This document provides an introduction to validation, including calibration, qualification, and the difference between calibration and validation. It discusses the scope and purpose of calibration to ensure consistent and accurate measurements. Qualification refers to demonstrating equipment is suitable for its intended use and performs properly, including design, installation, operational, and performance qualification phases. Validation involves systematically determining if facilities, systems, and processes perform as intended. The key difference between calibration and validation is that calibration compares measurements to a reference standard, while validation does not use reference standards. The scope of validation requires appropriate organization, documentation, personnel, and finances.

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