1. 07 July 2012 1
Q&V
Concept & Terminology
Well Come to Validation
Team & Review Board
Presented by: M Luqman Ikram
2. 07 July 2012 2
Qualification & Validation
EquipmentEquipment
11
SystemSystem
AA
EquipmentEquipment
22
SystemSystem
BB
EquipmentEquipment
33
EquipmentEquipment
44
Process Process
QualificationQualification
ValidationValidation
ValidationValidation&&
Qualification is a part of validation
3. 07 July 2012 3
Qualification
Definition:
Action of proving and documenting that the premises,
system & equipment are properly installed, and or work
correctly and lead to expected result.
4. 07 July 2012 4
Validation
Definition:
Action of proving and documenting that
any process, procedure or method
actually and consistently leads to the
expected results.
5. 07 July 2012 5
Validation Project
System Build /
Implementation
Planning
VMP
SpecificationURS
FS
Verification PV/PQ
IQ
OQ
DS/DQ
FAT SAT
Reporting
Summary &
Recommendation
Final Report
6. 07 July 2012 6
Validation 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
Qualification Validation
Validation Master Plan
Product/Process Product/Process
Cleaning procedure Cleaning procedure
Computer System Computer System
Analytical Analytical Method
EquipmentEquipmentPremisesPremisesSystems/
Utilities
7. 07 July 2012 7
VMP Format & contents
Introduction & Firm's validation policy,
Organizational Structure of All Validation Activities
Plant / Process / Product Description
Specific Process Considerations (Critical Point of process)
List of Products/Processes/ Systems/Equipment to be Validated
Validation Approach (Prospective, concurrent, Retrospective, Revalidation)
Key Acceptance Criteria
Documentation Format
Required SOP's
Planning & Scheduling
Change Control
8. 07 July 2012 8
USER 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:
Functional &
Operational
requirement
Regulatory
requirement
Migration of any
electronic data
Cost
Maintenance
requirement
EH&S
requirement
9. 07 July 2012 9
functional Specification
Definition:
The Functional Specification
describes the detailed operation of
the equipment, from which an OQ
test plan can be constructed.
10. 07 July 2012 10
Design 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.
11. 07 July 2012 11
Factory Acceptance Test
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.
12. 07 July 2012 12
SITE Acceptance Test
SAT: Site Acceptance TestEquipment testing done at
the Final operational site.orExecuted with the customeron site.
13. 07 July 2012 13
Design Qualification
Definition:The documented evidence that
premises, supporting system,
utilities, equipment & process
have been designed in
accordance with the requirementof GMP.
14. 07 July 2012 14
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 Specification
Verify
Installation Qualification
15. 07 July 2012 15
Operational Qualification
Definition:
The documented verification that the system or
subsystem performs as intended over all anticipated
operating ranges.
Verify
Operational QualificationFunctional Specification
Control function Test Operational test
O.Q
16. 07 July 2012 16
Process/Performance Qualification
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)
URS
Verify
PQ
Too Much
Variation
Specification
USL LSL
Good
Specification
USL LSL
Excellent
Specification
USL LSL
17. 07 July 2012 17
Worst Case Scenarios
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)
18. 07 July 2012 18
Protocol
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.
19. 07 July 2012 19
report
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.
20. 07 July 2012 20
Type of Validation
Prospective
New Product/process/system/
Equipment
Routine Product/Process/system /equipment
Concurrent
Review and analysis of historical DataRetrospective
Repetition of the Qualification/validation process or a specific portion of it.
Re‐Validation /Qualification
21. 07 July 2012 21
Change control
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.
22. 07 July 2012 22
Process Validation
STAGE 01
Process Design
STAGE 02
Process
Qualification
STAGE 03
Continue
process
verification
Based on
product
Quality &
patient safety
Know the
process
Know the
Variable
Have the
confidence Vigilance
1. Process
Understanding
2. Process
Design
3. Process
Qualification
4. Commercial
Manufacturing
5. Monitoring
&
Improvement
Change Control
