Pharma Terminology

Pharmaceutical Solutions Update Craig Stobie Global Pharmaceutical Business Manager Athens 5 th December 2007

Agenda ,[object Object],[object Object],[object Object],[object Object],[object Object]

Components Overview ,[object Object],[object Object],[object Object],Project Management Coding Vision Mechanical Handling Data Management These hardware or device items are ALWAYS within the factory walls These project aspects MAY be within the factory walls

Components Overview ,[object Object],Project Management Coding Vision Mechanical Handling Data Management These are required for any authentication system External Authentication Server / Database Point of exit / consumer Data Capture and Transmission

Overview ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

Authentication / Mass Serialisation ,[object Object],Pharmacy Manufacturer Carton 1234 Distribution Chain Carton 1234

Security / Layering ,[object Object],Pharmacy Manufacturer Carton 1234 Distribution Chain Carton 1234 Covert Code ABC Covert Code ABC

Aggregation ,[object Object],Manufacturer Carton 1234 Pallet K6J7 Case ABCD These details are all linked

(E) Pedigree (Provenance) ,[object Object],[object Object],[object Object],Pharmacy Manufacturer Wholesaler A Wholesaler B Shipment JHKL Shipment JHKL Shipment JHKL Shipment JHKL

Track and Trace ,[object Object],Pharmacy Manufacturer Wholesaler A Wholesaler B Shipment JHKL Shipment JHKL Shipment JHKL Shipment JHKL Database

Overview ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

Mass Serialisation (at Line) ,[object Object],Carton 352A Carton 583D Carton 483P Carton 197E Coding Device This is requires Hardware, good product handling and Software Line Control Middlewear

Activation / Data Capture ,[object Object],Carton 352A Carton 583D Carton 483P Carton 197E This is requires Hardware, good product handling and Software Vision Device Line Control Middlewear

Middleware and Enterprise ,[object Object],This is requires Software and hardware required to enable the software components Packing Item Database Enterprise Software Line Controllers Middlewear

External Authentication ,[object Object],Point of Exit / Authentication AUTHENTICATION SERVER Point of Entry / Assignation This requires hardware and software to manage the application and capture of the data on the production line the management of the data and Authentication at point of exit

Security Layers ,[object Object],[object Object],[object Object],[object Object]

Overt ,[object Object],[object Object],[object Object]

Covert ,[object Object],[object Object],[object Object]

Forensic ,[object Object],[object Object],[object Object],[object Object],[object Object]

Federation Concept for Authentication FEDERATION SERVER Pharmacy Hospital Hospital Pharmacy Pharmacy

Federation Concept – PILLS Server Diagram Secure Link Secure Link Retail Pharmacy Manufacturer National Govt. Regulatory Authority Secure Link GLN PILLS Server WEB Based Solution Routes all approved participants Logistics & Distribution Manufacturer

[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],EFPIA – Looked at other Globally Successful Structures

Complexity of Requirements Amount of Data Complexity of Solution Italian Decree IFAH CIP EFPIA Track and Trace E Pedigree

When? 2011 2008 2009 2010 IFAH CIP EFPIA Italian Decree Spanish and Portuguese Decrees Pedigree

Thank you for your attention Any Questions?

Pharma Terminology

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