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Transcript of GAMP/JETT AGENDA l Introduction and GAMP OrganizationDale Noteboom l GAMP Process Control Supplement...
GAMP/JETT AGENDAGAMP/JETT AGENDA
Introduction andIntroduction and GAMPGAMP OrganizationOrganization Dale Dale NoteboomNoteboom
GAMP Process Control Supplement GAMP Process Control Supplement Jim JohnJim John Benefits of the GAMP/JETT Benefits of the GAMP/JETT Chris Chris
RoerigRoerig
MethodologyMethodology Working SessionWorking Session JETT JETT
TeamTeam Questions & AnswersQuestions & Answers JETT JETT
TeamTeam
GAMP Forum DevelopmentsGAMP Forum Developments
~ 12 Special Interest Groups (SIG's)~ 12 Special Interest Groups (SIG's) GAMP Americas established Sept 2000GAMP Americas established Sept 2000
– 8 New Special Interest Groups established8 New Special Interest Groups established New groups incorporated into GAMP New groups incorporated into GAMP
ForumForum– North American JETT Consortium joined North American JETT Consortium joined
(2000)(2000)– UK Suppliers Forum joining (2001)UK Suppliers Forum joining (2001)
GAMP Americas
Namur Group
APV
ISPE/GAMPJETT
Supplier ForumSupplier Forum
GAMP Europe
GAMP Forum Organisation
Executive Summary Executive Summary of of GGood ood AAutomated utomated
MManufacturing anufacturing PPractice (ractice (GAMPGAMP) )
GuideGuide
GAMP Scope: “Automated GAMP Scope: “Automated Systems”Systems” Consist of:Consist of:
– Hardware Hardware - Controlled Functions- Controlled Functions– Software Software - Network Components- Network Components– Associated DocumentationAssociated Documentation
Applies to:Applies to:– Automated Manufacturing EquipmentAutomated Manufacturing Equipment– Control SystemsControl Systems– Automated Laboratory SystemsAutomated Laboratory Systems– Manufacturing Execution SystemsManufacturing Execution Systems– Computers Running Manufacturing or Laboratory DatabasesComputers Running Manufacturing or Laboratory Databases
GAMP PurposeGAMP Purpose
““Help Help supplierssuppliers of automated of automated systems to the pharmaceutical systems to the pharmaceutical industry industry ensureensure that systems that systems are developed following good are developed following good practice and to provide proper practice and to provide proper documentary evidence documentary evidence that that their systems meet the their systems meet the agreed agreed specificationsspecifications.”.”
A Basic Framework for Specification, Design and Testing
GAMP 4.0 Figure 6.2
Verifies
Verifies
Verifies
USER REQUIREMENTUSER REQUIREMENTSPECIFICATION
FUNCTIONALSPECIFICATION
DESIGN SPECIFICATION
SYSTEMBUILD
PERFORMANCEQUALIFICATION
OPERATIONALQUALIFICATION
INSTALLATIONQUALIFICATION
GAMP Qualification GAMP Qualification PlanPlan
Part 1: User Part 1: User ResponsibilitiesResponsibilities
Validation (Master) Plan & Validation (Master) Plan & System Specific Validation System Specific Validation Plan(s)Plan(s)– Appendix 6Appendix 6
Supplier AuditSupplier Audit– Appendix 7Appendix 7
User Requirements SpecificationUser Requirements Specification– Appendix 5Appendix 5
Supplier EducationSupplier Education
Strategic Framework
Quality Management Procedures
Practical Guidance (Good Practice)
Training/Materials Workshop
New Edition: GAMP 4New Edition: GAMP 4
Software categories developed furtherSoftware categories developed further Validation needs to be scaleable Validation needs to be scaleable Global acceptance Global acceptance Examine the balance of work conducted Examine the balance of work conducted
by pharmaceutical manufacturers and by pharmaceutical manufacturers and their suppliers. their suppliers.
Harmonization of terminology with other Harmonization of terminology with other industry forums.industry forums.
GAMP 4 GoalsGAMP 4 Goals
First WaveFirst Wave– CalibrationCalibration– IT Infrastructure: Networks, IT Infrastructure: Networks,
Desktop,Desktop, – Harmonized TerminologyHarmonized Terminology– Electronic Records and SignaturesElectronic Records and Signatures
Best Practice GuidesBest Practice Guides
Second WaveSecond Wave– Control Systems: including Stand-Control Systems: including Stand-
alone PLC/SCADA/DCS and alone PLC/SCADA/DCS and Packaged Systems”/”Skid Mount Packaged Systems”/”Skid Mount Equipment”Equipment”
– Supplier Management Supplier Management – Analytical Laboratory EquipmentAnalytical Laboratory Equipment– Global Systems: ERP, MRPII, LIMS, Global Systems: ERP, MRPII, LIMS,
EDMSEDMS
Additional Planned GuidesAdditional Planned Guides
Third WaveThird Wave– Legacy SystemsLegacy Systems– Clinical SystemsClinical Systems– Medical DevicesMedical Devices– E-Applications: Web-based softwareE-Applications: Web-based software– Manufacturing Execution SystemsManufacturing Execution Systems
Additional Planned GuidesAdditional Planned Guides
GAMP SummaryGAMP Summary
International guideline.International guideline. Good starter system.Good starter system. Continuing to evolve (GAMP4)Continuing to evolve (GAMP4) Basis for Regulatory Agency Basis for Regulatory Agency
Training and expectationsTraining and expectations Good “common ground” for Good “common ground” for
CSV International AlignmentCSV International Alignment
Joint Equipment Joint Equipment Transition TeamTransition Team
(www.JETTconsortium.c(www.JETTconsortium.com)om)
Mission StatementMission Statement
Improve communications Improve communications between Users and Suppliers between Users and Suppliers to more effectively meet the to more effectively meet the “validation” requirements of “validation” requirements of the pharmaceutical industry.the pharmaceutical industry.
USER RepresentativesUSER Representatives• Abbott Labs – Abbott Labs – Tim SchuetterTim Schuetter• Pharmacia - Pharmacia - Dale NoteboomDale Noteboom • Eli Lilly - Eli Lilly - Bret FiskBret Fisk• Aventis Behring – Aventis Behring – John DexterJohn Dexter• Aventis Pasteur – Aventis Pasteur – Jeff O’DonelJeff O’Donel• Perrigo – Perrigo – Paul CouryPaul Coury
SUPPLIER RepresentativesSUPPLIER Representatives• Fisher-Rosemount – Fisher-Rosemount – Jon LustriJon Lustri • Bosch /TL Systems - Bosch /TL Systems - Terry PetroTerry Petro• Vector Corp - Vector Corp - Don RosendaleDon Rosendale• Rockwell – Rockwell – McCarthy, JiangMcCarthy, Jiang • BOC Edwards – BOC Edwards – Mike StellaMike Stella• Millipore – Millipore – Ramon LeDouxRamon LeDoux• Invensys – Invensys – Russell ReganRussell Regan
JETT MEMBERSJETT MEMBERS
CONSULTANT RepsCONSULTANT Reps• VAI Automation - Chris Roerig VAI Automation - Chris Roerig • Jacobs Engrg – Brokamp, BuedeJacobs Engrg – Brokamp, Buede• PV - Filary, Rivera, LaudermanPV - Filary, Rivera, Lauderman• PAC – Bruce LaudermanPAC – Bruce Lauderman• Fluor-Daniel – Mike HumphriesFluor-Daniel – Mike Humphries• BE&K Engr – Vince MillerBE&K Engr – Vince Miller• Brock Solutions – John, CaseyBrock Solutions – John, Casey
~ 14 Active Members~ 14 Active Members
+ 45 Assoc. Members & Growing+ 45 Assoc. Members & Growing
JETT BASELINE EXAMPLE JETT BASELINE EXAMPLE User Requirement SpecificationUser Requirement Specification Project PlanningProject Planning Functional & Design Functional & Design
SpecificationsSpecifications Acceptance TestsAcceptance Tests
- Hardware- Hardware - System- System
- Software - Software - Factory- Factory
Integrate with ValidationDocumentation as appropriate
JETT EQUIPMENT ACQUISITION MODELJETT 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 RequirementsSpecification
(Living Document)
Proposal Analysis
Proposa
lP.O.
Detailed DesignDocumentation
(traceable to Functional Specification)
Review Functional Specification
Review Detailed Design
System Acceptance TestSpecifications (IQ/OQ)
• Hardware • Software
Review SystemAcceptance Test Specifications
System AcceptanceTesting and Results
User Witness Optional
Maintenance & SupportDocumentation
Approval
Approval
Approval
Engineering Feasibility Study and ResultsP.O.
JETT EffortsJETT Efforts
Applying GAMP to Automated Applying GAMP to Automated EquipmentEquipment
Communicating GAMP ApproachCommunicating GAMP Approach– Interphex 1997, 2000, & 2001Interphex 1997, 2000, & 2001– ISPE - Regional & National MeetingsISPE - Regional & National Meetings– Pharmaceutical Online ArticlesPharmaceutical Online Articles– Pharmaceutical Engineering ArticlesPharmaceutical Engineering Articles– Institute of Validation Technology – Institute of Validation Technology –
Conferences and ArticlesConferences and Articles– Published in VPCS Supplement to GAMP 4Published in VPCS Supplement to GAMP 4
JETT EffortsJETT Efforts
Providing Input to GAMP ForumProviding Input to GAMP Forum Developing Guidance for Developing Guidance for
Equipment URS’s, Equipment Equipment URS’s, Equipment Validation Plans, Functional and Validation Plans, Functional and Design Specifications and IQ/OQ’sDesign Specifications and IQ/OQ’s
Working directly with Industry Working directly with Industry OEM’sOEM’s
JETT EffortsJETT Efforts
Equipment Validation Plan TemplateEquipment Validation Plan Template URS TemplateURS Template Common equipment URS examples Common equipment URS examples
and templatesand templates Baseline example for Pure Steam Baseline example for Pure Steam
GeneratorGenerator– URS, FRS, HDS, SDS, FATURS, FRS, HDS, SDS, FAT
JETT EffortsJETT Efforts
Released URS DocumentsReleased URS Documents
Glassware Washers
Saturated Steam Autoclave
Label Rewinder
Labeler
Multiple-Effect Still
Vial Washer
Barrier Isolator & HVAC System
Chromatography
Pure Steam Generator
JETT EffortsJETT Efforts
URS Documents in developmentURS 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
GAMP Process Control GAMP Process Control SupplementSupplement
GAMP Process Control GAMP Process Control Supplement - PurposeSupplement - Purpose
“ “This Guide is intended is a supplement to This Guide is intended is a supplement to the GAMP Guide, and provides a the GAMP Guide, and provides a harmonized overview of the key elements harmonized overview of the key elements involved in the lifecycle of process control involved in the lifecycle of process control systems, from inception to retirement. As systems, from inception to retirement. As such, the Guide complements the current such, the Guide complements the current Baseline Guide on Commissioning and Baseline Guide on Commissioning and Qualification from ISPE.”Qualification from ISPE.”
GAMP Process Control GAMP Process Control Supplement - ScopeSupplement - Scope
Systems that control the manufacturing process, Systems that control the manufacturing process, and have direct impact on product quality and have direct impact on product quality attributes at any stage in the life cycle. Product attributes at any stage in the life cycle. Product quality attributes include the identity, efficacy, quality attributes include the identity, efficacy, strength, dosage, quality, disposition, safety, and strength, dosage, quality, disposition, safety, and purity of the productpurity of the product
Systems that process, transfer, or store process Systems that process, transfer, or store process information in electronic formatinformation in electronic format
GAMP Process Control GAMP Process Control Supplement - BenefitsSupplement - Benefits
Application and adaptation of the general principles of GAMP 4 Application and adaptation of the general principles of GAMP 4 to process control systemsto process control systems
A comprehensive overview of current best practice techniques for A comprehensive overview of current best practice techniques for process control systemsprocess control systems
Reduction of the cost and time required to achieve compliant Reduction of the cost and time required to achieve compliant process control systemsprocess control systems
Application of good practice to the development and Application of good practice to the development and management of projects involving process control systems to management of projects involving process control systems to meet regulatory expectationsmeet regulatory expectations
Harmonized approaches for embedded as well as standalone Harmonized approaches for embedded as well as standalone systemssystems
Detailed definition of engineering stepsDetailed definition of engineering steps
GAMP Process Control GAMP Process Control Supplement - BenefitsSupplement - Benefits
Detailed guidance on the generation of user requirements Detailed guidance on the generation of user requirements specificationsspecifications
Guidance on functionality and structures of process control systems as Guidance on functionality and structures of process control systems as well as supplier services requiredwell as supplier services required
Guidance on the supplier services required for regulated environmentsGuidance on the supplier services required for regulated environmentsAvoids extensive and time-consuming retrospective validation of Avoids extensive and time-consuming retrospective validation of
legacy process control systems, but provides for the application of a legacy process control systems, but provides for the application of a risk based approach, if requiredrisk based approach, if required
Clarifies the collaboration between user and supplierClarifies the collaboration between user and supplierGuidance on incorporation of supplier documentation into the user Guidance on incorporation of supplier documentation into the user
validation documentation Modified and extended supplier audit to validation documentation Modified and extended supplier audit to ensure compliance of the supplier’s development processes and ensure compliance of the supplier’s development processes and documentationdocumentation
GAMP Process Control GAMP Process Control Supplement - ReleaseSupplement - Release
Global Introduction of the VPCS GuideGlobal Introduction of the VPCS Guide
ISPE Washington Continuing Advancement ISPE Washington Continuing Advancement Conference – June 4 Arlington, VAConference – June 4 Arlington, VA
JETT Benefits AnalysisJETT Benefits Analysis
Chris RoerigChris Roerig
Benefits of JETT Benefits of JETT ApproachApproach
Provides Standards/Guidelines forProvides Standards/Guidelines for Project Lifecycle Project Lifecycle DeliverablesDeliverables DocumentationDocumentation ApprovalsApprovals
Industry ConsistencyIndustry Consistency
Benefits of JETT Benefits of JETT ApproachApproach
"Speed to Market" "Speed to Market" Smoother Procurement ProcessSmoother Procurement Process Smoother Validation Process Smoother Validation Process Shorter Project ScheduleShorter Project Schedule
Reduced Project CostsReduced Project Costs Integration Services Integration Services ValidationValidation Re-workRe-work
Savings AnalysisSavings Analysis% of Purchase Price% of Purchase Price
UserUser 5-6 % savings5-6 % savings– Gains:Gains:
Qualification Protocol development & executionQualification Protocol development & execution Life Cycle support (maintenance, upgrades)Life Cycle support (maintenance, upgrades)
– Losses:Losses: Additional AuditingAdditional Auditing Validation Plan Validation Plan URS developmentURS development
Time SavingsTime Savings3 - 14 weeks3 - 14 weeks
Savings AnalysisSavings Analysis% of Purchase Price% of Purchase Price
SupplierSupplier 3 - 6% savings 3 - 6% savings – Gains:Gains:
Functional, Design, & Test spec developmentFunctional, Design, & Test spec development System production costsSystem production costs FAT FAT
– LossesLosses Supplier AuditsSupplier Audits
Time SavingsTime Savings 6 - 8 weeks6 - 8 weeks
Savings AnalysisSavings Analysis% of Purchase Price% of Purchase Price
Consultant Consultant 3 - 4 % savings 3 - 4 % savings – Gains:Gains:
Functional, Design, & Test Spec DevelopmentFunctional, Design, & Test Spec Development FAT FAT
– LossesLosses Integrator Audits Integrator Audits
Time savings Time savings 3-10 weeks3-10 weeks
Real World Real World ExampleExample
Real World Real World ExampleExample
Courtesy of:Courtesy of:Dr. David Selby,Dr. David Selby,
David Begg Associates,David Begg Associates,Kirkbymoorside,Kirkbymoorside,
N. Yorks, UKN. Yorks, UKYO6 6AXYO6 6AX
ScenarioScenario• two equivalent sterile filling linestwo equivalent sterile filling lines• 1991 - ampoules (pre GAMP)1991 - ampoules (pre GAMP)• 1994 - vials (post GAMP)1994 - vials (post GAMP)• equivalent equipment trainequivalent equipment train
- tunnel steriliser- tunnel steriliser- filler- filler- automatic crack detection- automatic crack detection- automatic particulate inspection- automatic particulate inspection
• equivalent project cost (~$2m) equivalent project cost (~$2m)
Engineering
Pre-GAMP Project
RequirementsSpecification Minimal
30 days
Design Qualification
Pre-Delivery Inspection
Installation Qualification
Operational Qualification
Software Review
Misc. ControlsValidation
Total Man days(approx.)
Not done
Not done
Not done
0 100
0 7 days
0 5 weeks
Efficiency(Day 1)
Now
Availability(for production)
Wastage
Maintainability
RetrospectiveValidation
Documentation
Significant
Adequate
0 <30% 100
0 70% 100
Poor
0 60% 100
0 8-12% 100
Performance
Post-GAMP Project
RequirementsSpecification
Design Qualification
Pre-Delivery Inspection
Installation Qualification
Operational Qualification
Software Review
Misc. ControlsValidation
Total Man days(approx.)
Efficiency(Day 1)
Now
Availability(for production)
Wastage
Maintainability
RetrospectiveValidation
Documentation
0 75% 100
Good
Good
Unnecessary
0 90%100
0 100
0 1% 100
EngineeringComprehensive - 2 weeks (+ several consultations)
0 100
4 days
2 weeks
Significant0 7 days
5 weeks0
90 days
Performance
SummarySummary
To derive benefit when validating To derive benefit when validating automated systems :-automated systems :-
• adopt “good engineering practices”• adopt the common approach (GAMP)• manage the benefits through• measure them
postpost GAMPGAMP0 75%
0 90%
0 1%
0 100%
How Do I Get Started?How Do I Get Started?
JETT Web SiteJETT Web Site– www.jettconsortium.comwww.jettconsortium.com
GAMP Web Site GAMP Web Site ContactContact JETT Members for HelpJETT Members for Help Start with Baseline Piece of Equip.Start with Baseline Piece of Equip. Promote with Users, QA, & SuppliersPromote with Users, QA, & Suppliers Integrate in your Stds and Methods Integrate in your Stds and Methods
Working SessionWorking Session
Break into functional groupsBreak into functional groups– QA/ValidationQA/Validation– Manufacturing/OperationsManufacturing/Operations– Environmental/Safety/Utilities/MaintenanceEnvironmental/Safety/Utilities/Maintenance– EngineeringEngineering
Select a piece of OEM equipment (simple)Select a piece of OEM equipment (simple) Develop portions of a URSDevelop portions of a URS Develop portions of project validation planDevelop portions of project validation plan
URS GuidelinesURS Guidelines
Each statement:Each statement:– Uniquely referencedUniquely referenced– Less than 250 wordsLess than 250 words
Express requirements, not design solutionExpress requirements, not design solution Each requirement should be testableEach requirement should be testable URS should be understandable by user and URS should be understandable by user and
suppliersupplier– No ambiguityNo ambiguity– No contradictionsNo contradictions
Distinguish between mandatory and Distinguish between mandatory and desirable items/requirementsdesirable items/requirements
URS Content ChecklistURS Content Checklist
Functions requiredFunctions required Product requirementProduct requirement Functional requirementFunctional requirement Design requirementDesign requirement
Modes of operationModes of operation Performance and timingPerformance and timing Failure actionsFailure actions
HardwareHardware SoftwareSoftware
URS Content ChecklistURS Content Checklist
Safety and securitySafety and security DataData
ArchiveArchiveCapacityCapacitySpeedSpeedDefinition of data and valid rangesDefinition of data and valid ranges
InterfacesInterfaces EnvironmentEnvironment
URS ConstraintsURS Constraints
ScheduleSchedule Compatibility with existing networks, Compatibility with existing networks,
hardware, etc.hardware, etc. Reliability requirementsReliability requirements Legal issues, working methods, user skill Legal issues, working methods, user skill
levels, etc.levels, etc. MaintenanceMaintenance
– Ease of maintenanceEase of maintenance– Expansion capabilityExpansion capability– Expected lifetimeExpected lifetime– Long-term supportLong-term support
URS LifecycleURS Lifecycle
Development – e.g. project Development – e.g. project management/QA/mandatory design management/QA/mandatory design methodsmethods
TestingTesting– Special testing under load conditionsSpecial testing under load conditions– Test dataTest data– SimulationsSimulations
DeliveryDelivery– Shipment directionsShipment directions– Documents – what supplier is expected to Documents – what supplier is expected to
deliverdeliver
URS LifecycleURS Lifecycle
ToolsTools TrainingTraining
– EngineeringEngineering– OperationsOperations– MaintenanceMaintenance
Support from vendor after:Support from vendor after:– FATFAT– Validation completeValidation complete