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VMP
PROTOCOLS
TESTS
VALIDATION
REPORTS
VALIDATIONVALIDATION
Validation is a documented program that provides high degree of assurance that a specified facility or
operation will consistently produce a given product meeting pre determined specification.
VMP
PROTOCOLS
TESTS
VALIDATION
REPORTS
VALIDATION PLANNINGVALIDATION PLANNING
• Prepare Prepare & & Approve Project BriefApprove Project Brief* Define responsibility for the project* Define project function* Define responsibility for validation* Convene project and validation team
•• Prepare Preliminary Project Design and SpecificationPrepare Preliminary Project Design and Specification* Flow sheets / flow diagrams* Layouts* Broad specifications* Rationale
VMP
PROTOCOLS
TESTS
VALIDATION
REPORTS
VMPVMP
VMP is a summary intention document stating the scope of the validation and outlining the
methods to be used to establish the performance adequacy.
VMP
PROTOCOLS
TESTS
VALIDATION
REPORTS
VALIDATION MASTER PLAN VALIDATION MASTER PLAN CONTENTCONTENT
• Introduction• Objective• Approach • Scope& Justification• Acceptance Criteria• Support programs• Organisation• Schedules• Appendix
VMP
PROTOCOLS
TESTS
VALIDATION
REPORTS
INTRODUCTIONINTRODUCTION
• Synopsis of the project and of individual unit operations
• Flow sheets / flow diagrams as references
VMP
PROTOCOLS
TESTS
VALIDATION
REPORTS
OBJECTIVEOBJECTIVE
• A concise statement of the task to allow complete understanding of the validation.
VMP
PROTOCOLS
TESTS
VALIDATION
REPORTS
APPROACHAPPROACH
• Approach as to how the validation is to beconducted
• Define the documents to be produced andthe formal approval method
VMP
PROTOCOLS
TESTS
VALIDATION
REPORTS
SCOPE & JUSTIFICATIONSCOPE & JUSTIFICATION
• Scope and justification for what is includedand what is excluded from the programme.
* Outline critical item to be tested* Qualification matrix* Outline critical parameter to be evaluated
VMP
PROTOCOLS
TESTS
VALIDATION
REPORTS
ACCEPTANCE CRITERIAACCEPTANCE CRITERIA
• Acceptance criteria stated in general terms.
VMP
PROTOCOLS
TESTS
VALIDATION
REPORTS
SUPPORT PROGRAMMESSUPPORT PROGRAMMES
• Support programmes such as training, calibration,change control procedures must be in placebefore PQ.
VMP
PROTOCOLS
TESTS
VALIDATION
REPORTS
ORGANISATIONORGANISATION
• Define responsibility for validation
• Define organisation and management of thevalidation (responsibility matrix)
• Define the team
VMP
PROTOCOLS
TESTS
VALIDATION
REPORTS
SCHEDULESCHEDULE
• The schedule could list
* Man power* Supplies* Services required* Document preparation* Document handling* Validation test equipment* Support service* Work time scale.
VMP
PROTOCOLS
TESTS
VALIDATION
REPORTS
APPENDIXAPPENDIX
* Glossary* Validation method references* Facility and site plans* Process flow sheets* Equipment layout* People and product flows* Air conditioning zone pressure diagrams.
VMP
PROTOCOLS
TESTS
VALIDATION
REPORTS
FAMILY TREEFAMILY TREE
A family tree is a useful document for showing thehierarcy of areas, services and equipment to be validated and for ensuring that all the validation implications of a
given project have been considered and included as necessary.
VMP
PROTOCOLS
TESTS
VALIDATION
REPORTS
• Design Design QualificationQualification
•• Installation Installation QualificationQualification
•• Operational Operational QualificationQualification
•• PerformancePerformance Qualification
VMP
PROTOCOLS
TESTS
VALIDATION
REPORTS
S C O P ER e q u ir e m e n ts S u m m a r yC - C a l i b r a t i o n r e q u ir e d b e f o r e O p e r a ti o n a l Q u a l i f ic a t i o nD Q - D e s ig n q u a l if ic a t io nI Q - In s t a l l a t io n q u a l i f ic a t i o nO Q - O p e r a ti o n a l q u a l i f ic a t io nP Q - P e rf o r m a n c e q u a l i f ic a t i o n
C D Q I Q O Q P Q
B u ild in gB u i ld in g X X X X
S e rv i c e sH V A C ( C ri t ic a l s y s t e m s ) X X X X XI n d u s t r ia l S t e a m ( N o n - c ri t i c a l ) X X XP u r e S t e a m ( C ri t ic a l) X X X X XP o t a b l e W a t e r ( C r i t ic a l ) X X XP u r i f i e d W a t e r ( C r i t ic a l ) X X X X XD i s t i l le d W a te r ( C ri t ic a l) X X X X XC h i ll e d W a t e r ( N o n - c r i t i c a l ) X X X XG a s e s ( C r i t ic a l ) X X X X XC o m p r e s e d A ir ( P r o d u c t c o n t a c t c r i t i c a l ) X X X X X
E q u ip .A u t o c la v e X X X X XV ia l W a s h e r X X X X XS t e r il i z i n g T u n n e l X X X X XF ill i n g M a c h i n e X X X X XC h e c k W e i g h e r X X X X XG a rm e n t W a s h i n g M a c h in e X X X XL a b e l li n g M a c h i n e X X X X XS e m i - a u t o C a r t o n e r X X X X XL a m i n e r F lo w C a b i n e t s X X X X XB lis t e r P a c k in g M a c h i n e X X X X XL e u t o s B a r C o d e s X X X X XT a b l e t P r e s s in g M a c h i n e X X X X XL a b . E q u i p m e n t X X X X
VMP
PROTOCOLS
TESTS
VALIDATION
REPORTS
C - Calibration required before Operational QualificationDQ - Design qualificationIQ - Installation qualificationOQ - Operational qualificationPQ - Performance qualification
C DQ IQ OQ PQ
ProcessCleaning Areas XCleaning Equipments XCleaning Machine Parts XCleaning Garments XFilling Operation XVial Washing XPlugging XCapping XInspection XTest Methods XPacking X
SystemsBuilding Management System C X X X XFire Protection X X X XComputer System X X X X
PeopleTraining XHealth&Safety XPerformance X
VMP
PROTOCOLS
TESTS
VALIDATION
REPORTS
FAMILY TREE
LAY OUTS
MAIN SERVICESINTERFACE
CHILLED WATERGENERATION
SYSTEM
DRAINAGE
BUILDING
STEAM &CONDENSATE
DOMESTICWATER
SYSTEM
CHILLED WATER
L.P.H.W
H.W.S.
UTILITIESMECHANICAL
D.PRESSUREMONITORING
PRODUCTIONAREA A
H.V.A.CPAC01
STEAM &CONDENSATE
CHILLEDWATER
L.P.H.W
DOMESTICWATER
PIPE SERVICESPPS01
MECHANICALPRODUCTION
AREA A
PRODUCTIONAREA B
PLANTROOMNO 1EXT 1
C.P.MONITORING
PLANTROOM No 2COOLING SY S
H.V.A.CPAC02
STEAM &CONDENSATE
CHILLED WATER
L.P.H.W
DOMESTICWATER
PIPESERVICES
PPS 02
MECHANICALPRODUCTION
AREA B
DIST.BOARD
SMALL PW R &LIGHTING
POWER MCC &MOTORS
FIRE SECURITY
TELEPHONES
COMPUTERS
TANNOV
COMMUNICATIONS
ELECTRICAL PROCESSAREA A
PROCESSAREA B
X BUILDING
VMP
PROTOCOLS
TESTS
VALIDATION
REPORTS
CONCEPT DESIGN Concept
DETAIL DESIGNInitial User Brief
Design Specification
DQDQTENDER
CONTRACT AWARD
Initial Tender Package
Design Qualification Review
Final Tender Package
VMP
PROTOCOLS
TESTS
VALIDATION
REPORTS
Ask relevant Questions• What do you want this for
is the best way of doing thisdo you need to make this
•Where do you want to put this•When do you want this
do you need this•Why do you want this and not a slide
do it this way• How will you pay for this
will you build itwill you find the time
How to How to do DQdo DQ
VMP
PROTOCOLS
TESTS
VALIDATION
REPORTS
GlaxoSmithKlineSSiittee.. FFuunnccttiioonnaall DDeessccrriippttiioonn::
PPrroojjeecctt.. LLooccaattiioonn DDrrgg.. NNoo..SScchheemmaattiicc DDrrgg.. NNoo..
PPrroojjeecctt NNoo.. PPllaanntt NNoo..IItteemm RReeff NNoo.. SSyysstteemm NNoo..
IQ
IInnssttaallllaattiioonn iinnssppeecctteedd aanndd ddeettaaiillss rreeccoorrddeedd bbyy:: SSiiggnn:: DDaattee::
IInnssttaallllaattiioonn ccoommpplliieess wwiitthh ddeessiiggnn:: SSiiggnn:: DDaattee::
CCoommmmeennttss oonn IIQQ\\OOQQ::
DDEECCLLAARRAATTIIOONN::IInnssttaallllaattiioonn aanndd OOppeerraattiioonn IInnssppeecctteedd,, TTeesstteedd aanndd ffoouunndd ttoo bbee ssaattiissffaaccttoorryy SSiiggnn:: DDaattee::
VMP
PROTOCOLS
TESTS
VALIDATION
REPORTS
GlaxoSmithKlineSSiittee.. FFuunnccttiioonnaall DDeessccrriippttiioonn::
PPrroojjeecctt.. LLooccaattiioonn DDrrgg.. NNoo..SScchheemmaattiicc DDrrgg.. NNoo..
PPrroojjeecctt NNoo.. PPllaanntt NNoo..IItteemm RReeff NNoo.. SSyysstteemm NNoo..
OQ
CChheecckkeeddbbyy::
WWiittnneesssseeddbbyy:: DDaattee::
CCoommmmeennttss oonn IIQQ\\OOQQ::
DDEECCLLAARRAATTIIOONN::IInnssttaallllaattiioonn aanndd OOppeerraattiioonn IInnssppeecctteedd,, TTeesstteedd aanndd ffoouunndd ttoo bbee ssaattiissffaaccttoorryy SSiiggnn:: DDaattee::
VMP
PROTOCOLS
TESTS
VALIDATION
REPORTS
SShh ee ee tt RReeff.. NNoo :: IIOOTTCC//MM// RReevv::
GlaxoSmithKlineSSiittee.. FFuunnccttiioonnaall DDeessccrriippttiioonn::
PPrroojjeecctt.. LLooccaattiioonn DDrrgg.. NNoo..SScchheemmaattiicc DDrrgg.. NNoo..
PPrroojjeecctt NNoo.. PPllaanntt NNoo..IItteemm RReeff NNoo.. SSyysstteemm NNoo..
P
QCC hheecckkee dd
bbyy::WWiittnneesssseedd
bbyy:: DDaa tt ee::
CCoommmmeennttss oonn PPQQ\\OOQQ::
DDEECCLLAARRAATTIIOONN::IInnssttaallllaattiioonn aanndd OOppeerraattiioonn IInnssppeecctteedd,, TTeesstteedd aanndd ffoouunndd ttoo bbee ssaattiissffaaccttoorryy SSiigg nn:: DDaattee::
VMP
PROTOCOLS
TESTS
VALIDATION
REPORTS
VMPVMP
VMP is a summary intention document stating the scope of the
validation and outlining the methods to be used to establish the
performance adequacy.
VMP
PROTOCOLS
TESTS
VALIDATION
REPORTS
VMP
PROTOCOLS
TESTS
VALIDATION
REPORTS
