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The document discusses GAMP (Good Automated Manufacturing Practices), an organization that provides guidance for validation of automated systems used in regulated industries. It summarizes GAMP's objectives to achieve compliance through existing industry practices efficiently. It also describes GAMP's structure, including its council, committees, special interest groups and links to regulatory agencies. Finally, it provides an overview of GAMP's guidance documents, principles and validation approaches.
In this document
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Introduction to Good Automated Manufacturing Practices (GAMP) presented by Klaus Krause at ISPE meeting.
Discussion of GAMP’s organizational structure, objectives, and influence on compliance within the industry.
Overview of Special Interest Groups within GAMP focusing on various systems like laboratory and IT.
GAMP's interactions with regulatory bodies like the FDA and how it sets a compliance baseline.
Current and upcoming GAMP Good Practices Guides for various automated systems and processes.
Introduction to GAMP4 guide principles, structured for validating automated systems.
Key themes for validation in automated systems focusing on the system development life cycle.
Categorization of software types in GAMP4 and the stages in the GAMP validation life cycle.
Strategies for system verification, validation management, and planning in GAMP4 compliance.
Guidelines for categorizing systems and assessing supplier capabilities in a validation strategy.
Techniques for identifying risks and conducting validation activities within system development.
Detailed validation approaches for different software categories, including operating systems and custom software.
Validation steps for hardware, including design specifications and verification methodologies.
Defining system specifications and conducting design reviews to ensure compliance and standards.
Practices for software control, testing systems, and maintaining validated operational states.
Recap on GAMP4 emphasizing compliance integration, acknowledgments of contributors and expressing gratitude.
Conclusion of presentation with thanks for interest in GAMP.
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Ispe sf ch_gamp
- 1. 10/7/2004 [email protected] Good AutomatedManufacturing Practices (GAMP) Klaus Krause, Amgen ISPE/GAMP Americas Steering Committee ISPE San Francisco/Bay Area Chapter Meeting, October 7, 2004
- 2. 10/7/2004 [email protected] Presentation Overview I.GAMP - Organization and Objectives II. GAMP4 Guide for Validation of Automated Systems
- 3. 10/7/2004 [email protected] Part 1 GAMPOrganization and Objectives
- 4. 10/7/2004 [email protected] Pivotal Inspection Before AfterValidationPlan Additionally: Specification Design Review (DQ) Source Code Review Supplier Audit IQ OQ PQ Validation Report
- 5. 10/7/2004 [email protected] GAMP Objectives AchieveCompliance by building upon existing industry good practices in an effective and efficient manner
- 6. 10/7/2004 [email protected] GAMP Forum SpecialInterest Groups (SIGs) European Steering Committee Americas Steering Committee GAMP Council Industry Board Local ISPE
- 7. 10/7/2004 [email protected] GAMP Council TechnicalSub-Committee of ISPE Set Directions Influence Industry and Regulators on the Interpretation of Regulations pertaining to: Information Systems Control Systems Laboratory Systems
- 8. 10/7/2004 [email protected] GAMP Organizations GAMPDACH GAMP Americas JETT Supplier ForumSupplier Forum GAMP Europe GAMP Japan
- 9. 10/7/2004 [email protected] Special InterestGroups (SIGs) Laboratory Systems IT Infrastructure Qualification Manufacturing Execution Systems Electronic Data Archiving Global Information Systems Research and Development Systems
- 10. 10/7/2004 [email protected] Special InterestGroups (SIGs) Building Management Systems Testing of GxP Critical Systems JETT Consortium
- 11. 10/7/2004 [email protected] Organizational Links APV(Germany) GMA/NAMUR (Germany) JETT ISPE
- 12. 10/7/2004 [email protected] Links toRegulatory Agencies FDA MCA European Union
- 13. 10/7/2004 [email protected] Influence Established referencein UK/Europe Cited by regulators as baseline practice by regulators (inc. FDA and MCA) Training of FDA Inspectors
- 14. 10/7/2004 [email protected] GAMP GoodPractices Guides GAMP4 Validation of Automated Systems Calibration Management Validation of Process Control Systems Validation of Legacy Systems
- 15. 10/7/2004 [email protected] GAMP GoodPractices Guides In Preparation Validation of Laboratory Systems IT Infrastructure Qualification Validation of Manufacturing Control Systems (MES) Validation of Global Information Systems
- 16. 10/7/2004 [email protected] GAMP GoodPractices Guides In Preparation Validation of R&D Systems Validation of Building Management Systems Testing of GxP Critical Systems Risk based Qualification of Equipment
- 17.
- 18. 10/7/2004 [email protected] Part II GAMP4Guide for Validation of Automated Systems
- 19. 10/7/2004 [email protected] GAMP4 Principles Createsimple, well understood rules Scale validation for size, criticality, and complexity Benefit from supplier capabilities Benefit from configurable SW packages Maintain validated state of the system in the operational environment
- 20. 10/7/2004 [email protected] GAMP4 Principles HarmonizeGAMP terminology with international quality concepts and industry initiatives Collaborate with other industry groups Achieve greater awareness of GAMP internationally
- 21. 10/7/2004 [email protected] Structure ofGAMP4 Guidance GAMP4 Guide is main body Good Practices Guides are supplements to GAMP4 Guide Guidance follows validation life cycle GxP Compliance Solutions for System Users and Suppliers
- 22. 10/7/2004 [email protected] Structure ofGAMP4 Guide GAMP Principles and Framework Appendices Management Development Operation
- 23. 10/7/2004 [email protected] GAMP4 Themes SystemDevelopment Life Cycle Validation Planning Risk and Impact Assessment Supplier Quality Management Specifications Design Review Formal Testing/Verification
- 24. 10/7/2004 [email protected] Automated System Environment:Legal, Organizational, Physical, Technical Documentation Equipment, Instruments Computer Hardware System Software Application SW Data Used together …for a given task
- 25. 10/7/2004 [email protected] GAMP4 SoftwareCategories 1 - Operating Systems 2 - Firmware 3 - Standard Software Packages 4 - Configurable Software Package 5 - Custom Software
- 26. 10/7/2004 [email protected] GAMP4 LifeCycle User Requirements Specifications Performance Qualification Functional Specifications Design Specifications Installation Qualification Operational Qualificationrelated to related to related to System Build
- 27. 10/7/2004 [email protected] System Verification& Validation Sys. Req. System User Requirements Supplier Hardware Software Data 0101 0110 1010 1011 0101 1101 0101 0110 QMS Design Review Audit Report Qualific. Protocol Test Report Verification Protocol Review Protocol = Validation Summary Report
- 28. 10/7/2004 [email protected] Management ofthe Validation Validation Planning Supplier Audit Risk Assessment Categories of Software and Hardware Design Review and Traceability Matrix Quality and Project Planning Document Management Project Change Control Validation Reporting
- 29. 10/7/2004 [email protected] Validation Planning Strategy Deliverables Responsibilities Standardsand Procedures Formally approved Plan
- 30. 10/7/2004 [email protected] System Categorization Manysystems contain software components of more than one category: Operating System Configurable application Firmware Custom modules
- 31. 10/7/2004 [email protected] Supplier Assessment Guidanceand tools on: Assessment of capabilities and product Audits Management
- 32. 10/7/2004 [email protected] User –Supplier Relationship Primary Responsible for TestingPrimary Responsible for Specification System Acceptance Testing (Operational Qualification of Computer/PLC) System Acceptance Testing (Operational Qualification of Computer/PLC) Hardware Acceptance Testing (Installation Qualification of Computer/PLC) Hardware Acceptance Testing (Installation Qualification of Computer/PLC) Functional Specification Hardware Design Specification Testing of the URS Testing of the Functional Specification Testing of the Hardware Specification User Requirements Specification Performance Qualification User User User and Supplier User and Supplier Software Design Specification Software Design Specification Code Modules Code Modules Software Module Specification Software Module Specification Software Module Testing Software Module Testing Software Integration Testing Software Integration Testing Supplier Supplier Review and Test Modules
- 33. 10/7/2004 [email protected] Validation Strategy Basedon: Risk Assessment Assessment and Categorization of System Components Supplier Assessment
- 34. 10/7/2004 [email protected] Risk andImpact Assessment Identify Processes Analyze: Risk scenarios Effects for each event Likelihood of events Severity of Impact Likelihood of Detection Plan for Risk Management
- 35. 10/7/2004 [email protected] Validation Activities PlanningPrepare written Validation Plan. Specification Specify and agree what is required. Perform Design Reviews Prepare document to describe how the equipment or system is to be tested. Test Planning IQ, OQ, PQ Testing IQ, OQ, PQ Perform tests and collect results. ..Review results to show that the system performs as specified, report conclusions plus any reservations Review
- 36. 10/7/2004 [email protected] Validation Approach Category1: Operating System Record version (incl. Service pack) Challenge OS indirectly by the functional
- 37. 10/7/2004 [email protected] Validation Approach Category2: Firmware (Off-the-Shelf) IQ: Verify name, version, configuration, and calibration OQ: Test functionality Change Control for firmware and configuration parameters Supplier Audit for complex or critical applications
- 38. 10/7/2004 [email protected] Validation Approach Category3: Standard Software Packages Configuration limited to the environment and parameters IQ verifies name and version OQ tests user requirements Supplier Audit for critical applications
- 39. 10/7/2004 [email protected] Validation Approach Category4: Configurable Software Packages Treat like Category 5 if platform and package not mature and well-known
- 40. 10/7/2004 [email protected] Validation Approach Category5: Custom Software Execute complete Validation Life Cycle
- 41. 10/7/2004 [email protected] Qualification Approach Category1: Standard Hardware Component Record Model, Version, Serial number of pre- assembled hardware Verify installation and Connections Use hardware data sheet or other specifications for information on sealed units Apply change control and configuration management
- 42. 10/7/2004 [email protected] Qualification Approach Category2: Custom Built Hardware Same as Category 1, plus: Design Specifications with configuration Acceptance Testing Supplier Audit of development process Verification of Compatibility for components from different Sources Verification at IQ
- 43. 10/7/2004 [email protected] System Development BuildSystem and Achieve Validated State User Requirement Specification Functional Specification Hardware Design Specification Software Design Specification Production, Control, and Review of Software Testing of Automated System
- 44. 10/7/2004 [email protected] System Specifications Definethe System Allow further Specifications to be developed Allow the System to be developed Allow Maintenance of the System
- 45. 10/7/2004 [email protected] Design Review(1) Evaluate Deliverables against Standards and requirements Identify problems and propose corrective actions
- 46. 10/7/2004 [email protected] Design Review(2) Are all Requirements addressed? Is functionality appropriate and consistent? Will the system meet predefined standards? Is system appropriately tested?
- 47. 10/7/2004 [email protected] Requirements Traceability Forwardand backward traceability: System Requirements Design Test
- 48. 10/7/2004 [email protected] Traceability Matrix NNText…2.2 YNText…2.1 SATEST3 9.6 DS_DOC1 6.2 FS02 4.2.5NYText…2.0 SATEST3 7.8 DS_DOC1 4.5 FS02 3.1.4YYText…..1.0 TestRef (IQ, OQ, PQ, FAT, SAT) DS RefFS RefOther?GxP?DescriptionURS Ref
- 49. 10/7/2004 [email protected] Software Control ModuleTraceability and Identification Design and Documentation Principles Good Programming Practice Source Code Review
- 50. 10/7/2004 [email protected] Testing ofSystems Test Planning, Specification, Execution, Documentation Scope of Testing Test Specifications Test Deliverables Good Practices for Testing
- 51. 10/7/2004 [email protected] System Operation MaintainValidated State Periodic Review Service Level Agreement Automated System Security Operational Change Control Performance Monitoring Record Retention, Archive, and Retrieval Backup and Recovery of Software and Data Business Continuity Planning
- 52. 10/7/2004 [email protected] GAMP4 Recap GxPComputer Compliance Solutions Integration of Quality Standards (ISO9000) and Industry Standards (IEEE) Consensus of Regulators, Life Science Industry, and Consultants
- 53. 10/7/2004 [email protected] Acknowledgments Dr. DavidSelby, Selby Hope International Sion Wyn, Conformity Arthur Perez, PhD, Novartis
- 54.
- 55. 10/7/2004 [email protected] Thank You foryour Interest in GAMP