CSH Pharmaceuticals (Pvt.) Ltd. Lahore.

SOP NO. ENG/GEN-001/01

STANDARD OPERATING PROCEDURE

ENGINEERING DEPARTMENT

Title: PREVENTIVE MAINTENANCE OF PLANT & EQUIPMENT

Issue Date Review Date Supersedes Version No of Pages

February, 2019 ENG-015/03 01 10

Original : Quality Assurance Manager

Copies To : Engineering Manager
: Mechanical workshop

Prepared by Checked by Approved by Authorized by

Engineering Officer Engineering Manager QA Manager Plant Director

Date Date Date Date

CONFIDENTIALITY: All the SOPs should be treated confidential and shall not be shown to unauthorized persons.
 CSH Pharmaceuticals (Pvt.) Ltd. Lahore
SOP NO. ENG/GEN-001/01
1. OBJECTIVE
This procedure outlines the method for administration of equipment predictive/preventive
maintenance program.
2. REASON
2.1. To describe the minimum GMP requirements for a site maintenance schedule.
2.2. To ensure that lubricants, seals, gaskets, filters or other product contact Items used in
manufacturing areas are not sources of significant product contamination.
2.3 To ensure that equipment used for the control and release of product is suitably maintained.
2.4 To describe an authorized procedure for maintenance of plant and equipment according to
master preventive maintenance schedule.
3. SCOPE
This procedure applies to all plant equipment in CSH Pharmaceutical (Pvt.) Ltd. Lahore
4. ENVIRONMENTAL, HEALTH AND SAFETY PROTECTION
There are no significant hazards or special instructions relating to the process/activities
described in this SOP.

5. ROLES & RESPONSIBILITIES

Roles Responsibilities
 Assessing new equipment to confirm whether the new
equipment is GMP plant item.
 Keeping Preventive Maintenance tasks and schedules up-
to-date and current in accordance with equipment
Senior Officer / reductive/preventive maintenance program Responsible
Supervisor for break down and preventive maintenance of all
machines
 Execution of preventive maintenance work orders,
updating of maintenance information and generating all
relevant reports.
Engineering Manager  Engineering Manager is responsible for the overall
administration of equipment preventive maintenance
program
 Engineering Manager is responsible for planning and
scheduling of preventive maintenance tasks based on
predictive/preventive maintenance schedule and
Preventive Maintenance Master Plan
 To ensure implementation of this SOP.

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 CSH Pharmaceuticals (Pvt.) Ltd. Lahore
SOP NO. ENG/GEN-001/01
 To ensure that the procedure follows the details noted in
the SOP
 .After any maintenance QA will be verify and assure the
cleanliness and usability of equipment
Quality Assurance  To approve the SOP prior to its use and ensure
Manager implementation of this SOP.
 To ensure that all routine operations and activities in their
area are documented by SOPs
6. PROCEDURE
6.1 Development and Control of Equipment Master List
The objective of this step is to generate a list of plant and equipment at site with unique
identification and categorizations.
6.1.1 Master list of equipment will comprise of all equipment at plant with unique
identification will be given by using SAP system (Appendix-1).
6.1.2 Manager Engineering will be the owner of the Equipment Master Lists.
6.1.3 The Equipment master list will be a live document & can be updated when new
equipment received.
6.2 For New Equipment
6.2.1 A criticality study shall be performed on all new equipment (Mechanical,
Electrical and Instrumentation) to determine criticality of the new equipment
(i.e. impact on product quality, production capability, safety, etc.)
6.2.2 A formal and structured Failure Modes and Effects Analysis (FMEA) study shall
be performed on all critical equipment.
6.2.3 Based on the results of criticality and FMEA studies appropriate preventive
maintenance program shall be developed for the installed and commissioned
equipment (the use of appropriate maintenance strategies and predictive
maintenance systems/tools should be incorporated).
6.2.4 The Engineering Manager shall prepare the preventive maintenance tasks and
schedule and update the Preventive Maintenance requirements into the
Preventive Maintenance Master Plan.
6.3 Ongoing Administration of Preventive Maintenance Program
6.3.1 The Engineering Manager shall plan the preventive maintenance schedule.
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 CSH Pharmaceuticals (Pvt.) Ltd. Lahore
SOP NO. ENG/GEN-001/01
6.3.2 The Engineering Manager shall review the preventive maintenance program
based on the evaluation of equipment condition and history, recommendations to
reliability improvement (or continuous improvement), root cause failure
analyses, failure modes and effects analyses, contamination elimination studies,
etc. and adoption of maintenance best practices.
6.4 Record of Maintenance
6.4.1 At the end of the month the respective officer /In-charge will updated the
preventive maintenance schedule.
6.4.2 Daily routine checking will be done and to be recorded in daily log book.
6.4.3 Job operative cards (see relevant SOP for equipment) will be filled for monthly,
quarterly, biannually, & annual maintenance.
6.4.4 Maintenance of machine also to be recorded on history cards (Appendix-5) as
well as job description (Appendix-6) (preventive/break down maintenance or
part change).
6.5 Changing of Preventive Maintenance Tasks/Schedule
Changes to Preventive Maintenance tasks or schedule must be managed as
planned change through change control procedure (QA-019).
6.6 Redundant Equipment
6.6.1 Any equipment that is out of service or no longer in use, for some reasons will
be deactivated from Preventive Maintenance schedule and managed as a planned
change. This will be done through change control (QA-019).
6.6.2 All spares associated to the deactivated equipment shall be reviewed for removal
from the inventory (unless associated spares are common to other active
equipment).
6.6.3 All equipment information and maintenance records (e.g. failure reports,
inspection, service or calibration records) shall be maintained according to the
document retention schedule Ref. SOP No. QA-050
6.7 Criticality Assessment (Direct/Indirect/No Impact)
6.7.1 Direct Impact:

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 CSH Pharmaceuticals (Pvt.) Ltd. Lahore
SOP NO. ENG/GEN-001/01
Classification as direct impact should consider if the machine or system is
involved in manufacturing or packaging of products. These equipment/systems
have components that come into product contact. These also include the clean-
in-place systems for the GMP operations. These are subject to stringent
qualification testing and subsequent change control operations are carried out to
ensure that these systems are always operated in a compliant state. Examples of
such systems are suspension, compression and capsule filling etc.
6.7.2 Indirect Impact:
Indirect impact equipment, machine/systems do not have a direct impact on
product quality, but typically will support a ‘direct impact’ system. These
systems can heavily influence the operation of a direct impact system and hence
compliance during maintenance is also important for example; HVAC system,
Hot Water System, Compressed Air System etc.

6.7.3 No Impact:
Equipment, machine or systems which neither has direct impact or indirect
impact on product quality, e.g. Lifts, ladders and trolley etc.
6.8 Preventive Maintenance Plan Review
Engineering management must reviews the Preventive Maintenance plan periodically to
confirm that contents are still effecting the frequency must be based on an assessment of
the risk to product quality and must not be greater than 3 years. Such reviews must be
documented.
Note:-
All planned activities must be conducted within 30 days of scheduled date month. If
delayed Engineering Manager will discuss the matter in monthly quality forum meeting.
6.9 If we change the part of machine / equipment or install a new one change control
document will be raised as described below:
6.10

Change
Spare parts and Components for plant and facilities fall into four categories
control
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 CSH Pharmaceuticals (Pvt.) Ltd. Lahore
SOP NO. ENG/GEN-001/01
Identical Spare parts having the same specification, same manufacturer, and the
NA
same part number or manufacturers identification as the original
Equivalent Spare parts complying with the same specification and performing the
same function as the original but not necessarily from the same NA
manufacturer.
Replacemen Spare parts that have a different specification but perform the same
Required
t function as the original part.
Redesign Spare parts having a different specification and different functionality
Required
to the original
New If any new equipment installed / facilities change
Required
Equipment

7. VERSION HISTORY:
This SOP, Supersedes the SOP No. ENG-015/02 with following changes:
 SOP allotted new Number and category, ENG/GEN-001/01
 Change Control description is added in procedure.
 Maintenance Schedule – Utility Equipments is added in procedure.
 Changed Appendix No. of Job Description Card
 Note is included in procedure.
 Responsibility of Quality Assurance is defined in procedure .
8. REFERENCES
Guidance for the preparation of Standard Operating Procedures, U.S EPA Current
Version

9. LIST OF APPENDICES:
Appendix-1 Preventive Maintenance Schedule—Electrical
Appendix-2 Preventive Maintenance Schedule—Production Machines
Appendix-3 Preventive Maintenance Schedule—HVAC
Appendix-4 Preventive Maintenance Schedule—Utility Equipments
Appendix-5 Preventive Maintenance Schedule—Civil

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 CSH Pharmaceuticals (Pvt.) Ltd. Lahore
SOP NO. ENG/GEN-001/01

Electrical Preventive maintenance Schedule

Engineering Department YEAR _____________ Appendix-1

MONTH / WEEK
SR AREA / OCT NOV DEC REMARK
JAN FEB MAR APR MAY JUN JULY AUG SEP
No EQUIPMENTS S
1 2 3 4 1 2 3 4 1 2 3 4 1 2 3 4 1 2 3 4 1 2 3 4 1 2 3 4 1 2 3 4 1 2 3 4 1 2 3 4 1 2 3 4 1 2 3 4

750KVA, power
Generator

150KVA, power
Generator

2 LT Panels

Portable
Equipments

3
Insect cutter

Air Curtain
Earth pit testing
Production
Machine

5 Utility Area
6 Technical Area
Equipments
Emergency
Lights
 CSH Pharmaceuticals (Pvt.) Ltd. Lahore
SOP NO. ENG/GEN-001/01
Prepared By: __________________ Approved by Quality Assurance ____________________ Approved By Engineering Manger: ____________________

Electrical Preventive maintenance Schedule

Appendix-1
S MONTH / WEEK
R AREA / REM
JAN FEB MAR APR MAY JUN JULY AUG SEP OCT NOV DEC
N EQUIPMENTS ARKS
o 1 2 3 4 1 2 3 4 1 2 3 4 1 2 3 4 1 2 3 4 1 2 3 4 1 2 3 4 1 2 3 4 1 2 3 4 1 2 3 4 1 2 3 4 1 2 3 4
1

CC TV Cameras

Fire Alarm System

2 Power supply
Backup (UPS)

Telephone
Exchange and
3 Extension Lines

Door inter
locking /Access
Card system

Air Showers and

4 Hand Dryers

Security Lights

Prepared By: __________________ Approved by Quality Assurance ____________________ Approved By Engineering Manger: ____________________

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 CSH Pharmaceuticals (Pvt.) Ltd. Lahore
SOP NO. ENG/GEN-001/01

Preventive maintenance schedule for Production Machine

Engineering Department YEAR ____________ Appendix-2

MONTH / WEEK
Sr. No. AREA / EQUIPMENTS JAN FEB MAR APR MAY JUN JULY AUG SEP OCT NOV DEC
1 2 3 4 1 2 3 4 1 2 3 4 1 2 3 4 1 2 3 4 1 2 3 4 1 2 3 4 1 2 3 4 1 2 3 4 1 2 3 4 1 2 3 4 1 2 3 4
0.15 Suspension Filling Machine
2 Air Blowing Machine
3 Induction Heat Sealer
4 Labeling Machine
5 Bin Blender
6 Bag Dumping Station
7 Fluidized Bed Dryer
8 Encapsulation Machine
9 Metal Detector
10 Dust Extraction unit
11 Capsule polisher
12 Roller Compactor
13 Tablet Compression Machine
14 Metal Detector
15 Dust extraction unit
16 Tablet Coating Machine
17 Blister packing Machine
18 Strip packing Machine
19 Ribbon Mixer Machine

20 Granulator Machine

21 Packing Belts No.1,2 and 3,

Legend:- - Monthly, Δ - quarterly, - Half yearly, - Yearly

Prepared by _______________________________ Approved By: _______________________________ Approved By: ___________________________

Quality Assurance Manager Engineering Manager

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 CSH Pharmaceuticals (Pvt.) Ltd. Lahore
SOP NO. ENG/GEN-001/01

Civil work Preventive maintenance Schedule

Engineering Department YEAR_____________ Apendex-5

SR JAN FEB MAR APR MAY JUN JULY AUG SEP OCT NOV DEC
AREA / EQUIPMENTS
No 1 2 3 4 1 2 3 4 1 2 3 4 1 2 3 4 1 2 3 4 1 2 3 4 1 2 3 4 1 2 3 4 1 2 3 4 1 2 3 4 1 2 3 4 1 2 3 4

1 Production Area

QC Lab. and all corridors

2 Ware house
Administration Block

3 Utility Areas

4 Canteen / pray hall

5 Workshops

6 Outside Production
Area

Prepared By: __________________ Approved by Quality Assurance ____________________ Approved By Engineering Manger: ____________________

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