vmp is a summary intention document stating the scope of
TRANSCRIPT
VMP
VMP is a summary intention document stating the scope of the validation and outlining the
methods to be used to establish the performance
adequacy.
VALIDATION MASTER PLAN CONTENT
❚ Introduction❚ Objective❚ Approach ❚ Scope& Justification❚ Acceptance Criteria❚ Support programs❚ Organisation❚ Schedules❚ Appendix
INTRODUCTION
❚ Synopsis of the project and of individual unit operations
❚ Flow sheets / flow diagrams as references
OBJECTIVE
❚ A concise statement of the task to allow complete understanding of the validation.
APPROACH
❚ Approach as to how the validation is to beconducted
❚ Define the documents to be produced andthe formal approval method
SCOPE & 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
ACCEPTANCE CRITERIA
❚ Acceptance criteria stated in general terms.
SUPPORT PROGRAMMES
❚ Support programmes such as training, calibration,change control procedures must be in placebefore PQ.
ORGANISATION
❚ Define responsibility for validation
❚ Define organisation and management of thevalidation (responsibility matrix)
❚ Define the team
SCHEDULE
❚ The schedule could list
* Man power* Supplies* Services required* Document preparation* Document handling* Validation test equipment* Support service* Work time scale.
APPENDIX
* Glossary* Validation method references* Facility site plans* Process flow sheets* Equipment layout* People and product flow* Air conditioning zone program diagram* etc.
VALIDATION PLANNING
❚ Prepare & Approve Project Brief* Define responsibility for the project* Define project function* Define responsibility for validation* Convene project and validation team
❚ Prepare Preliminary Project Design and Specification* Flow sheets / flow diagrams* Layouts* Broad specifications* Rationale
FAMILY 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.
❚ Design Qualification
❚ Installation Qualification
❚ Operational Qualification
❚ Performance Qualification
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
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
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
CONCEPT DESIGN Concept
DETAİL DESIGNInitial User Brief
Design Specification
DQDQTENDER
CONTRACT AWARD
Initial Tender Package
Design Qualification Review
Final Tender Package
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 thisWhen do you want this
do you need thisWhy do you want this and not a slide
do it this wayHow will you pay for this
will you build itwill you find the time
How to do DQ
GlaxoSmithKlineSSiittee.. FFuunnccttiioonnaall DDeessccrriippttiioonn::PPrroojjeecctt.. LLooccaattiioonn DDrrgg.. NNoo..
SScchheemmaattiicc DDrrgg.. NNoo..PPrroojjeecctt NNoo.. PPllaanntt NNoo..IItteemm RReeff NNoo.. SSyysstteemm NNoo..
I Q
IInnssttaallllaattiioonn iinnssppeecctteedd aanndd ddeettaaiillss rreeccoorrddeedd bbyy:: SSiiggnn:: DDaattee::
IInnssttaallllaattiioonn ccoommpplliieess wwiitthh ddeessiiggnn:: SSiiggnn:: DDaattee::
CC oomm mm eenntt ss oonn IIQQ \\OO QQ ::
DDEECCLLAARRAATTIIOONN::IInnssttaallllaattiioonn aanndd OOppeerraattiioonn IInnssppeecctteedd,, TTeesstteedd aanndd ffoouunndd ttoo bbee ssaattiissffaaccttoorryy SSiiggnn:: DDaattee::
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::
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::