ISPE_GLChapterSeidelParenteral2010Pres.pptx

GLCHAPTER

1. Company Confidential Copyright © 2000 Eli Lilly and Company Agenda Parenteral Overview Supply Chain Simulation Divide into 4 Groups for Equipment Demos Aseptic Gowning Manufacturing Filling Freeze Dry

2. 2 of 26 Course # MF30629-002 BET ID: 253589 Parenteral Introducing a drug into the body some way other than through the digestive system. Definition

3. Oral Benefit Injectable Less expensive Administrable to nonresponsive patients Patient convenience and comfort Administrable directly to site of action Retrievable, if necessary Better absorption Description Rapid onset of action

4. Indication Product Antipsychotic Zyprexa Diabetes Humulin, Humalog Growth Hormone Humatrope Cancer Gemzar, Alimta Parenteral Products

5. Fegersheim, France Giessen, Germany Sesto, Italy Indianapolis, USA (B103, B105, B107, DDAO) Parenteral Sites

6. Bulk Procurement Form/Fill Finish Affiliate Distribution Wholesaler Retail Consumer Parenteral Manufacturing Supply Chain & Production Planning

7. Air Quality Facilities are divided into 4 grades of air quality: Grade A – Exposed Product Grade B – Adjacent to Product (Operators fully gowned) Grade C – Non- Sterile Production area (Formulation) Grade D – General Corridors A (Exposed Product) B C D Facility

8. Garments Keep the operator from spreading any unwanted contaminants to the product and environment. People Practices

9. Movement disturbs the airflow and stirs up particles. Facility

10. Sterile Filtration Non-Sterile Sterile

11. Filling Line – Traditional Method – Vials Filling

12. Freeze Drying

13. B105 DC Process Flow Company Confidential Copyright © 2000 Eli Lilly and Company August 2010 START END Performed within Grade “A” areas To Packaging Vial Trayoff Vial Inspection Vial Capping Tank CIP Tank SIP Formulation/ Filtration Incoming Raw Materials From Dispensing Incoming Stoppers Stopper Sterilization From Component Warehouse Incoming Vials Vial Wash Vial Depyrogenation Vial Filling, Stoppering

14. INTRODUCTION OF PARENTERAL REPRESENTATIVES