how to support compliance with gamp 5 - controsys · new drugs in humans good regulatory practice...
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![Page 1: How to support compliance with GAMP 5 - Controsys · new drugs in humans Good regulatory practice (GRP), for the management of regulatory commitments, procedures and documentation](https://reader030.vdocuments.us/reader030/viewer/2022040113/5ed9fcc528db2d5ca2493473/html5/thumbnails/1.jpg)
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How to support compliance with GAMP 5
KERESZTESI Kálmán
Controsys Irányítástechnikai Kft.
PR
ESEN
TATI
ON
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Agenda
What is GAMP 5 about?
Application Lifecycle Management in automation projects
How to implement GAMP 5 compliant processes in codeBeamer ALM?
Intland's Pharma GAMP 5 Template features
Summary
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GAMP 5
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Good Automated Manufacturing Practice
GAMP: Name of subcomittee and the Guide
Core principles of GAMP◦ Quality cannot be tested in a batch of product
but must be built into each stage of the manufacturing process
◦ Covers all aspects of production; from the raw materials, facility and equipment to the training and hygiene of staff
◦ Assist pharmaceutical manufacturing companies in managing GxP Regulated systems
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
FOOD & Drug (pharmaceuticals)
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Covarage
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Publications in the GAMP series
Source: https://en.wikipedia.org
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History of GAMP
1991: UK to satisfy FDA compliance
2000: Part of ISPE: worldwide recognision
2008: Issue GAMP 5
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GxP-s
Good manufacturing practice (GMP), for food, drug products manufacture & sale
Good agricultural practice (GAP), for farming and ranching
Good laboratory practice (GLP), for laboratories conducting non-clinical studies (toxicology and pharmacology studies in animals)
Good clinical practice (GCP), for hospitals and clinicians conducting clinical studies on new drugs in humans
Good regulatory practice (GRP), for the management of regulatory commitments, procedures and documentation
Good distribution practice (GDP) deals with the guidelines for the proper distribution of medicinal products for human use
Good transportation practice (GTP) deals with the guidelines for the proper domestic and international transportation of medicinal products for human use
Good pharmacovigilance practice (GVP) deals with the safety of produced drugs.
Source: https://en.wikipedia.org
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GMP: Good manufacturing practice
GMPs are enforced in the United States by the U.S. Food and Drug Administration (FDA), under Title 21 CFR (Code of Federal Regulations)
◦ Practically enforces all companies worldwide exporting to US◦ cGMP: current Good Manufacturing Practices
World Health Organization (WHO) version of GMP
European Union's GMP (EU-GMP)◦ National Regulatory Agencies
UK Medicines Act, The Orange Guide by the MHRA (Medicines and Healthcare products Regulatory Agency)
Inspections by inspectorates◦ Unannounced (FDA – at a reasonable time, allowed in all open business hours)◦ Routine◦ Pre-approval
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Application Lifecycle Management inautomation projects
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GAMP 5: Risk based Approach
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Life cycle of installed automation sytem
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3
Project development phase: handling of SW Cat’s
4Future implementationas per end user SOP
5
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Life cycle with development and operations
codeBeamer
codeBeamer
codeBeamer
codeBeamer
codeBeamer
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Implement GAMP 5 compliant processes in codeBeamer ALM
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Integrated GAMP 5 ALM in codeBeamer Current implementation
Project related activities with intensive collaboration need
◦ Fully implemented
Operational phase activities ◦ Implemented
◦ Change management
◦ Observation, deviations
◦ Can be used but no dedicated trackers defined◦ Handover
◦ Patch and Update management
◦ Maintenance, Performance monitoring
◦ Repair
Based on end user SOP
Demand & Concept management
Validation planning
Initial risk and supplier assessment
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Currently implementedin dedicated trackers
Future Future
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Using GAMP compliant process in codeBeamer ALM
Install codeBeamer ◦ Own Windows/Linux server (or Docker environment)◦ Subscribe for SaaS (reluctant in pharma area)
Import Intland’s GAMP 5 Template
Customize template if required (complete redesign possible)◦ User roles◦ Workflows◦ etc.
Make use of customised codeBeamer installation◦ Add users and groups◦ Populate work items and config items◦ Specify, review, test, trace, baseline……
1 hour – 5-10 days based on customisation need
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Intland's Pharma GAMP 5 Template features
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Intland's Pharma GAMP 5 Trackers
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Workflow example
Software design specification workflow:
All workflows are configurable◦ States & Transitions◦ Colors◦ Automatic backgound functions◦ Permissions, etc.
Actual workflow is special to GAMP 5,config tools are generic in codeBeamer
Review & Approval options◦ Workflow based◦ Review HUB based (items groupped)◦ Electronic signature option◦ Multiple reviewer & approver supported
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Collaboration - ResponsibilitiesEnduser
Equipment Supplier
System Integrator
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Tracker relations – key feature in compliance
Based on◦ Built in GAMP rules◦ Collaboration - responsibilities seen on previous slide
Result: the Traceability browser relations
Enable users to ◦ Direct create referring items (use the „+” in Document view)
◦ URS item -> FS item
◦ FS item -> SCS or SDS item◦ etc.
◦ Navigate to related incoming references
Live visualization within codeBeamer◦ Configuration diagram
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SummaryIntland’s GAMP5 template is a hybrid framework (Waterfall – Agile)
◦ Better response to actual challenges in pharma implementations◦ Full compliance◦ Process control flexibility◦ Complete transparency◦ Offers good ROI (dependent of customer approach – conservative/open)
Current template is project oriented with DevOp features limited ◦ From approved URS to PQ by end user◦ Includes all Functional, System (hw+sw), and Application Design & Verification◦ SCM usable for source file oriented process control systems only (estimated to stay
very limited indeed)◦ Human resources for functional extensions are available
Actual project at Sanofi, in prep. at Gedeon Richter, in use at ABBHU
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InvitationCoffee break
Round Table on◦ ALM in automation systems◦ codeBeamer ALM◦ GAMP 5 implementation
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Thank you for your attention!
www.controsys.hu