Calibration and Inspection Records

Equipment ID	Calibration Date	Technician	Calibration Results
Filling Machine 1	01/02/2025	John Smith	Within Tolerance

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 preventive maintenance tasks	Standardization	QA Head