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Introduction to GMPIntroduction to GMPPart 1Part 1

Contractor TrainingContractor Training31 May 200531 May 2005

Karen RoseKaren RoseQuality ComplianceQuality Compliance

Raising the GMP BarRaising the GMP BarRaising the GMP BarRaising the GMP Bar

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You are the Key to QualityYou are the Key to Quality Our aims for today

You are the Key to QualityYou are the Key to Quality Our aims for today

Its simple really………..Its simple really………..

– We are “Makers of medicines”We are “Makers of medicines”– We supply customers across the worldWe supply customers across the world– Customers have expectationsCustomers have expectations

TimeTime CostCost

QualityQuality

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You are the Key to QualityYou are the Key to Quality Our aims for today

You are the Key to QualityYou are the Key to Quality Our aims for today

When you leave here today ,When you leave here today , you you will know…. will know….

– why we at Novartis care why we at Novartis care – how you should enter and leave the how you should enter and leave the

Production areasProduction areas– what is allowed and what is notwhat is allowed and what is not

When you leave today,When you leave today, II will expect ……will expect ……

– everyone to follow the procedureseveryone to follow the procedures– every manager to ensure their people every manager to ensure their people

follow the procedures follow the procedures – No exceptions ! No exceptions !

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Good Hygiene = Good GMP = Good H & S

Good personal Hygiene prevents accidental exposure to chemicals

Compliance with dress codes further reduces:– Absorption of chemicals– Contamination of personal clothing– Contamination of rest areas and food and

drink

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You are the Key to QualityYou are the Key to Quality Our aims for today

You are the Key to QualityYou are the Key to Quality Our aims for today

Where does contamination come from ?Where does contamination come from ?

PestsPestsCarried in the airCarried in the airCarried on, or, in other materials Carried on, or, in other materials Carried on peopleCarried on people

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OFFICES

You are the Key to QualityYou are the Key to Quality The Way in & Out!The Way in & Out!

You are the Key to QualityYou are the Key to Quality The Way in & Out!The Way in & Out!

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Sources of Sources of contaminationcontamination

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Dress CodeDress Code

OvershoesOvershoes Hat FirstHat First Tyvek SuitTyvek Suit

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Return to GMP area after Return to GMP area after evacuationevacuation

– Remove dirty overshoes and put on Remove dirty overshoes and put on clean a clean pair clean a clean pair

– Change clothingChange clothing

You are the Key to QualityYou are the Key to Quality The Way in & Out!The Way in & Out!

You are the Key to QualityYou are the Key to Quality The Way in & Out!The Way in & Out!