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Overview of Computerized Systems Compliance Using the GAMP® 5 Guide
- 1. Overview of Computerized SystemsCompliance Using the GAMP® 5 Guide Jim John ProPharma Group, Inc. (816) 682-2642 jim.john@propharmagroup.com
- 2. Who Cares AboutCSV? • Systems throughout the organization involved in the development, production, storage and distribution of pharmaceutical products or medical devices have to be considered • Resources involved in any way with IT, computer, or automated systems is affected: – Developers – Maintainers – Users
- 3. Purpose of ThisPresentation • To discuss and clarify key topics • Get to know the evolution of the GAMP Methodology to the latest release • Consider where GAMP 5 concepts can improve your existing methodology
- 4. GAMP Objectives GAMP® guidanceaims 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. 4
- 5. Guidance • It isnot a prescriptive method or a standard, but.. – Pragmatic guidance – Approaches – Tools for the practitioner • Applied with expertise and good judgement 5
- 6. Evolution of GAMPGuidance 54321 Calibration Legacy Systems Laboratory VPCS ERES Testing Data Archiving Global Information Systems IT Infrastructure
- 7.
- 8. Other Drivers • Avoidduplication • Leverage suppliers • Scale activities • Reflect today – Configurable packages – Development models 8
- 9. Key Objectives 9 patient safety productquality data integrity
- 10.
- 11. Main Body Overview •Key Concepts • Life Cycle • Quality Risk Management • Regulated Company Activities • Supplier Activities • Efficiency Improvements 11
- 12. 5 Key Concepts •Life Cycle Approach Within a QMS • Scaleable Life Cycle Activities • Process and Product Understanding • Science-Based Quality Risk Management • Leveraging Supplier Involvement 12
- 13. User and SupplierLife Cycles
- 14. Product and ProcessUnderstanding • Basis of science- and risk-based decisions • Focus on critical aspects – Identify – Specify – Verify • CQAs / CPPs 14
- 15. Life Cycle ApproachWithin a QMS • Suitable Life Cycle –Intrinsic to QMS • Continuous improvement 15
- 16. Specify Plan Verify Configure & Code Report RiskManagement A BasicFramework For Achieving Compliance and Fitness For Intended Use Figure xx: Figure 3.3: A General Approach 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. All rights reserved. GAMP V Model Transition VerifiesUser Requirement Specification Functional Specification Design Specification System Build Installation Qualification Operational Qualification Performance Qualification Verifies Verifies
- 17. Scaleable Life CycleActivities • Risk • Complexity and Novelty • Supplier 17
- 18. Science Based QualityRisk Management Focus on patient safety, product quality, and data integrity… 18 Assessment Control Communication Review Based on ICH Q9
- 19. Leveraging Supplier Involvement •Assess: – Suitability – Accuracy – Completeness • Flexibility: – Format – Structure • Requirements gathering • Risk assessments • Functional / other specifications • Configuration • Testing • Support and maintenance 19
- 20.
- 21. Compatibility with OtherStandards ASTM E2500 Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment 21
- 22. GAMP 5 Ongoing Operations GAMP 5 Reporting and Release GAMP5 Verification GAMP 5 Specification Configuration Coding GAMP 5 Planning GAMP5 and ASTM E2500 Good Engineering Practice Risk Management Design Review Change Management Requirements Specification and Design Verification Acceptance and Release Operations & Continuous Improvement Product Knowledge Process Knowledge Regulatory Requirements Company Quality Regs. The Specification, Design, and Verification Process – Diagram from ASTM E2500
- 23. Governance • Policies andprocedures • Roles and responsibilities • Training • Supplier relationships • System inventory • Planning for compliance & validation • Continuous improvement 23
- 24. Stages Within theProject Phase • Planning • Specification, configuration, and coding • Verification • Reporting and release 24
- 26. Planning • Activities • Responsibilities •Procedures • Timelines 26 See Appendix M1
- 27. Specification, Configuration, & Coding •Specifications allow – Development – Verification – Maintenance • Number and level of detail varies • Defined process 27
- 28. Verification • Testing • Reviews •Identify defects! 28
- 29. Supporting Processes • RiskManagement • Change and Configuration Management • Design Review • Traceability • Document Management 29
- 30. Design Review • Planned •Systematic • Identify Defects • Corrective Action • Scaleable – Rigor/Extent – Documentation 30See also Appendix M5
- 31.
- 32. GAMP 5 Categories CategoryGAMP 4 GAMP 5 1 Operating system Infrastructure software 2 Firmware No longer used 3 Standard software packages Non-configured products 4 Configurable software packages Configured products 5 Custom (bespoke) software Custom applications Continuum
- 33. GAMP 5 Quality RiskManagement 33
- 34. Critical Processes areThose Which: • Generate, manipulate, or control data supporting regulatory safety and efficacy submissions • Control critical parameters in preclinical, clinical, development, and manufacturing • Control or provide information for product release • Control information required in case of product recall • Control adverse event or complaint recording or reporting • Support pharmacovigilance (investigation of Adverse risks) 34
- 35. Definitions • Harm Damageto health, including the damage that can occur from loss of product quality or availability. • Hazard The potential source of harm. • Risk The combination of the probability of occurrence of harm and the severity of that harm. • Severity A measure of the possible consequences of a hazard. 35
- 36. Step 1 –Initial Risk Assessment • Based on business processes, user requirements, regulatory requirements and known functional areas 36Don’t repeat unnecessarily! Inputs Outputs GxP or non-GxP Major Risks Considered Overall Risk User Requirements GxP Regulations Previous Assessments
- 37. Step 2 –Identify Functions with GxP Impact • Functions with impact on patient safety, product quality, and data integrity 37 Specifications System Architecture Categorization of Components Inputs Outputs List of Functions to be further evaluated
- 38. Step 3 –Perform Functional Risk Assessments & Identify Controls Functions from Step 2 SME Experience Scenarios Possible Hazards 38 Breakdown of Risks to Low, Medium and High. Detailed Assessments and Mitigation for High Inputs Outputs
- 39. Functional Risk Assessment •Identify – Hazards and risk scenarios – Severity – impact on safety quality or other harm – Probability – Detectability 39
- 40. GAMP Risk AssessmentTool 40 Probability Severity Low Medium High Low Medium High Class 3 Class 2 Class 1 A simple two-step process: Plot Severity vs. Probability to obtain Risk Class
- 41. GAMP Risk AssessmentTool 41 Priority 1 Priority 3 Priority 2 3 2 1 High Medium Low RiskClass Detectability Plot Risk Class vs. Detectability to obtain Risk Priority
- 42. Step 3 (continued)Controlling the Risk 42 Mitigation Strategies • Change the process • Change the design • Add new features • Apply external procedures Scenarios with High Risk from Functional Analysis Inputs Outputs
- 43. Step 4 –Implement & Verify Appropriate Controls • Verification activity should demonstrate that the controls are effective in performing the required risk reduction. 43
- 44. Step 5 –Review Risks Monitor Controls Establish Periodic Review of Control Effectiveness Apply Risk Process in Change Management Activities 44 Frequency and extent of any periodic review should be based on the level of risk
- 45. Risk-Based Decisions What dothey impact ? • Number and depth of design reviews • Need for, and extent of, source code review • Rigor of supplier evaluation • Depth and rigor of functional testing 45
- 46. Operation Appendices • O1– Handover • O2 – Establishing & Managing Support Services • O3 – Performance Monitoring • O4 – Incident Management • O5 – Corrective and Preventive Action (CAPA) • Performance Monitoring • O6 – Operational Change & Configuration Management • O7 – Repair Activity • O8 – Periodic Review • O9 – Backup and Restore • O10 – Business Continuity Management • O11 – Security Management • O12 – System Administration • O13 – Archiving and Retrieval 46
- 47. Summary • GAMP 5provides more flexibility in the number and types of validation lifecycle products used. • Application of Risk and use of SME Knowledge are keys to success 47