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

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I Q

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OQ

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PPrroojjeecctt.. LLooccaattiioonn DDrrgg.. NNoo..SScchheemmaattiicc DDrrgg.. NNoo..

PPrroojjeecctt NNoo.. PPllaanntt NNoo..IItteemm RReeff NNoo.. SSyysstteemm NNoo..

P

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