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Miskolc-Lillafüred, Hotel Palota****

25-27 October 2017

How to support compliance with GAMP 5

KERESZTESI Kálmán

kalman.keresztesi@controsys.hu

Controsys Irányítástechnikai Kft.

PR

ESEN

TATI

ON

Miskolc-Lillafüred, Hotel Palota****

25-27 October 2017

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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25-27 October 2017

GAMP 5

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25-27 October 2017

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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25-27 October 2017

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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25-27 October 2017

Currently implementedin dedicated trackers

Future Future

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25-27 October 2017

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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25-27 October 2017

Intland's Pharma GAMP 5 Template features

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25-27 October 2017

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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25-27 October 2017

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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25-27 October 2017

InvitationCoffee break

Round Table on◦ ALM in automation systems◦ codeBeamer ALM◦ GAMP 5 implementation

Miskolc-Lillafüred, Hotel Palota****

25-27 October 2017

Thank you for your attention!

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