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Introduction to GMP Part 1 Contractor Training 31 May 2005 Karen Rose Quality Compliance

Raising the GMP Bar. Introduction to GMP Part 1 Contractor Training 31 May 2005 Karen Rose Quality Compliance. You are the Key to Quality Our aims for today. Its simple really……….. We are “Makers of medicines” We supply customers across the world Customers have expectations Time Cost

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Introduction to GMP Part 1 Contractor Training 31 May 2005 Karen Rose Quality Compliance

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  1. Raising the GMP Bar Introduction to GMP Part 1 Contractor Training 31 May 2005 Karen Rose Quality Compliance

  2. You are the Key to Quality • Our aims for today • Its simple really……….. • We are “Makers of medicines” • We supply customers across the world • Customers have expectations • Time • Cost • Quality

  3. You are the Key to Quality • Our aims for today • When you leave here today , you will know…. • why we at Novartis care • how you should enter and leave the Production areas • what is allowed and what is not • When you leave today,Iwill expect …… • everyone to follow the procedures • every manager to ensure their people follow the procedures • No exceptions !

  4. 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

  5. You are the Key to Quality • Our aims for today • Where does contamination come from ? • Pests • Carried in the air • Carried on, or, in other materials • Carried on people

  6. You are the Key to Quality • The Way in & Out! OFFICES

  7. Sources of contamination

  8. Dress Code • Overshoes • Hat First • Tyvek Suit

  9. You are the Key to Quality • The Way in & Out! • Return to GMP area after evacuation • Remove dirty overshoes and put on clean a clean pair • Change clothing

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