SOP for Preventive Maintenance of Production Equipment, Laboratory Instruments and Utilities in Pharmaceuticals

1. Objective:
To lay down a procedure for preventive maintenance of production equipment, laboratory instruments and utilities.
2. Scope:
This procedure is applicable for preventive maintenance of production equipment,
laboratory instruments and utilities.
3. Responsibility
Engineering department
4. Procedure:
4.1 Frequency and procedure for preventive maintenance shall be based on
recommendation from equipment/instrument manufacturer, installation qualification and usage of equipment/instrument.
4.2 Prepare schedule for preventive maintenance.
4.3 Preventive maintenance schedule shall be prepared by maintenance department.
4.4 Schedule shall be reviewed annually and shall be updated in case of any change.
4.5 Checklist of preventive maintenance shall be prepared and maintenance shall be performed as per checklist.
4.6 Concern department head shall be informed before start of preventive maintenance activity.
4.7 For preventive maintenance of non-movable equipment/instrument, ensure production area is not in use and materials are removed.
4.8 Follow the gowning and entry procedure.
4.9 Disconnect the electric supply from the equipment and put “under maintenance” status to start the maintenance activity.
4.10 Replace the part if required and update the equipment history card.
4.11 After completion of maintenance work, remove the “under maintenance” status.
4.12 Take trial of equipment and perform calibration if required.
4.13 Inform the concern department head after completion of the activity.
4.14 Preventive maintenance shall be carried out as per schedule, however + 15 days acceptable from the scheduled date.
4.15 Record the date of preventive maintenance in checklist.
4.16 Preventive maintenance documents shall be retained by QA department.
4.17 Frequency
Six monthly: HVAC, LAF, RLAF, dynamic pass box, dust collector, air curtain, vacuum cleaner
Quarterly: Production and warehouse utility.
6. Annexures:
Annexure I: Preventive maintenance schedule
Annexure II: Preventive maintenance checklist
Annexure III: History card
5. Abbreviations:
QA: Quality assurance
SOP: Standard operating procedure
HVAC: Heating, ventilation and air conditioning
LAF: Laminar air flow
RLAF: Reverse laminar air flow
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