Date post: | 15-Jul-2015 |
Category: |
Health & Medicine |
Upload: | mohammad-luqman |
View: | 142 times |
Download: | 2 times |
02/11/15 1
Q&VConcept & Terminology
Prepared by: M Luqman Ikram
Assistant Manager Validation
Prepared by: M Luqman Ikram
Assistant Manager Validation
02/11/15 2
Qualification & ValidationQualification & Validation
EquipmentEquipment11
EquipmentEquipment11
SystemSystemAA
SystemSystemAA
EquipmentEquipment22
EquipmentEquipment22
SystemSystemBB
SystemSystemBB
EquipmentEquipment33
EquipmentEquipment33
EquipmentEquipment44
EquipmentEquipment44
Process Process Process Process
Qualificati on
Qualificati onV
alidationV
alidation
Validation
Validation
&&
Qualification is a part of validation
02/11/15 3
Definition:
Action of proving and documenting that the premises,
system & equipment are properly installed, and or work
correctly and lead to expected result.
QualificationQualification
02/11/15 4
Validation
Definition:
Action of proving and documenting
that any process, procedure or
method actually and consistently
leads to the expected results.
02/11/15 5
Validation Project
System Build / Implementation System Build /
Implementation
PlanningPlanningVMP
SpecificationSpecificationURS
FS
VerificationVerification PV/PQ
IQ
OQ
DS/DQ
FAT SAT
ReportingReporting
Summary & Recommendation
Final Report
02/11/15 6
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 adequacyperformance adequacy
QualificationQualification ValidationValidation
Validation Master PlanValidation Master Plan
Process Process ValidationValidation
CleaningCleaning Validation Method Validation
EquipmentEquipmentPremisesPremises Systems/ Utilities
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 Validated List 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)
VMP Format & contents
02/11/15 8
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
Regulatoryrequirement
Migration of any electronic data
CostMaintenance requirement
EH&S requirement
02/11/15 9
functional Specification functional Specification
Definition:
The Functional Specification
describes the detailed operation
of the equipment, from which an
OQ test plan can be constructed.
02/11/15 10
Design Specification 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.
02/11/15 11
Factory Acceptance TestFactory 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.
02/11/15 12
SAT: Site Acceptance Test Equipment testing done at the Final operational site. or Executed with the customer on site.
SITE Acceptance TestSITE Acceptance Test
02/11/15 13
Design QualificationDesign Qualification
Definition:The documented evidence that premises, supporting system, utilities, equipment & process
have been designed in accordance with the requirement of GMP.
02/11/15 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 SpecificationDesign Specification
Verify
Installation QualificationInstallation Qualification
02/11/15 15
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.Q O.Q
Functional SpecificationFunctional SpecificationVerify
Operational QualificationOperational Qualification
02/11/15 16
Process/Performance QualificationProcess/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)
URSURS
Verify
PQPQ
Excellent
Good
Too Much Variation
SpecificationUSL LSL
SpecificationUSL LSL
SpecificationUSL LSL
02/11/15 17
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 Case ScenariosWorst Case Scenarios
02/11/15 18
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.
02/11/15 19
report 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.
02/11/15 20
ProspectiveProspectiveNew Product/process/system/ Equipment
New Product/process/system/ Equipment
Routine Product/Process/system /equipmentConcurrent
Review and analysis of historical DataRetrospective
Repetition of the Qualification/validation process or a specific portion of it. Re-Validation /Qualification
Type of ValidationType of Validation
02/11/15 21
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.
Change control
02/11/15 22
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 Control Change Control
Process Validation
STAGE 02Process
Qualification
STAGE 03Continue process
verification