What is GAMP & JETT?

2. What is GAMP & JETT? • Good Automated Manufacturing Practice • ISPE Industry Guidance on Computer System Qualification (Validation) • Joint Equipment Transition Team • Special Interest Group of GAMP • Selected GAMP as “common ground.” • Meet Monthly for review and development.

3. USER Representatives Abbott Labs – Tim Schuetter Pharmacia - Dale Noteboom Eli Lilly - Bret Fisk Aventis Behring – John Dexter Aventis Pasteur – Jeff O’Donel Perrigo – Paul Coury CONSULTANT Reps VAI Automation - Chris Roerig Jacobs Engrg – Brokamp, Buede PV - Mike Filary, Marieva Rivera PAC – Bruce Lauderman Fluor-Daniel – Mike Humphries BE&K Engr – Vince Miller Brock Solutions – John, Casey SUPPLIER Representatives Fisher-Rosemount –Jonathan Lustri Bosch /TL Systems - Terry Petro Vector Corp - Don Rosendale Rockwell – McCarthy, Jiang BOC Edwards –Mike Stella Millipore – Ramon LeDoux Invensys – Russell Regan

4. What is JETT? Mission • Improve communications between Users and Suppliers to more effectively meet the “validation” requirements of the pharmaceutical industry.

5. The Beginning… • Started by Lilly, Pharmacia and Rockwell, June 1996. • Today, 16 active and 28 associate members • Common challenges discussed • Reduced internal resources available • Increased purchases of “packaged” equipment • Common frustration with OEM supplied documentation • Increasing regulatory requirements

6. Validation and Qualification • Design Validation - Did I make the right product and can I prove it? • Process Validation - Does the process consistently produce a result or product meeting predetermined specifications and can I prove it? • Qualification - Action of proving and documenting that equipment or ancillary systems are properly installed, work correctly, and actually lead to the expected results. Qualification is part of validation, but the individual qualification steps alone do not constitute process validation. (Source: FDA’s Current Good Manufacturing Practice)

7. USER REQUIREMENT PERFORMANCE Verifies SPECIFICATION QUALIFICATION FUNCTIONAL OPERATIONAL SPECIFICATION QUALIFICATION Verifies DESIGN INSTALLATION SPECIFICATION QUALIFICATION Verifies SYSTEM BUILD GAMP Qualification Plan A Basic Framework for Specification, Design and Testing GAMP 4.0 Figure 6.2

8. JETT EQUIPMENT ACQUISITION MODEL Functional Specification (traceable to URS) SUPPLIER USER/(CONSULTANT if applicable) Master Validation Plan User Audit Equipment Validation Plan Engineering Feasibility Study and Results P.O. • Explanation to Supplier RFQ User Requirements Specification (Living Document) Proposal • Project Plan • Quality & Validation Plan Proposal P.O. Proposal Analysis Approval Detailed Design Documentation (traceable to Functional Specification) Review Functional Specification Approval System Acceptance Test Specifications (IQ/OQ) Review Detailed Design • Hardware • Software Review System Acceptance Test Specifications Approval System Acceptance Testing and Results User Witness Optional Integrate with Validation Documentation as appropriate Maintenance & Support Documentation

9. JETT Efforts • Applying GAMP to Automated Equipment • Communicating GAMP Approach • Interphex 1997, 2000, 2001, 2002, & 2003 • ISPE - Regional & National Meetings • Pharmaceutical Online Articles • Pharmaceutical Engineering Articles • Institute of Validation Technology – Conferences and Articles • Published in VPCS Supplement to GAMP 4

10. JETT Efforts • Providing Input to GAMP Forum • Developing Guidance for Equipment URS’s, Equipment Validation Plans, Functional and Design Specifications and IQ/OQ’s • Working directly with Industry OEM’s

11. JETT Efforts • Equipment Validation Plan Template • URS Template • Common equipment URS examples and templates • Baseline example for Pure Steam Generator • URS, FRS, HDS, SDS, FAT

12. JETT Efforts • Released URS Documents Vial Washer Barrier Isolator & HVAC System Chromatography Pure Steam Generator Glassware Washers Saturated Steam Autoclave Label Rewinder Labeler Multiple-Effect Still

13. JETT Efforts • URS Documents in development Granulators Tablet Press Variable Data Inspection BioReactors Building Management Systems Centrifuge CIP Systems Fluid Bed Dryer Freeze Dryer Tablet Coater Purified Water System Wide Range Filler Tangential Flow Filtration System SCADA System Cappers Blender Depyrogenation Tunnel

14. Why Do All This? • Good Business Practice • Aligns equipment with application • Delivers equipment in Control, Capable, & Consistently performing as designed • Maintainable • Mandatory by regulatory agencies • FDA = Food & Drug Administration • MCA = Medicines Control Agency

15. How Do I Get Started? • JETT Web Site - www.jettconsortium.com • Meeting Dates, Places and times • Meeting Minutes • JETT Work Products • ContactJETT Members for Assistance • Contact information available on website • Start with Baseline Piece of Equipment • Try out JETT’s URS Template approach on a project requiring a piece of equipment where JETT has a completed template. • Promote with Users, QA, & Suppliers • Integrate in your Standards and Methods • Discuss harmonization of company procedures w/ GAMP with internal validation people