Standard Operating Procedure for Conducting Preventive Maintenance on Equipment

1) Purpose

The purpose of this SOP is to provide guidelines for performing preventive maintenance on equipment to ensure its reliable operation, reduce downtime, and extend the equipment’s lifespan in the production of ocular dosage forms.

2) Scope

This SOP applies to all equipment used in the production of ocular dosage forms within the pharmaceutical manufacturing facility, including eye drops, ointments, gels, and inserts.

3) Responsibilities

The responsibilities include planning and scheduling preventive maintenance, performing maintenance tasks, documenting maintenance activities, and ensuring that equipment is operating within specified parameters. Maintenance personnel are responsible for performing and documenting maintenance tasks, and production staff are responsible for coordinating with maintenance personnel to ensure timely maintenance.

4) Procedure

4.1 Planning and Scheduling

1. Develop a preventive maintenance schedule for all equipment based on the manufacturer’s recommendations and operational requirements.
2. Ensure that the maintenance schedule is reviewed and approved by the quality assurance department.
3. Communicate the maintenance schedule to all relevant personnel and ensure that production activities are planned accordingly.

4.2 Preparation

1. Ensure that all maintenance personnel are trained in the proper maintenance procedures for each piece of equipment.
2. Gather all necessary tools, spare parts, and maintenance materials required for the maintenance tasks.
3. Verify that the equipment is clean and free from any contaminants before starting maintenance activities.

4.3 Preventive Maintenance Tasks

1. Equipment Inspection:
   1. Conduct a visual inspection of the equipment for any signs of wear, damage, or abnormalities.
   2. Check for loose or missing parts and tighten or replace them as necessary.
   3. Inspect seals, gaskets, and other components for signs of wear and replace them if necessary.
2. Lubrication:
   1. Lubricate moving parts according to the manufacturer’s recommendations.
   2. Ensure that the correct type and amount of lubricant is used.
   3. Document the lubrication activities in the maintenance logbook.
3. Calibration:
   1. Verify that the equipment is calibrated according to the manufacturer’s specifications.
   2. Adjust the equipment settings as necessary to ensure accurate operation.
   3. Document the calibration activities in the maintenance logbook.
4. Cleaning:
   1. Clean the equipment thoroughly to remove any residues, dust, or contaminants.
   2. Use appropriate cleaning agents and follow safety protocols.
   3. Document the cleaning activities in the maintenance logbook.
5. Functional Testing:
   1. Perform functional tests to ensure that the equipment is operating correctly.
   2. Check for any unusual noises, vibrations, or other signs of malfunction.
   3. Document the results of the functional tests in the maintenance logbook.

4.4 Documentation

1. Record all maintenance activities, including the date, time, and details of the tasks performed, in the maintenance logbook.
2. Ensure that the logbook entries are signed and dated by the maintenance personnel who performed the tasks.
3. Submit the completed maintenance logbook to the quality assurance department for review and approval.

4.5 Review and Approval

1. The quality assurance personnel should review the maintenance logbook for completeness, accuracy, and compliance with SOPs and regulatory requirements.
2. Any discrepancies or deviations should be investigated, documented, and resolved before approving the logbook entries.
3. Once the logbook entries are approved, they should be signed and dated by the quality assurance personnel.

5) Abbreviations, if any

N/A

6) Documents, if any

1. Preventive maintenance schedule
2. Maintenance logbook
3. Calibration records

7) Reference, if any

GMP Guidelines for Equipment Maintenance in Pharmaceutical Manufacturing

8) SOP Version

Version 1.0