This document discusses preventive maintenance and calibration. It defines preventive maintenance and lists its types. The key benefits are avoiding breakdowns, keeping equipment healthy, and saving costs compared to breakdown maintenance. Calibration ensures instruments are accurate by comparing them to standards. The document outlines the regulatory requirements and the roles and procedures for preventive maintenance and calibration.

1. Presented By- Manoj V.Kumbhar

2.  Defination.
 Types of Maintenance.
 Why we perform the Preventive
maintenance activity.
 Typical responsibilities of engineering.
(maintenance)
 Advantages.

3.  Our practice.
 Calibration.
 Our practice and reasons to perform the
calibration.
 Regulatory awareness.

4. “Actions necessary for retaining or
restoring a piece of equipment,
machine, or system to the specified
operable condition to achieve its
maximum useful life."

5.  Preventive Maintenance
 Predictive Maintenance.
 Breakdown Maintenance.

6. It is a care and servicing by personnel
for the purpose of maintaining
equipment in satisfactory operating
condition by providing for systematic
inspection, detection, and correction.

7. Or in the another words….
Preventative maintenance is performed
while the equipment is still working, so
that it does not break down
unexpectedly.
Or
It is also known as “Periodic
maintenance”.

8. Time based maintenance consists of
periodically inspecting, servicing and
cleaning equipment and replacing parts
to prevent sudden failure and process
problems.

9. It is the techniques, are designed to
help determine the condition of in-
service equipment in order to predict
when maintenance should be performed.

10. Repairs or replacements performed
after a machine has failed to return
to its functional state following a
malfunction or shutdown.

11. What it includes….
Repairs, replacements of spares or even
overhaul to ensure the machine is put
back in operating condition.
But……
in small factories where down
times are non-critical and repair
cost are less than other type of
maintenance.

13. 1.To avoid breakdown time of equipment.
2.To avoid delay in process time.
3.To keep equipment in healthy condition.
4.To avoid the spares cost as compare to
breakdown of machine.
5.It is an schedule based and it’s a cGMP
Practice.

14.  Assure optimization of the
Maintenance Organization structure.
 Analysis of repetitive equipment
failures.
 Estimation of maintenance costs and
evaluation of alternatives.
 Forecasting of spare parts.

15.  Assessing required skills required for
maintenance personnel.
 Ensures that equipment is performing
effectively and efficiently.

16. 1. Enhances the efficiency of equipment
keeping them running more efficiently
also impact on less electrical power
expenses.
2. Enhances the performance of
equipment's by increasing uptime.

17. 3. Extends the useful lifecycle of
equipment's decreasing the need for
capital replacements(i.e.-Spares
inventory).
4. Saves the cost.
5. It saves productive time of the
equipment/ process.

18. 6.It saves labor intensive and time.
7.Reduces cost of replacement.
8. Improved system reliability.

19.  We follow the Standard Operating
Procedure.
 Preparation of Annual Preventive
maintenance Planner.
 Clearance from User department to
carried out the PM activity.
 Execution of PM activity and
completion of documentation.

20. What is Calibration?
Calibration is a comparison between a
known measurement (the standard) and
the measurement using your
instrument.

21.  SOP to be refer to carried out the activity.
 Instruments are categorized as critical and
non-critical.
 For critical instruments the frequency is six
months and for non-critical instruments it is
once in year.
 Annual Planner for calibration to be prepare.

22.  A new instrument.
 After an instrument has been repaired or
modified.
 When a specified time period has elapsed.
 When a specified usage (operating hours) has
elapsed.

23. ICH Q7 guidelines-
 Schedules and procedures should be
established for the preventive maintenance
of equipment.

24.  As per cGMP requirements, schedules
of preventive maintenance for each
equipment in the facility should be
prepared, monitored and documented.
21 CFR part 211 of USFDA-
 211.67 on equipment cleaning and
maintenance.

25.  Frequency of the activity should be
based on criticality w.r.t its impact on
the quality of the product.

26.  Preparation and review of PM schedule-
Engineering.
 Approval of PM schedule- QA
 Execution of PM schedule- Engineering.
 Ensuring availability of equipment for PM-
Concerned owner of equipment.