Risk Management Change and Configuration Management Design Review Traceability Document Management Specifications allow – Development – Verification – Maintenance.Specification, configuration, and coding Īctivities Responsibilities Procedures Timelines See Appendix M1.Policies and procedures Roles and responsibilities Training Supplier relationships System inventory Planning for compliance & validation Continuous improvement

The Specification, Design, and Verification Process – Diagram from ASTM E2500 Process Knowledge Regulatory Requirements Company Quality Regs. GAMP5 and ASTM E2500 Good Engineering Practice Product Knowledge Assess: – Suitability – Accuracy – CompletenessĬompatibility with Other Standards ASTM E2500 Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment.Science Based Quality Risk Management AssessmentĬommunication Focus on patient safety, product quality, and data integrity… Focus on critical aspects – Identify – Specify – Verifyįigure 3.3: A General Approach for Achieving Compliance and Fitness for Intended Use Figure xx: A Basic Framework For Achieving Compliance and Fitness For Intended Use Source Figure 3.3, GAMP 5 A Risk Based Approach to Compliance GxP Computerized Systems © Copyright ISPE 2008.Basis of science- and risk-based decisions.Life Cycle Approach Within a QMS Scaleable Life Cycle Activities Process and Product Understanding Science-Based Quality Risk Management Leveraging Supplier Involvement Key Concepts Life Cycle Quality Risk Management Regulated Company Activities Supplier Activities Efficiency Improvements 11 Patient safety product quality data integrity 9 Applied with expertise and good judgementĬalibration Legacy Systems Laboratory VPCS ERES Testing Data Archiving Global Information Systems IT InfrastructureĪvoid duplication Leverage suppliers Scale activities Reflect today – Configurable packages – Development models 8.– Pragmatic guidance – Approaches – Tools for the practitioner It is not a prescriptive method or a standard, but.GAMP Objectives GAMP® guidance aims to achieve computerized systems that are fit for intended use and meet current regulatory requirements, by building upon existing industry good practice in an efficient and effective manner. Consider where GAMP 5 concepts can improve your existing methodology.Get to know the evolution of the GAMP Methodology to the latest release.Resources involved in any way with IT, computer, or automated systems is affected: – Developers – Maintainers – Users.Systems throughout the organization involved in the development, production, storage and distribution of pharmaceutical products or medical devices have to be considered.Overview of Computerized Systems Compliance Using the GAMP® 5 Guide Jim John ProPharma Group, Inc.

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