SOP for Plant Preventive Maintenance EN-01

The objective of this Standard Operating Procedure for Plant Preventive Maintenance is to establish a systematic approach to preventive maintenance for pharmaceutical manufacturing plants. Preventive maintenance aims to ensure the consistent operation, reliability, and regulatory compliance of critical equipment and systems.Plant Preventive Maintenance

SOP for Plant Preventive Maintenance


1.0             OBJECTIVE:

                   To lay down the Procedure for Plant Preventive Maintenance.

2.0             SCOPE:

                      This SOP is applicable for Preventive Maintenance of Machines / Equipments / Air Handling Units.

                  at ( company name )

 3.0             RESPONSIBILITY:

                   3.1          Officer / Executive Engineering:

                                   3.1.1        To follow SOP.

                                   3.1.2        Preparation of Yearly, Schedule of Plant Preventive Maintenance.

                                     3.1.3        To ensure the execution of Scheduled Plant Preventive Maintenance.

 4.0             ACCOUNTABILITY:

                                4.1          Head Engineering,: Implementation of SOP.

       4.2          Head Production: Implementation of SOP.

 5.0             ABBREVIATIONS:

                    AHU                           Air Handling Unit

EN                               Engineering

Ltd.                             Limited

No.                              Number

QA                              Quality Assurance

SOP                             Standard Operating Procedure

   6.0             PROCEDURE:

  •  Officer/Executive Engineering shall prepare a plant preventive maintenance schedule of Machines/Equipment/Air Handling Units for the calendar year as per Annexure – I. “Yearly Schedule of Plant Preventive Maintenance”.
  •  After approval of Head QA, Officer/Executive QA shall issue the controlled copy to the Engineering department.
  • Officer/ Executive Engineering shall prepare monthly preventive maintenance on the basis of a yearly preventive maintenance schedule as per Annexure-II.Monthly Plant Preventive Maintenance & proposed schedule”.
  •   Officer/Executive Production shall provide a purposed schedule of preventive maintenance on the basis of a yearly preventive maintenance schedule as per Annexure-II.Monthly Plant Preventive Maintenance, proposed schedule & Execution Record”.
  •   After getting consent from the respective department, Officer/Executive Engineering shall plan the preventive maintenance of machines/equipment / AHUs.
  • Officer/Executive Engineering shall do the preventive maintenance of machines/equipment & AHUs as per the respective checklist and record the observation.
  •    Any discrepancy observed during preventive maintenance, shall be communicated to Head Production & Head Engineering and records shall be maintained.
  •   After completion of preventive maintenance, Officer/Executive Engineering shall operate the machine, and equipment and handover to the user department.
  •    Respective Area’s/Section In-charge shall check & verify the performance of equipment/machine, if found satisfactory, duly signed in Annexure-II.
  •    The user department shall clean the equipment/ machine/ AHU after preventive maintenance or breakdown.
  •       Affix the duly filled & signed preventive maintenance card on the machine/ equipment / AHU.
  •     The first Schedule Planner of the year shall have a Revision No. 00 and whenever there will be any changes in the planner due to the addition of machines/equipment then the current version of the planner shall be updated by issuing an addendum from time to time.
  •     This planner shall be revised to the next version (Revision No.) every year while incorporating all the addendums & any new machine/equipment name after the last addendum to the version.
  •       Record of preventive maintenance shall be stored for up to five years.


  • For Monthly preventive maintenance ± 3 days from the due date of Preventive Maintenance.
  • For Quarter preventive maintenance ± 7 days from the due date of Preventive Maintenance.
  •   For Half Yearly preventive maintenance ± 15 days from the due date of Preventive Maintenance.
  •  For Yearly preventive maintenance ± 30 days from the due date of Preventive Maintenance.

7.0              ANNEXURES:

Annexure-I Yearly Schedule of Preventive Maintenance ——————–
Annexure-II Monthly Preventive Maintenance, Proposed Schedule & Execution Record ——————-

8.0            DISTRIBUTION:

·                     Controlled Copy No. 01                     QA Department

·                     Controlled Copy No. 02                     Engineering Department

·                     Master Copy                                       Quality Assurance Department

9.0              REFERENCE:

                      Manufacture User Manuals, TPM.

10.0              REVISION HISTORY:


Revision No.

Change Control No.

Details of Changes

Reason for Change

Effective Date

Updated By




of New SOP

Introduction of new






You may also read about Good Laboratory Practices (GLP)

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