that the preventive maintenance program is being followed correctly and that equipment performance meets the necessary standards for cleaning.

Health and Safety Officer: Ensures that maintenance work is conducted following safety protocols and that proper PPE is used to prevent injury.

4. Accountability

The Manufacturing Manager is accountable for ensuring that preventive maintenance is conducted according to this SOP and that cleaning equipment is maintained in good working condition. Compliance with this SOP is overseen by the Quality Assurance (QA) Manager.

5. Procedure

5.1. Maintenance Schedule

1. Develop and maintain a preventive maintenance schedule for all cleaning equipment. The schedule should be based on the manufacturer’s recommendations and the frequency of use of the equipment.
2. The schedule should include tasks such as equipment inspection, lubrication, calibration, and part replacement.
3. Review the schedule annually and update it as needed based on equipment usage, wear, or operational changes.
4. Ensure that the schedule is clearly communicated to the Maintenance and Production Teams, and ensure that all required tasks are performed on time.

5.2. Routine Maintenance Tasks

1. Inspect all cleaning equipment components for signs of wear or damage. Key components to inspect include:
   • Motors and electrical components
   • Pumps and hoses
   • Valves and seals
   • Filters and air systems
   • Brushes and cleaning heads
2. Clean equipment components to prevent buildup of dirt or debris that could affect performance.
3. Lubricate moving parts according to the manufacturer’s guidelines to reduce friction and wear.
4. Test equipment to ensure that it is operating within the required specifications, such as pressure, temperature, or flow rate.
5. Check and replace any worn or damaged parts, such as seals, hoses, or filters, and document the replacement in the maintenance log (Annexure-1).

5.3. Equipment Calibration

1. For equipment that requires calibration, follow the manufacturer’s instructions to verify that the equipment is within the specified operating range.
2. If calibration results are outside the acceptable range, adjust the equipment as necessary or replace any faulty components.
3. Document the calibration results and any adjustments made in the calibration log (Annexure-2).

5.4. Cleaning Equipment Testing

1. Test the cleaning equipment after maintenance to ensure that it is functioning properly. This includes:
   • Running the equipment through a cycle to check for leaks or malfunctions.
   • Verifying that cleaning solutions or water flow properly through the system and that all components are operating smoothly.
   • Checking for proper pressure or vacuum levels in the cleaning systems.
2. Ensure that any issues identified during testing are documented and addressed before the equipment is put back into service.

5.5. Documentation and Record-Keeping

1. Document all preventive maintenance activities in the Preventive Maintenance Log (Annexure-1), including the date, tasks performed, parts replaced, and any issues encountered.
2. Ensure that the Maintenance Team signs off on all completed tasks and that the records are reviewed by the Quality Control (QC) Team.
3. Maintain a copy of the maintenance log in the document management system for future reference and audits.

5.6. Safety and Environmental Considerations

1. Ensure that all maintenance work is performed following the company’s health and safety policies, including lockout/tagout procedures to prevent accidental equipment activation during maintenance.
2. Ensure that maintenance personnel are equipped with the appropriate Personal Protective Equipment (PPE), including gloves, goggles, and hearing protection, where necessary.
3. Dispose of any waste generated during maintenance (e.g., used lubricants, filters, parts) according to the company’s waste disposal procedures and environmental regulations.

6. Abbreviations

• GMP: Good Manufacturing Practice
• QC: Quality Control
• PPE: Personal Protective Equipment
• SOP: Standard Operating Procedure

7. Documents

1. Preventive Maintenance Log (Annexure-1)
2. Calibration Log (Annexure-2)

8. References

This SOP is based on the following regulatory guidelines and industry standards:

• Good Manufacturing Practice (GMP) Guidelines
• FDA Code of Federal Regulations (CFR) Title 21, Part 211
• ISO 9001:2015 – Quality Management Systems

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Preventive Maintenance Log

Equipment ID	Maintenance Date	Tasks Performed	Parts Replaced	Operator Name
CLE-123	06/02/2025	Lubrication, filter replacement	Filter, hose	Rajesh Patel

Annexure-2: Calibration Log

Equipment ID	Calibration Date	Calibration Results	Operator Name	Remarks
CLE-123	06/02/2025	Pass	Rajesh Patel	No adjustments required

12. Revision History:

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By	Page No.	Ref. Point No.	Details of Revision
01/01/2024	V 1.0	Initial Release	First Issue	Anjali Sharma	Page 1	[Ref Point]	First Release
01/01/2025	V 2.0	Updated preventive maintenance procedures	To comply with updated GMP regulations	Anjali Sharma	Page 1	[Ref Point]	Updated procedures