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

2  You are the Key to Quality  Our aims for today YYYYou are the Key to Quality OOur aims for today Its simple really……….. 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 YYYYou are the Key to Quality OOur aims for today When you leave here today, you will know…. 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, I will expect …… When you leave today, I will 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 YYYYou are the Key to Quality OOur aims for today Where does contamination come from ? Where does contamination come from ? Pests Carried in the air Carried on, or, in other materials Carried on people

6 OFFICES You are the Key to Quality   The Way in & Out!  Y YY You are the Key to Quality  TTTThe Way in & Out!

7 Sources of contamination

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

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