GAMP 5Risk based approach to the GxP computer system validation The leading international source of guidance on computer systems validation and compliance 1 GAMP 5 - Good Automated Manufacturing Practices Aurobindo Pharma GAMP History First draft - Feb, 1994 - Distributed UK industry for comments Second draft - Jan, 1995 - Incorporating comments from 31 companies Version 1.0 - Mar, 1995 - Electronic Version only Version 2.0 - May, 1996 - incorporating comments form Europe and USA Version 3.0 - Mar, 1998 - Separation in to User and Supplier Version 4.0 - Dec, 2001 - Major Revision Version 5.0 - Feb, 2008 - Risk based approach to GxP regulated computer systems GAMP4 is 7 years old 2 GAMP 5 - Good Automated Manufacturing Practices Aurobindo Pharma Introduction GAMP has been a part of ISPE for a decade GAMP is leading Community Of Practice (COP) GAMP is Part of bigger ISPE Body of Knowledge Acceptance of GAMP Guidance by regulators worldwide 3 GAMP 5 - Good Automated Manufacturing Practices Aurobindo Pharma Objective To achieve computerized systems that are fit for intended use and meet current regulatory requirements, by building upon existing industry goes practice in an efficient and effective manner 4 GAMP 5 - Good Automated Manufacturing Practices Aurobindo Pharma Objective is on Patient Safety Product Quality Data Integrity 5 GAMP 5 - Good Automated Manufacturing Practices Aurobindo Pharma Scope All GxP Computerized Systems Operational Guidance for IT Labs Manufacturing 6 GAMP 5 - Good Automated Manufacturing Practices Aurobindo Pharma GAMP Document Structure 7 GAMP 5 - Good Automated Manufacturing Practices Aurobindo Pharma 8 GAMP 5 - Good Automated Manufacturing Practices Aurobindo Pharma Management Appendices Appendix M1 Validation Planning Appendix M2 Supplier Assessment Appendix M3 Science Based Quality Risk Management Appendix M4 Categories Of Software and Hardware Appendix M5 Design Review and Traceability Appendix M6 Supplier Quality and Project Planning Appendix M7 Validation Reporting Appendix M8 Project Change and Configuration Mgmt. Appendix M9 Document Management Appendix M10 System Retirement 9 GAMP 5 - Good Automated Manufacturing Practices Aurobindo Pharma Development Appendices Appendix D1 User Requirement Specifications Appendix D2 Functional Specifications Appendix D3 Configuration and Design Appendix D4 Management, Development, and Review of Software Appendix D5 Testing of Computerized Systems Appendix D6 System Descriptions Appendix D7 Data Migration 10 GAMP 5 - Good Automated Manufacturing Practices Aurobindo Pharma Operation Appendices Appendix O1 Handover Appendix O2 Establishing and managing support services Appendix O3 Performance Monitoring Appendix O4 Incident Management Appendix O5 Corrective and Preventive Action Appendix O6 Operational Change and Configuration Management Appendix O7 Repair activity Appendix O8 Periodic Review Appendix O9 Backup and Restore 11 GAMP 5 - Good Automated Manufacturing Practices Aurobindo Pharma Operation Appendices Appendix O1 Business Continuity Management Appendix O11 Functional Specifications Appendix O12 Configuration And Design Appendix O13 Archiving and Retrieval 12 GAMP 5 - Good Automated Manufacturing Practices Aurobindo Pharma Special Interest Topics Appendices Appendix S1 Alignment with ASTM E2500 Appendix S2 Electronic Production Records(EPR) Appendix S3 End User Applications Including Spreadsheets Appendix S4 Managing Quality within an Outsourced IS/IT Environment Appendix S5 Organizational Change 13 GAMP 5 - Good Automated Manufacturing Practices Aurobindo Pharma General Appendices Appendix G1 GAMP Good Practices Guide Summary Appendix G2 Glossary and Acronyms Appendix G3 References 14 GAMP 5 - Good Automated Manufacturing Practices Aurobindo Pharma GAMP 5 Categories Five Categories defined by GAMP Analyze and categorize software and hardware components of a system Used with Risk Assessment Supplier Assessment To determine a suitable life cycle strategy 15 GAMP 5 - Good Automated Manufacturing Practices Aurobindo Pharma GAMP Categories Category GAMP4 GAMP5 1 Operating System Infrastructure software 2 Firmware No longer used 3 Standard software Non-configured packages products 4 Configurable Configured products software packages 5 Custom (bespoke) Custom applications software 16 GAMP 5 - Good Automated Manufacturing Practices Aurobindo Pharma Category 1 –Infrastructure software Operating System and Associated system software Commercially available layered software Infrastructure software tools 17 GAMP 5 - Good Automated Manufacturing Practices Aurobindo Pharma Category 3 –Non-configured Products Non-configurable Default configuration used Simplified life cycle, e.g URS Single test phase 18 GAMP 5 - Good Automated Manufacturing Practices Aurobindo Pharma Category 3 –Example 19 GAMP 5 - Good Automated Manufacturing Practices Aurobindo Pharma Category 4 –Configured Products Standard interfaces and functions Configuration for user specific processes Verify … Requirements Functionality Configuration 20 GAMP 5 - Good Automated Manufacturing Practices Aurobindo Pharma Category 4 –Example 21 GAMP 5 - Good Automated Manufacturing Practices Aurobindo Pharma Category 5 –Custom Applications Meet Specific Needs Comprehensive life cycle e.g.. URS FS Design /Config. Spec Several Levels of Testing 22 GAMP 5 - Good Automated Manufacturing Practices Aurobindo Pharma Category 5 –Example 23 GAMP 5 - Good Automated Manufacturing Practices Aurobindo Pharma Hardware Categories Hardware Category 1 -Standard Document details and verification of installation and connection Hardware Category 2 - Custom Design and acceptance testing Supplier Audit may be required 24 GAMP 5 - Good Automated Manufacturing Practices Aurobindo Pharma Category 5 –Custom Applications Meet Specific Needs Comprehensive life cycle e.g.. URS FS Design /Configuration Spec Several Levels of Testing 25 GAMP 5 - Good Automated Manufacturing Practices Aurobindo Pharma GAMP 5 Key Concepts Five key concepts, based on current and innovative industry thinking underpin the rest of the document Life Cycle approach within a QMS Scalable Life Cycle Activities Process and Product Understanding Science-Based Quality Risk Management Leveraging Supplier Involvement 26 GAMP 5 - Good Automated Manufacturing Practices Aurobindo Pharma GAMP 5 Key Concepts 27 GAMP 5 - Good Automated Manufacturing Practices Aurobindo Pharma Process and Product Understanding Basis of Science-and risk based decisions Focus on critical aspects Identity Specify Verify CQAs/CPPs (Crital Quality Attributes, Critical Process Parameters) 28 GAMP 5 - Good Automated Manufacturing Practices Aurobindo Pharma Life cycle Approach within a QMS Suitable Life Cycle Intrinsic to QMS Continuous improvement 29 GAMP 5 - Good Automated Manufacturing Practices Aurobindo Pharma Life cycle Approach within a QMS A life cycle approach entails defining and performing activates in a systematic way from conception, understanding the requirements, through development, release, and operational use, to system retirement 30 GAMP 5 - Good Automated Manufacturing Practices Aurobindo Pharma 31 GAMP 5 - Good Automated Manufacturing Practices Aurobindo Pharma Scalability Life Cycle Activities Scalability is based on… Risk Complexity Supplier 32 GAMP 5 - Good Automated Manufacturing Practices Aurobindo Pharma Stages within the Project Phase Planning Specification, configuration, and coding verification Reporting and release GAMP 5 - Good Automated Manufacturing 33 Practices Aurobindo Pharma Specification and Verification ASTM E2500 Standard Guide for specification, design, and verification of pharmaceutical and biopharmaceutical Manufacturing Systems and Equipment 34 GAMP 5 - Good Automated Manufacturing Practices Aurobindo Pharma Specification and Verification 35 Aurobindo Pharma GAMP 5 - Good Automated Manufacturing Practices Computer system Validation Framework 36 GAMP 5 - Good Automated Manufacturing Practices Aurobindo Pharma Planning Activities Responsibilities Procedures Timelines 37 GAMP 5 - Good Automated Manufacturing Practices Aurobindo Pharma Reporting and Releasing • Handover Project Team Process Owner System Owner SMEs 38 Operational user Aurobindo Pharma GAMP 5 - Good Automated Manufacturing Practices Science Based Quality Risk Management Assessment Control Communication Review Focus on Patient safety Product quality And data integrity 39 GAMP 5 - Good Automated Manufacturing Practices Aurobindo Pharma 40 GAMP 5 - Good Automated Manufacturing Practices Aurobindo Pharma