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GAMP/JETT AGENDA l Introduction and GAMP OrganizationDale Noteboom l GAMP Process Control Supplement Jim John l Benefits of the GAMP/JETT Chris Roerig.

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Presentation on theme: "GAMP/JETT AGENDA l Introduction and GAMP OrganizationDale Noteboom l GAMP Process Control Supplement Jim John l Benefits of the GAMP/JETT Chris Roerig."— Presentation transcript:

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2 GAMP/JETT AGENDA l Introduction and GAMP OrganizationDale Noteboom l GAMP Process Control Supplement Jim John l Benefits of the GAMP/JETT Chris Roerig Methodology Methodology l Working SessionJETT Team l Questions & Answers JETT Team

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

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

5 Executive Summary of Good Automated Manufacturing Practice (GAMP) Guide

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

7 GAMP Purpose GAMP Purpose l “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.”

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

9 Part 1: User Responsibilities l Validation (Master) Plan & System Specific Validation Plan(s) – Appendix 6 l Supplier Audit – Appendix 7 l User Requirements Specification – Appendix 5 l Supplier Education

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

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

12 l First Wave –Calibration –IT Infrastructure: Networks, Desktop, –Harmonized Terminology –Electronic Records and Signatures Best Practice Guides

13 l 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 Additional Planned Guides

14 l Third Wave –Legacy Systems –Clinical Systems –Medical Devices –E-Applications: Web-based software –Manufacturing Execution Systems Additional Planned Guides

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

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

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

18 USER Representatives USER Representatives Abbott Labs – Tim Schuetter Abbott Labs – Tim Schuetter Pharmacia - Dale Noteboom Pharmacia - Dale Noteboom Eli Lilly - Bret Fisk Eli Lilly - Bret Fisk Aventis Behring – John Dexter Aventis Behring – John Dexter Aventis Pasteur – Jeff O’Donel Aventis Pasteur – Jeff O’Donel Perrigo – Paul Coury Perrigo – Paul Coury SUPPLIER Representatives SUPPLIER Representatives Fisher-Rosemount – Jon Lustri Fisher-Rosemount – Jon Lustri Bosch /TL Systems - Terry Petro Bosch /TL Systems - Terry Petro Vector Corp - Don Rosendale Vector Corp - Don Rosendale Rockwell – McCarthy, Jiang Rockwell – McCarthy, Jiang BOC Edwards – Mike Stella BOC Edwards – Mike Stella Millipore – Ramon LeDoux Millipore – Ramon LeDoux Invensys – Russell Regan Invensys – Russell Regan JETT MEMBERS CONSULTANT Reps CONSULTANT Reps VAI Automation - Chris Roerig VAI Automation - Chris Roerig Jacobs Engrg – Brokamp, Buede Jacobs Engrg – Brokamp, Buede PV - Filary, Rivera, Lauderman PV - Filary, Rivera, Lauderman PAC – Bruce Lauderman PAC – Bruce Lauderman Fluor-Daniel – Mike Humphries Fluor-Daniel – Mike Humphries BE&K Engr – Vince Miller BE&K Engr – Vince Miller Brock Solutions – John, Casey Brock Solutions – John, Casey ~ 14 Active Members + 45 Assoc. Members & Growing

19 JETT BASELINE EXAMPLE l User Requirement Specification l Project Planning l Functional & Design Specifications l Acceptance Tests - Hardware- System - Software - Factory

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

21 JETT Efforts l Applying GAMP to Automated Equipment l 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

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

23 JETT Efforts l Equipment Validation Plan Template l URS Template l Common equipment URS examples and templates l Baseline example for Pure Steam Generator –URS, FRS, HDS, SDS, FAT

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

25 JETT Efforts l 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

26 GAMP Process Control Supplement

27 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.” “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.”

28 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

29 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

30 GAMP Process Control Supplement - Benefits l 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  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

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

32 JETT Benefits Analysis Chris Roerig

33 Benefits of JETT Approach Provides Standards/Guidelines for  Project Lifecycle  Deliverables  Documentation  Approvals Industry Consistency

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

35 Savings Analysis % of Purchase Price l User5-6 % savings –Gains: l Qualification Protocol development & execution l Life Cycle support (maintenance, upgrades) –Losses: l Additional Auditing l Validation Plan l URS development l Time Savings weeks

36 Savings Analysis % of Purchase Price l Supplier3 - 6% savings –Gains: l Functional, Design, & Test spec development l System production costs l FAT –Losses l Supplier Audits l Time Savings weeks

37 Savings Analysis % of Purchase Price l Consultant % savings –Gains: l Functional, Design, & Test Spec Development l FAT –Losses l Integrator Audits l Time savings 3-10 weeks

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

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

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

41 Post-GAMP Project Requirements Specification Design Qualification Pre-Delivery Inspection Installation Qualification Operational Qualification Software Review Misc. Controls Validation Total Man days (approx.) Efficiency (Day 1) Now Availability (for production) Wastage Maintainability Retrospective Validation Documentation 0 75% 100 Good Unnecessary 0 90% % 100 Engineering Comprehensive - 2 weeks (+ several consultations) days 2 weeks Significant 07 days 5 weeks 0 90 days Performance

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

43 How Do I Get Started? l JETT Web Site – l GAMP Web Site l Contact JETT Members for Help l Start with Baseline Piece of Equip. l Promote with Users, QA, & Suppliers l Integrate in your Stds and Methods

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

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

46 URS Content Checklist Functions required Functions required  Product requirement  Functional requirement  Design requirement Modes of operation Modes of operation Performance and timing Performance and timing Failure actions Failure actions  Hardware  Software

47 URS Content Checklist Safety and security Safety and security Data Data  Archive  Capacity  Speed  Definition of data and valid ranges Interfaces Interfaces Environment Environment

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

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

50 URS Lifecycle l Tools l Training –Engineering –Operations –Maintenance l Support from vendor after: –FAT –Validation complete


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