STANDARD OPERATING PROCEDURE

SOP No.: EN-XX Date of issue

Version No.: 01 PLANNED PREVENTIVE Effective Date

MAINTENANCE
Supersedes: --- Page 1 of 6

PURPOSE:

To provide a procedure for Preventive Maintenance of equipment /Instrument.

RESPONSIBILITY:

Engineering:

1) Preparation of Annual Preventive Maintenance Planner with Production and

Quality Assurance.

2) Carry out Preventive Maintenance activities as per Schedule.

3) After Preventive Maintenance, perform trial for smooth running of machine as per
Standard operating procedure.

4) Support in Investigation, if any abnormalities is observed during Preventive

maintenance.

Concerned Department:

1) Support for preparation of annual Preventive Maintenance planner with

engineering and Quality Assurance.

2) To ensure availability of equipment for preventive maintenance as per planned

schedule.

3) Clearance of equipment for maintenance with respect to safe and clean condition
before and after maintenance activities.

4) Support in Investigation, if any abnormalities is observed during Preventive

maintenance.

Quality Assurance:
1) Issuance of Authorized usage copy of SOP for Preventive maintenance activities
for each equipment and system.

2) Approvals of Preventive Maintenance Planner.

3) Issuance of Preventive maintenance check list to engineering Department for

Preventive maintenance activities.

4) Support in Investigation, if any abnormalities is observed during Preventive

maintenance.
 STANDARD OPERATING PROCEDURE
SOP No.: EN-XX
Approval Date:

Version No.: 01 PLANNED PREVENTIVE

MAINTENANCE
Supersedes: --- Page 2 of 6

1.0 SAFETY

1.1 Follow electrical safety and other applicable safety permits before starting the job.

1.2 Switch ‘OFF’ electrical main switch and put ‘UNDER MAINTENANCE’
board on the main panel.

1.3 Use required Personal Protective equipment as applicable.

1.4 Clean and clear all area and remove all PPM related tags / boards after completion of
maintenance of work.

1.5 Use spark proof tools in highly flammable area like Hydrogenation area of API.

2.0 PROCEDURE:

2.1 Preparation of Standard Operating Procedure for Planned Preventive

Maintenance:

2.1.1 Planned Preventive maintenance SOP should be prepared for all equipment/
Instruments used for Processing, testing and used for other ancillary /supporting
activity.

2.1.2 Planned Preventive maintenance SOP for individual equipment / instrument should
be prepared based on.

2.1.3 Equipment / Instruments Manual.

2.1.4 Machine Manufacturer / Supplier recommendation.

2.1.5 Past experience of same or similar type of equipment /Instruments.

2.1.6 Criticality of maintenance activity of equipment/ Instruments.

2.1.7 Planned Preventive maintenance SOP for each equipment / Instruments should be
finalized as a part of Operational Qualification.

2.1.8 The Planned Preventive maintenance SOP of each equipment / instruments can be
updated if required, based on performance of the machine in routine production and
testing environment.

2.2 Preparation of Preventive Maintenance Planner

2.2.1 All equipment / Instruments should be considered for preparing a PPM planner.
2.2.2 PPM Planner should be version controlled.
Prepared By
Sign / Date: ___________________
 STANDARD OPERATING PROCEDURE
SOP No.: EN-XX
Approval Date:

Version No.: 01 PLANNED PREVENTIVE

MAINTENANCE
Supersedes: --- Page 3 of 6

2.2.3 A typical PPM planner should have following contents.

2.2.4 Header: The Header should contain Title of Document, Version Number and
Supersedes Date.

2.2.5 Text Matter: Sr. No, Equipment Name, Equipment Code No. Months and Dates.

2.2.6 Footer: The Footer should contain Sign of Prepared By, Reviewed By and Approved
By with date. Footer should also contain abbreviations for short form used in PPM
planner

2.2.7 The PPM Planner should be segregated department wise / block wise.

2.2.8 Weekly off days and Holidays should be considered as preferred date for PPM.

2.2.9 The PPM frequency for individual equipment should be as per the respective PPM
SOP. The frequency should be mentioned against each equipment (In the row
provided to mention planned activity ‘P’) as given below.

W : Weekly
F : Fortnightly
M : Monthly
2M : Bi-Monthly
Q : Quarterly
S : Six Monthly
Y : Yearly
2Y : Two Yearly

2.2.10 Every time completion of PPM of each equipment should be indicated by a tick (√ )
Mark against each equipment ( In the row provided to mention completed activity ‘A’)

2.2.11 Whenever new equipment is procured, the detail of equipment and PPM frequency
should be entered manually in the existing PPM planner with sign and date of entry
to be done on left margin of planner .It should be confirmed prior to closeout of
respective change control for the equipment.

2.2.12 Whenever an existing equipment is removed or transferred from one Department/

Site to another Department/ Site , same should be indicated in the planner against
the equipment name as “ Discontinued’ with sign and date of concerned person.

2.2.13 The PPM planner is made before start of the year. New equipment should be hand
written in the amendment and to be added in the following year’s PPM planner and
discontinued equipment should be removed from planner.

Prepared By
Sign / Date: ___________________
 STANDARD OPERATING PROCEDURE
SOP No.: EN-XX
Approval Date:

Version No.: 01 PLANNED PREVENTIVE

MAINTENANCE
Supersedes: --- Page 4 of 6

2.2.14 Once the PPM planner is approved, the previous version should be made obsolete
and should be preserved as per SOP.

2.2.15 Maintenance date can be prepone or postpone within allowed deviation, As there
may be reasons like equipment not available for maintenance, send for repairing etc.
this date should be mentioned in the ‘actual’ (A)’ row. The permissible deviation
varying with frequencies of maintenance is mentioned in the table given below.

Frequency of Maintenance Permissible ± Deviation

W-Weekly ± 1 Day
F-Fortnightly ± 2 Days
M-Monthly ± 3 Days
2M-Bi-Monthly ± 4 Days
Q-Quarterly ± 1 Week
S-Six Monthly ± 2 Week
Y- Annually ± 1 Month

Deviation to be filled if equipment maintenance date exceeds Permissible limit.

2.3 Procedure for Planned Preventive Maintenance activities

2.3.1 Inventory of critical equipment’s spares such as manometer, Relay, RTD sensor,
temperature indicator, gaskets , seals , bearings ,controller etc should be sufficient to
support uninterrupted work.

2.3.2 The PPM should be done by trained maintenance personnel. External agency if
involved in PPM should be accompanied by Cipla engineer and should follow change
room procedure and related work permit system.

2.3.3 PPM of machines carried out by external agencies or original equipment manufacturer
should be supervised by our engineer and service report should be attached. In case
any abnormalities observed during PPM noticed by external agency should be
informed to concerned engineer and investigate through QA.

2.3.4 Tools required for the maintenance activities should be cleaned before and after
maintenance.

2.3.5 Inform the Officer in charge of that area for the availability of the equipment before
starting the PPM activity.

2.3.6 Ensure that there is no left over of product present on the machine and it should be
cleaned before maintenance activity starts.

2.3.7 Carry out the Preventive Maintenance as per the standard operating procedure, work
to be carried out on individual machine and maintain the record for the same.

Prepared By
Sign / Date: ___________________
 STANDARD OPERATING PROCEDURE
SOP No.: EN-XX
Approval Date:

Version No.: 01 PLANNED PREVENTIVE

MAINTENANCE
Supersedes: --- Page 5 of 6

2.3.8 In case any abnormalities in same activity observed during preventive maintenance
three consecutive times frequency of PPM activity should be reviewed between user,
supplier of machine, Quality assurance and Engineering Department.

2.3.9 If any abnormalities observed during preventive maintenance other than specified
checklist, the same to be recorded in remark mentioned in the checklist and should be
reviewed in annual planner, if required.

2.3.10 Quality Assurance should consider such abnormalities as an unplanned activities

occurred during preventive maintenance and should investigate such deviations.

2.3.11 After changing critical components of production equipment of services, it has to be

checked for calibration, proper programming and proper setting before use in
production.

2.3.12 The critical components provided for safe working condition should be rechecked
after the replacement for e.g. limit switches.

2.3.13 After completion of maintenance activities, clean and clear the surrounding area,
machine as well dispose the waste generated like dusters, lubricants, gaskets etc.
Inform to concerned officer in charge to take trial of the equipment as per the
respective SOP.

2.3.14 During test running, equipment operation shall start with the lowest operational
parameters e.g. pressure, temperature, speed; while increasing gradually.

2.4 Critical Aspects of The Planned Preventive Maintenance:

2.4.1 Planned Preventive maintenance of equipment is normally on Sunday’s / Holiday’s or

whenever the equipment is not in use. Copy of PPM Planner to be given to the
concerned department Head for information and co-ordination. If production activities
are planned on any Sunday, maintenance will be carried out in second shift when
production activities are stopped. In case, production area is in use, maintenance will
be carried out immediately after the area is made available.

2.4.2 During maintenance activities, ensure that all the machines in cubicle are not in
operation and without production traces.

2.4.3 During PPM activity, if any abnormal observation or unrepairable system /

components are observed which is required more time, then it should be intimated to
User, Quality Assurance and deviation should be filled.

2.4.4 In case Preventive maintenance needs to be attended in the area which is

pressurized than adjacent rooms then ensure that there are no process activities
going on in surrounding rooms. Quality assurance should evaluate and decide the
operations of nearby machines inside cubicles as well in surrounding areas
depending on the criticality of maintenance activity.
Prepared By
Sign / Date: ___________________
 STANDARD OPERATING PROCEDURE
SOP No.: EN-XX
Approval Date:

Version No.: 01 PLANNED PREVENTIVE

MAINTENANCE
Supersedes: --- Page 6 of 6

2.4.5 Based on machine performance, equipment preventive maintenance schedule can

be reviewed for the increase or decrease in frequency as well addition or deletion of
checking parameters.

3.0 ABBREVIATIONS:
API : Active Pharmaceutical Ingredients
RTD : Resistance Temperature Detector
cGMP : Current Good Manufacturing Practices
4.0 PPM : Planned Preventive Maintenance
No. : Number
SOP : Standard Operating Procedure
e.g. : For example,
Ref. : Reference
ANNEXURES:

Annexure Annexure Name To be used as

Number
EN-XX/A1 Master Planned Preventive Maintenance Schedule: Specimen Copy

Prepared By
Sign / Date: ___________________