Introduction to validation Qa 2nd sem

1. PRESENTED BY:
EHTESHAM
1422750 (QA)
MMCP
INTRODUCTION TO VALIDATION
PRESENTED
TO:
DR. RINA DAS
MEHTA
MMCP

2. CONTENTS:-
 Calibration
 Qualification
 Validation
 Difference Between calibration and validation
 Scope of Validation

3. CALIBRATION:-
 Calibration of an instrument is the
process of determining its accuracy.
 The process involves obtaining a
reading from the instruments and
measuring its variation from the
reading obtained from a standard
instrument.
 This is important for justifying the
process of qualification and
validation.

4. SCOPE/PURPOSE OF
CALIBRATION:-
To make sure that the reading of
equipment are constistent with
other mesurements and display the
correct reading every time .
To determine
accuracy,precision,reliability, and
deviation of the mesurements
produced by all the instruments.

5. QUALIFICATION:-
It refers to activities undertaken to
demostrate that utilities and
equipments are suitable for their
intended use and perform
properly.
It is the action of proving and
documenting that equipment or
ancillary system are properly
installed,work and actually lead to

6. PHASES OF QUALIFICATION:-
DESIGN QUALIFICATION
INSTALLATION QULIFICATION
OPERATIONAL
QUALIFICATION
PERFORMANCE
QUALIFICATION

7. DESIGN QUALIFICATION(DQ):-
It is the documented verification
that the proposed design of the
facilities,system and equipment
is suitable for the intended use.
DQ should be performed when
new equipment is being
purchased.

8. INSTALLATION
QUALIFICATION(IQ):-
It is documented evidence that
the premises,supporting
utilities,the equipment have
been built and installed in
compliance with design
specification.
It involve the co-ordinate efforts
of the vendor,the operating
department and the project

9. OPERATIONAL
QUALIFICATION(OP):-
It refers to establishing by
objective evidence process
control limits and action levels
which results in product that all
predetermined requirements.
OP is the process of
demonstrating that an instrument
will function according to its
operational specification in the

10. VALIDATION:-
Validation is an integral part of
quality assurance;it involves the
systemic study of
systems,facilities and process
aimed at determining whether
they perform their intended
functions adequately and
consistently as specified.

11. According to Iso:-
 validation is the confirmation
by examination and the
provision of objective evidence
that the particular requirements
for a specific intended use
fulfilled.

12. CALIBRATION VS VALIDATION
CALIBRATION VALIDATION
 Calibration is a
demonstration that,a
particular instrument
or device produces
result within specified
limits by comparisons
with those produced
by a reference
standard over an
appropriate range of
measurements.
 Validation is a
documented
program that
provides high
degree of
assurance that
asystem
consistently
produces a result
meeting pre-
determined

13.  In calibration
performance of
an instruments or
device is
comparing
against a
reference
standard.
 No such
reference
standards are
using in validation
program.

14. SCOPE OF VALIDATION:-
Validation requires an
appropriate and sufficient
infrastructure including :-
organisation,documentation,per
sonnel and finances.
Involvement of management
and quality assurance
personnel.

15. THANK YOU