The document discusses concepts and terminology related to qualification and validation of equipment and systems. It defines qualification as proving that premises, systems and equipment are properly installed and work correctly. Validation is defined as proving that processes, procedures or methods consistently lead to expected results. The document provides definitions and descriptions of key terms in validation including validation master plan, user requirement specification, functional specification, design specification, factory acceptance testing, site acceptance testing, design qualification, installation qualification, operational qualification, process/performance qualification, protocols, reports, and types of validation.

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Q&V
Concept & Terminology
Prepared by: M Luqman Ikram
Assistant Manager
Validation
Prepared by: M Luqman Ikram
Assistant Manager
Validation

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Qualification & ValidationQualification & Validation
EquipmentEquipment
11
EquipmentEquipment
11
SystemSystem
AA
SystemSystem
AA
EquipmentEquipment
22
EquipmentEquipment
22
SystemSystem
BB
SystemSystem
BB
EquipmentEquipment
33
EquipmentEquipment
33
EquipmentEquipment
44
EquipmentEquipment
44
ProcessProcessProcessProcess
QualificationQualification
ValidationValidation
ValidationValidation&&
Qualification is a part of validation

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Definition:
Action of proving and documenting that the premises,
system & equipment are properly installed, and or work
correctly and lead to expected result.
QualificationQualification

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Validation
Definition:
Action of proving and documenting
that any process, procedure or
method actually and consistently
leads to the expected results.

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Validation Project
System Build /
Implementation
System Build /
Implementation
PlanningPlanning
VMP
SpecificationSpecificationURS
FS
VerificationVerification PV/PQ
IQ
OQ
DS/DQ
FAT SAT
ReportingReporting
Summary &
Recommendation
Final Report

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Validation Master PlanValidation Master Plan
Definition
A Validation Master Plan is a
document that summarizes the firm's
overall philosophy, intention and
approach to be used for establishing
performance adequacy
performance adequacy
QualificationQualification ValidationValidation
Validation Master PlanValidation Master Plan
ProcessProcess
ValidationValidation
CleaningCleaning Validation
Method Validation
EquipmentEquipmentPremisesPremisesSystems/
Utilities

7. 02/11/15 7Change ControlChange Control
Planning & SchedulingPlanning & Scheduling
Required SOP'sRequired SOP's
Documentation FormatDocumentation Format
Key Acceptance CriteriaKey Acceptance Criteria
List of Products/Processes/ Systems/Equipment to be ValidatedList of Products/Processes/ Systems/Equipment to be Validated
Validation Approach (Prospective, concurrent, Retrospective, Revalidation)Validation Approach (Prospective, concurrent, Retrospective, Revalidation)
Plant / Process / Product DescriptionPlant / Process / Product Description
Organizational Structure of All Validation ActivitiesOrganizational Structure of All Validation Activities
Introduction & Firm's validation policy,Introduction & Firm's validation policy,
Specific Process Considerations (Critical Point of process)Specific Process Considerations (Critical Point of process)
VMPFormat & contents

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USER required specificationUSER required specification
Definition
A document stating the specified
user requirement for a select piece
of equipment, System or Facility.
The contents of a URS typically include, but are not limited to
the following:
The contents of a URS typically include, but are not limited to
the following:
Functional &
Operational
requirement
Regulatory
requirement
Migration of any
electronic data
Cost
Maintenance
requirement
EH&S
requirement

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functional Specificationfunctional Specification
Definition:
The Functional Specification
describes the detailed operation
of the equipment, from which an
OQ test plan can be constructed.

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Design SpecificationDesign Specification
Definition:
The Design Specification usually
consists of the electrical
schematics, part descriptions, and
the detail required to construct the
system. from which an IQ test plan
can be constructed.

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Factory AcceptanceTestFactory AcceptanceTest
Factory Acceptance Test (FAT):
is a test conducted at the
Vender’s premises, usually by a
third party, to verify that the
System, Equipment operates
according to the specifications.

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SAT: Site Acceptance TestEquipment testing done at
the Final operational site.orExecuted with thecustomer on site.
SITE AcceptanceTestSITE AcceptanceTest

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Design QualificationDesign Qualification
Definition:The documented evidence that
premises, supporting system,
utilities, equipment & process
have been designed inaccordance with therequirement of GMP.

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Installation Qualification
I.Q
Documentation
&Identification
Peripheral
equipments
Utilities Maintenance
&Lubrications
CalibrationTraining
Safety
feature
Evaluation of
Machine
motor
Definition
The performance of test to ensure that the installation
(such as machine, measuring device, utilities,
manufacturing area) used in manufacturing process are
appropriately selected and correctly installed &
operate in accordance with establish specification.
Design SpecificationDesign Specification
Verify
Installation QualificationInstallation Qualification

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Operational QualificationOperational Qualification
Definition:
The documented verification that the system or
subsystem performs as intended over all anticipated
operating ranges.
Control function Test Operational test
O.QO.Q
Functional SpecificationFunctional Specification
Verify
Operational QualificationOperational Qualification

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Process/PerformanceQualificationProcess/PerformanceQualification
Definition
The documented verification that the facilities,
systems and equipment operate consistently and
gives reproducibility within define specification
and parameter for prolong period.
Or
Confirming that the manufacturing process as
designed is capable of reproducible commercial
manufacturing. (FDA)
URSURS
Verify
PQPQ
Excellent
Good
Too Much
Variation
Specification
USL LSL
Specification
USL LSL
Specification
USL LSL

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A condition or set of conditions encompassing upper and
lower processing limits and circumstances, within SOP,
which pose the greatest chance of product or process
failure when compared to ideal conditions. Such
conditions do not necessarily induce product or process
failure.
(e.g. start-up after shutdown, temperature recovery
time, Autoclave largest load, or largest mass)
Worst CaseScenariosWorst CaseScenarios

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ProtocolProtocol
Protocol:
A document that spells out
what tests are to be
performed, how the tests
are to be performed, what
data are to be collected,
and what the accep­
tance criteria are.

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reportreport
Report:
A document in which the records,
results & evaluation of a completed
validation / Qualification programme
are assemble & summarized. it may also
contain proposal for improvement of
process, System and/or Equipment.

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ProspectiveProspective
New Product/process/system/
Equipment
New Product/process/system/
Equipment
Routine Product/Process/system/equipment
Concurrent
Review and analysis of historical DataRetrospective
Repetition of theQualification/validation processor a specific portion of it.
Re-Validation /Qualification
Typeof ValidationTypeof Validation

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A formal system by which qualified
representatives of appropriate
disciplines review proposed or
actual changes that might affect
the validated status of facilities,
systems, equipment or processes.
Changecontrol

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STAGE 01
Process Design
Based on
product
Quality &
patient safety
Know the
process
Know the
Variable
Have the
confidence Vigilance
1. Process
Understanding
1. Process
Understanding
2. Process
Design
2. Process
Design
3. Process
Qualification
3. Process
Qualification
4. Commercial
Manufacturing
4. Commercial
Manufacturing
5. Monitoring &
Improvement
5. Monitoring &
Improvement
Change ControlChange Control
ProcessValidation
STAGE 02
Process
Qualification
STAGE 03
Continue process
verification

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