SOP for Planned Preventive Maintenance Programme : Pharmaceutical Guidelines

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SOP for Planned Preventive Maintenance Programme

Standard operating procedure to conduct the preventive maintenance of all equipment and instruments used in quality control, manufacturing and utility of the pharmaceutical facility.

1.0 PURPOSE

The purpose of this SOP is to provide stepwise instructions for planned preventive maintenance programme

2.0 SCOPE

This SOP is applicable for the preventive maintenance for all the equipment in the production and utility area.

3.0 RESPONSIBILITY

Technicians are responsible to follow the laid down procedure in a sequential manner. Engineers are responsible to monitor closely and ensure that laid down procedure are followed. Finally, user department and QA should verify completion of Preventive Maintenance activity.

4.0 ACCOUNTABILITY

Head Engineering

5.0 PROCEDURE

5.1 Preparation of the Annual Preventive Maintenance Schedule

5.1.1 The master Annual maintenance schedule shall be prepared for all the critical equipment in the production & utility system, Air Handling Units, Ventilation and exhaust unit. The schedule shall be prepared by Engineer and checked by Engineering Department Head and approved by Head-QA.
5.1.2 The master Annual Filter Cleaning Schedule shall be prepared for all the Air
Handling Units, Ventilation and exhaust unit. Also, all the water tanks cleaning schedule shall be prepared for all the water tanks. The schedule shall be prepared by Engineer & Checked by Engineering Department Head and approved by Head-QA.
5.1.3 The controlled copy of the schedule and Preventive maintenance procedure shall be issued to the engineering department for recording

5.2 Check List

5.2.1 Prepare the checklist for all the critical equipment in the production & utility system,
Air Handling Units, Ventilation and exhaust unit.
5.2.2 The checklist must define all critical assemblies
5.2.3 As per the preventive maintenance schedule, the activity shall be carried out as per the
Checklist with reference to the respective SOP.

5.3 Preventive Maintenance Precautions

5.3.1 Open the panel of the machine & clean it properly
5.3.2 Ensure that the equipment is cleaned & free from the product.
5.3.3 Switch off the main power supply & isolate all the utilities.
5.3.4 A “UNDER PREVENTIVE MAINTENANCE” board display shall be provided at the main power supply of the equipment.
5.3.5 Adequate tools & tackles shall be used.
5.3.6 After the preventive maintenance of all the tools, tackles, worn-out spare shall be removed from the area.
5.3.7 Refer the equipment manufacturer’s manual for identifying the spares, consumable if required..
5.3.8 After the preventive maintenance, take the trial of the equipment.

5.4 Record


5.4.1 The name of the technician shall be indicated in the ‘done by’ column along with the date and the checker shall put his signature in the ‘Checked by’ column along with the date after completion of the activity in ‘Preventive maintenance procedure’ format attached with the SOP of preventive maintenance of respective equipments.
5.4.2 A common format shall be maintained for recording the filter cleaning activities for all the prefilters in the “Filter cleaning area log sheet” however filter cleaning record shall be maintained separately for each equipment, AHU in “Filter cleaning log book” as per SOP.
5.4.3 After completion of the activity, doer (Engineer) and checker Head - Engineering) shall sign the Annual Maintenance Schedule & Annual Filter Cleaning Schedule respectively.
5.4.4 In case the preventive maintenance of any equipment/system could not be completed as per the schedule due to unforeseen reasons, same shall then be completed in the next 15 days, however, the extension for the preventive maintenance shall be approved by Engineering and QA – Head.
5.4.5 Entry of the preventive maintenance details shall be made in the respective equipment log book
5.4.6 In case of introduction of any new equipment, the preventive maintenance of the same shall be part of the annual maintenance schedule and it shall be recorded in the additional annual maintenance & preventive schedule and shall be annexure to the SOP. At the end of the calendar year, the listed equipment shall be incorporated in the next year annual maintenance schedule & preventive schedule.

6.0 ABBREVIATIONS

6.1 SOP: Standard Operating Procedure
6.2 QA: Quality Assurance
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Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
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