The document discusses the stages of equipment qualification which include design qualification (DQ), installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ). It states that DQ establishes functional and operational specifications and should be done by the user. While the vendor performs IQ for large, complex instruments, the user performs it for small, low-cost ones. OQ and PQ can be done by either the vendor or user, but PQ should always be done by the user since the applications are specific. The document provides details on the contents and objectives of each qualification stage.

1. 1
Equipment
Validation
Prepared by:
Ms. Navdha Soni
Asst. Professor
L J Institute of Pharmacy

2. Stages of Qualification
DQ
IQ
OQ
PQ

3. Stages of Qualification
Design
Qualification
Installation
Qualification
Operational
Qualification
Performance
Qualification
Change
Control

4. The vendor or the user
q The user has the ultimate
responsibility for the accuracy of the
analysis results and for equipment
qualification.
q DQ should always be done by the
user.
qWhile IQ for a
§ small & low cost instrument is
usually done by the user,
§ large, complex and high cost
instruments should be done by the
vendor.
Who should do Equipment
Validation?

5. qOQ can be done by either the user or
the vendor.
qPQ should always be done by the user
because its application is very specific,
and the vendor may not be familiar
with these. As PQ should be done on a
daily basis, this practically limits this
task to the user.
Who should do Equipment
Validation?

6. Design qualification (DQ)
qDesign qualification (DQ) defines the
functional and operational
specifications of the instrument and
details for the conscious decisions in
the selection of the supplier".
qList of steps that should be considered
for inclusion in a DQ:
ØDescription of the analysis
problem
ØDescription of the intended use of
the equipment
ØDescription of the intended
environment

7. Design qualification (DQ)
ØPreliminary selection of the
functional and performance
specifications
ØPreliminary selection of the
supplier
ØInstrument tests (if the technique is
new)
ØFinal selection of the equipment
ØFinal selection of the supplier and
equipment

8. • “IQ establishes that the instrument is
received as designed & specified, that it is
properly installed in the selected
environment, and this environment is
suitable for the operation & use of the
instrument.”
• Systems and equipment should be
correctly installed in accordance with an
installation plan and installation
qualification protocol.Requirements for
calibration, maintenance and cleaning
should be drawn up during installation.
• Installation qualification should include
identification and verification of all system
elements & parts.
Installation Qualification (IQ)

9. The qualification involves the
coordinated efforts of :
Two functions are remaining after
completion of installation
qualification:
qCalibration
qInstrument Data Sheet Preparation
The
vendor
The
Operating
Department
The Project
Team
QA
Department
Installation Qualification (IQ)

10. Operational Qualification (OQ)
Ø"OQ is the process of demonstrating
that an instrument will function
according to its operational
specification in the selected
environment."
ØThe proper operation of equipment is
verified by performing the test
functions specified in the protocol.
ØTraining of operators for the systems
and equipment should be provided &
training records maintained.

11. Operational Qualification (OQ)
ØSystems & equipment should be
released for routine use after
completion of OQ, provided that all
calibration, cleaning, maintenance,
training & related tests & results were
found to be acceptable.

12. Operational Qualification (OQ)
Following are the contents of equipment
operation qualification
1. Application S.O.P’s
2.Utilization List
3.Process Description
4.Test Instrument Utilized To Conduct Test
5.Test Instrument Calibration
6.Critical Parameters
7.Test Function (List)
8.Test Function Summaries

13. q"PQ is the process of demonstrating
that an instrument consistently
performs according to a specification
appropriate for its routine use ".
qPQ should always be performed under
conditions that are similar to routine
sample analysis
Performance Qualification

14. qThe Validation process is regulated by
the guidelines & restrictions set forth
by the FDA.
qValidation rules are given in the 21
CFR Part 210 & Part 211 as the part of
cGMP. (CFR: Code of Federal
Regulation created by US Government
that sets guidelines pertaining for food
and drugs)
Role of FDA in Validation

15. Questions
1. Which are the installation and
operation qualifications for the
validation of dissolution apparatus?
2. Give in brief about equipment
qualification (EQ).
3. What is EQ? Give the steps of EQ.

16. References
1. P. P. Sharma, “Validation in Pharmaceutical
Industry-concepts, approaches & guidelines”,
1st edition, 2007 Vandana Publication House.
2. B. T. Loftus & R. A. Nash, "Pharmaceutical
Process Validation", Drugs and Pharm Sci.
Series, Vol. 129, 3rd Ed., Marcel Dekker Inc.,
N.Y.
3. Berry I.R., and Nash R.A.,
”Pharmaceutical Process validation”
second edition, revised and expanded;
Marcel Dekker series; 83-110.
4. WHO TRS No.937,2006,pg no.:143-173
5. Agalloco J.A, Carleton F.A, ”Validation of
Pharmaceutical Process, Third Edition,
175,223.

17. Thank you