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GAMP/JETT AGENDA

GAMP/JETT AGENDA. Introduction and GAMP Organization Dale Noteboom GAMP Process Control Supplement Jim John Benefits of the GAMP/JETT Chris Roerig Methodology Working Session JETT Team Questions & Answers JETT Team. GAMP Forum Developments. ~ 12 Special Interest Groups (SIG's)

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GAMP/JETT AGENDA

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  1. GAMP/JETT AGENDA • Introduction andGAMPOrganization Dale Noteboom • GAMP Process Control Supplement Jim John • Benefits of the GAMP/JETT Chris Roerig Methodology • Working Session JETT Team • Questions & AnswersJETT Team

  2. GAMP Forum Developments • ~ 12 Special Interest Groups (SIG's) • GAMP Americas established Sept 2000 • 8 New Special Interest Groups established • New groups incorporated into GAMP Forum • North American JETT Consortium joined (2000) • UK Suppliers Forum joining (2001)

  3. JETT ISPE/GAMP GAMP Forum Organisation APV Namur Group Supplier Forum GAMP Americas GAMP Europe

  4. Executive Summary of Good Automated Manufacturing Practice (GAMP) Guide

  5. GAMP Scope: “Automated Systems” • Consist of: • Hardware - Controlled Functions • Software - Network Components • Associated Documentation • Applies to: • Automated Manufacturing Equipment • Control Systems • Automated Laboratory Systems • Manufacturing Execution Systems • Computers Running Manufacturing or Laboratory Databases

  6. GAMP Purpose • “Help suppliers of automated systems to the pharmaceutical industry ensure that systems are developed following good practice and to provide proper documentary evidence that their systems meet the agreed specifications.”

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

  8. Part 1: User Responsibilities • Validation (Master) Plan & System Specific Validation Plan(s) • Appendix 6 • Supplier Audit • Appendix 7 • User Requirements Specification • Appendix 5 • Supplier Education

  9. New Edition: GAMP 4 Strategic Framework Quality Management Procedures Practical Guidance (Good Practice) Training/Materials Workshop

  10. GAMP 4 Goals • Software categories developed further • Validation needs to be scaleable • Global acceptance • Examine the balance of work conducted by pharmaceutical manufacturers and their suppliers. • Harmonization of terminology with other industry forums.

  11. Best Practice Guides • First Wave • Calibration • IT Infrastructure: Networks, Desktop, • Harmonized Terminology • Electronic Records and Signatures

  12. Additional Planned Guides • Second Wave • Control Systems: including Stand-alone PLC/SCADA/DCS and Packaged Systems”/”Skid Mount Equipment” • Supplier Management • Analytical Laboratory Equipment • Global Systems: ERP, MRPII, LIMS, EDMS

  13. Additional Planned Guides • Third Wave • Legacy Systems • Clinical Systems • Medical Devices • E-Applications: Web-based software • Manufacturing Execution Systems

  14. GAMP Summary • International guideline. • Good starter system. • Continuing to evolve (GAMP4) • Basis for Regulatory Agency Training and expectations • Good “common ground” for CSV International Alignment

  15. Joint Equipment Transition Team(www.JETTconsortium.com)

  16. Mission Statement • Improve communications between Users and Suppliers to more effectively meet the “validation” requirements of the pharmaceutical industry.

  17. JETT MEMBERS 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 SUPPLIER Representatives • Fisher-Rosemount – Jon Lustri • Bosch /TL Systems - Terry Petro • Vector Corp - Don Rosendale • Rockwell – McCarthy, Jiang • BOC Edwards – Mike Stella • Millipore – Ramon LeDoux • Invensys – Russell Regan CONSULTANT Reps • VAI Automation - Chris Roerig • Jacobs Engrg – Brokamp, Buede • PV - Filary, Rivera, Lauderman • PAC – Bruce Lauderman • Fluor-Daniel – Mike Humphries • BE&K Engr – Vince Miller • Brock Solutions – John, Casey ~ 14 Active Members + 45 Assoc. Members & Growing

  18. JETT BASELINE EXAMPLE • User Requirement Specification • Project Planning • Functional & Design Specifications • Acceptance Tests - Hardware - System - Software - Factory

  19. 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

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

  21. 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

  22. 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

  23. 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

  24. 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

  25. GAMP Process Control Supplement

  26. GAMP Process Control Supplement - Purpose “This Guide is intended is a supplement to the GAMP Guide, and provides a harmonized overview of the key elements involved in the lifecycle of process control systems, from inception to retirement. As such, the Guide complements the current Baseline Guide on Commissioning and Qualification from ISPE.”

  27. GAMP Process Control Supplement - Scope • Systems that control the manufacturing process, and have direct impact on product quality attributes at any stage in the life cycle. Product quality attributes include the identity, efficacy, strength, dosage, quality, disposition, safety, and purity of the product · Systems that process, transfer, or store process information in electronic format

  28. GAMP Process Control Supplement - Benefits · Application and adaptation of the general principles of GAMP 4 to process control systems · A comprehensive overview of current best practice techniques for process control systems · Reduction of the cost and time required to achieve compliant process control systems · Application of good practice to the development and management of projects involving process control systems to meet regulatory expectations · Harmonized approaches for embedded as well as standalone systems · Detailed definition of engineering steps

  29. GAMP Process Control Supplement - Benefits • Detailed guidance on the generation of user requirements specifications · Guidance on functionality and structures of process control systems as well as supplier services required · Guidance on the supplier services required for regulated environments · Avoids extensive and time-consuming retrospective validation of legacy process control systems, but provides for the application of a risk based approach, if required · Clarifies the collaboration between user and supplier · Guidance on incorporation of supplier documentation into the user validation documentation Modified and extended supplier audit to ensure compliance of the supplier’s development processes and documentation

  30. GAMP Process Control Supplement - Release Global Introduction of the VPCS Guide ISPE Washington Continuing Advancement Conference – June 4 Arlington, VA

  31. JETT Benefits AnalysisChris Roerig

  32. Benefits of JETT Approach Provides Standards/Guidelines for • Project Lifecycle • Deliverables • Documentation • Approvals Industry Consistency

  33. "Speed to Market" Smoother Procurement Process Smoother Validation Process Shorter Project Schedule Reduced Project Costs Integration Services Validation Re-work Benefits of JETT Approach

  34. Savings Analysis% of Purchase Price • User 5-6 % savings • Gains: • Qualification Protocol development & execution • Life Cycle support (maintenance, upgrades) • Losses: • Additional Auditing • Validation Plan • URS development • Time Savings 3 - 14 weeks

  35. Savings Analysis% of Purchase Price • Supplier 3 - 6% savings • Gains: • Functional, Design, & Test spec development • System production costs • FAT • Losses • Supplier Audits • Time Savings 6 - 8 weeks

  36. Savings Analysis% of Purchase Price • Consultant 3 - 4 % savings • Gains: • Functional, Design, & Test Spec Development • FAT • Losses • Integrator Audits • Time savings 3-10 weeks

  37. Real World Example Courtesy of: Dr. David Selby, David Begg Associates, Kirkbymoorside, N. Yorks, UK YO6 6AX

  38. Scenario • two equivalent sterile filling lines • 1991 - ampoules (pre GAMP) • 1994 - vials (post GAMP) • equivalent equipment train- tunnel steriliser - filler - automatic crack detection - automatic particulate inspection • equivalent project cost (~$2m)

  39. 0 <30% 100 0 60% 100 0 70% 100 0 8-12% 100 Pre-GAMP Project Engineering Performance Requirements Specification Minimal Efficiency (Day 1) Not done Design Qualification Pre-Delivery Inspection Installation Qualification Operational Qualification Software Review 0 7 days Now Availability (for production) Wastage Maintainability Retrospective Validation 5 weeks 0 Not done Poor Misc. Controls Validation Total Man days (approx.) Not done Significant Documentation 0 100 Adequate 30 days

  40. 0 75% 100 0 90%100 5 weeks 0 0 100 0 1% 100 Post-GAMP Project Engineering Performance Comprehensive - 2 weeks (+ several consultations) Requirements Specification Efficiency (Day 1) Significant Design Qualification Pre-Delivery Inspection Installation Qualification Operational Qualification Software Review 0 7 days Now Availability (for production) Wastage Maintainability Retrospective Validation 4 days Good Misc. Controls Validation Total Man days (approx.) Unnecessary Documentation 2 weeks 0 100 Good 90 days

  41. 0 75% • adopt “good engineering practices” • adopt the common approach (GAMP) • manage the benefits through • measure them 0 90% 100% 0 0 1% Summary To derive benefit when validating automated systems :- postGAMP

  42. How Do I Get Started? • JETT Web Site • www.jettconsortium.com • GAMP Web Site • ContactJETT Members for Help • Start with Baseline Piece of Equip. • Promote with Users, QA, & Suppliers • Integrate in your Stds and Methods

  43. Working Session • Break into functional groups • QA/Validation • Manufacturing/Operations • Environmental/Safety/Utilities/Maintenance • Engineering • Select a piece of OEM equipment (simple) • Develop portions of a URS • Develop portions of project validation plan

  44. URS Guidelines • Each statement: • Uniquely referenced • Less than 250 words • Express requirements, not design solution • Each requirement should be testable • URS should be understandable by user and supplier • No ambiguity • No contradictions • Distinguish between mandatory and desirable items/requirements

  45. URS Content Checklist • Functions required • Product requirement • Functional requirement • Design requirement • Modes of operation • Performance and timing • Failure actions • Hardware • Software

  46. URS Content Checklist • Safety and security • Data • Archive • Capacity • Speed • Definition of data and valid ranges • Interfaces • Environment

  47. URS Constraints • Schedule • Compatibility with existing networks, hardware, etc. • Reliability requirements • Legal issues, working methods, user skill levels, etc. • Maintenance • Ease of maintenance • Expansion capability • Expected lifetime • Long-term support

  48. URS Lifecycle • Development – e.g. project management/QA/mandatory design methods • Testing • Special testing under load conditions • Test data • Simulations • Delivery • Shipment directions • Documents – what supplier is expected to deliver

  49. URS Lifecycle • Tools • Training • Engineering • Operations • Maintenance • Support from vendor after: • FAT • Validation complete

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