How to support compliance with GAMP 5

Transcription

1 PRESENTATION How to support compliance with GAMP 5 KERESZTESI Kálmán Controsys Irányítástechnikai Kft. kalman.keresztesi@controsys.hu

2 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

3 GAMP 5

4 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 FOOD & Drug (pharmaceuticals) 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

5 Covarage

6 Publications in the GAMP series Source:

7 History of GAMP 1991: UK to satisfy FDA compliance 2000: Part of ISPE: worldwide recognision 2008: Issue GAMP 5

8 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) Source: 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.

9 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

10 Application Lifecycle Management in automation projects

11 GAMP 5: Risk based Approach

12 Life cycle of installed automation sytem

13 Project development phase: handling of SW Cat s 3

14 Project development phase: handling of SW Cat s 4

15 Project development phase: handling of SW Cat s 5

16 Project development phase: handling of SW Cat s Future implementation as per end user SOP 5

17 Life cycle with development and operations codebeamer codebeamer codebeamer codebeamer codebeamer

18 Implement GAMP 5 compliant processes in codebeamer ALM

19 Integrated GAMP 5 ALM in codebeamer Current implementation Based on end user SOP 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 Demand & Concept management Validation planning Initial risk and supplier assessment

20 Future Currently implemented in dedicated trackers Future

21 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

22 Intland's Pharma GAMP 5 Template features

23 Intland's Pharma GAMP 5 Trackers

24 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

25 Collaboration - Responsibilities Enduser Equipment Supplier System Integrator

26 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

27 Summary Intland 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

28 Invitation Coffee break Round Table on ALM in automation systems codebeamer ALM GAMP 5 implementation

29 Thank you for your attention!