Vision Pharma 2014 - Serialization How to deal with emerging country regulations and multi-markets requirements Daniel Yuen, Project Manager, Global SPT Program, Novartis Pharma AG 03 June 2014, Stuttgart, Germany "The use and property of this presentation belongs exclusively to Novartis and/or its affiliates Novartis does not make and expressly disclaims: (a) any representation or warranty (express or implied) with respect to the Information show in this presentation, (b) any liability relating the accuracy or completeness of the Information. "
Agenda
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Novartis Pharma - company profile
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Technology platform
How to deal with emerging country regulations and multi-markets requirements Core approach Standardization
Our Focus Is On Patients
Our mission is to care and cure Novartis products reached 1.2 billion patients around the world in 2013
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| PharmaVision 2014 | Daniel Yuen | June 2014 | How to deal with emerging country regulations and multi markets requirements | Business Use Only
Product Portfolio Spans High-Growth Healthcare Segments 2013 sales by segments Total Sales 57.9 Billion USD Consumer Health
Pharmaceuticals
Innovative patent-protected medicines
Alcon
Global leader in eye care with surgical, ophthalmic pharmaceuticals and vision care
Vaccines
7%
3%
Sandoz
16% Sandoz
Affordable, high-quality generic medicines and biosimilars
56% 18% Alcon Pharmaceuticals
Self-care brands for Consumer Health consumers and veterinary (OTC and AH) medicines for pets and farm animals.
Vaccines
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Vaccines to protect against life-threatening diseases
| PharmaVision 2014 | Daniel Yuen | June 2014 | How to deal with emerging country regulations and multi markets requirements | Business Use Only
Agenda
Novartis Pharma - company profile How to deal with emerging country regulations and multi markets requirements Technology platform
Core approach Standardization
Novartis Pharma Product Security Program Enhance supply chain security, patient safety and regulatory compliance
Verification Features
Tamper Evident
Serialization and Product Tracking
Novartis Pharma Product Security Program 6
| PharmaVision 2014 | Daniel Yuen | June 2014 | How to deal with emerging country regulations and multi markets requirements | Business Use Only
Concept of Serialization Product Tracking (SPT) Complexity increases significantly from A to C
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| PharmaVision 2014 | Daniel Yuen | June 2014 | How to deal with emerging country regulations and multi markets requirements | Business Use Only
SPT Regulations And Implementation Priorities Focus in 2014 is South Korea and China Serialisation and aggr.
We are here
Brazil
Argentina
Sales Unit
Brazil pilot
Bundle
Turkey
Shipper Pallet
Serialization Complexity
US, Federal
China, phase 2 (imp) China, phase 1 (dom) Europe
Serialisation Turkey
India (export)
Ukraine
Saudi Arabia South Korea
Online Coding
France
South Korea
Tamper Evident
Canada
US, Federal
Batch traceability
Tamper Evident
Saudi Arabia
US, Federal
South Korea
Saudi Arabia
Europe
2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 For simplification reasons other countries with enacted or emerging regulations like Nigeria, Mexico etc. are not listed 8
| PharmaVision 2014 | Daniel Yuen | June 2014 | How to deal with emerging country regulations and multi markets requirements | Business Use Only
What Are The Major Challenges? Uncertain external and internal environments New regulations emerge continuously but requirements are not always clear Frequent change of regulation deadline and scope Product transfer in own manufacturing network and 3rd party packagers
Cost challenge Implementation at maximum cost effectiveness Implementation costs in different scopes and environments can vary significantly
Efficiency challenge Implementation duration, especially line down time, as short as possible OEE impact as low as possible
Immature technology and not well understood Solutions in the markets are not all stable and mature Users underestimate technical challenge and impact on processes
Resources limitation Limited supply of resources with the sufficient knowledge and experience Long learning curve 9
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How Do We Overcome The Major Challenges?
Major Challenge Uncertain environments Cost challenge
Long Term Implementation Planning. Implement where it is absolutely necessary
Efficiency challenge Immature technology
Resources limitation
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Core Approach, meaning standardized solutions, standardized environment and standardized execution approach.
| PharmaVision 2014 | Daniel Yuen | June 2014 | How to deal with emerging country regulations and multi markets requirements | Business Use Only
Implementation Planning – Plan Early and Long Term Is Key
Prune product(s) If investment higher than sales, not a Life saving product, alternative products are available
Other considerations Additional investments required? Other legal requirements like Tamper evident required? IT Infrastructure can be shared?
Offline solution Use offline manual solution instead of automated solution if volume is low
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Transfer product(s) Transfer to another site where capability already in place. Use 3rd party
Line consolidation Concentration of volumes on limited number of lines if possible
| PharmaVision 2014 | Daniel Yuen | June 2014 | How to deal with emerging country regulations and multi markets requirements | Business Use Only
• Planning is more than just making the MS Project Plan early. • Also need to get the solutions ready, get the resources lined up early enough, plus alignment on all levels. Be prepared for changes. • Need to understand and accept these require upfront significant effort but with little short term payback.
Core Approach – Standardization Is Essential Standardized infrastructure, e.g. IT infrastructure, manufacture equipments
Standardized technical solutions that are capable, configurable, scalable and maintainable Standardized business processes
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Standardized project execution and operation approach
Standardized qualification approach, documentation, language
| PharmaVision 2014 | Daniel Yuen | June 2014 | How to deal with emerging country regulations and multi markets requirements | Business Use Only
Agenda
Novartis Pharma - company profile How to deal with emerging country regulations and multi-markets requirements Technology platform
Core approach Standardization
Technical Platform and System Landscape Engineering Solution in Local Packaging
Central IT Solution in Headquarter
Alarms
Site MES
ECC ERP
SPT Line System
3rd party EPCIS
Serial numbers
Batch and Product data
PI Serial hierarchy
Packaging Machine
Printer
Camera
RFID device
RFID Printer Camera Mobile Fixed device Reject Labeler reader reader RFID Printer Camera device
Packaging Line Packaging Line
OER
Aii
SPT Site Server Device Control
Packaging Line Fix Reader
Mobile Mobil Reader
Label printer
Warehouse, Distribution Center Warehouse, Distribution Center Warehouse, Distribution Center MES = Manufacturing Execution System Aii = AutoID Infrastructure OER = Object Event Repository PI = Process Integration
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IT Solution in Local Warehouse/DC
| PharmaVision 2014 | Daniel Yuen | June 2014 | How to deal with emerging country regulations and multi markets requirements | Business Use Only
Health Health Health Authority Authority Authority database database database
Novartis Core Approach – How is it Implemented? A Set of Globally Managed Standardized & Modular Solutions SPT Line System Packaging Machine
Printer
Camera
RFID device
RFID Printer Camera Mobile Fixed device Reject Labeler reader reader RFID Printer Camera Mobile Fixed device Reject Packaging readerLine reader
Module 5 SPT Site Server
Fixed Mobile Reject Packaging readerLine reader
www.pester.com www.systech-tips.com
Packaging Line
Module 1 www.pester.com www.systech-tips.com
www.visio-pharma.com www.seidenader.de
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www.seidenader.de
| PharmaVision 2014 | Daniel Yuen | June 2014 | How to deal with emerging country regulations and multi markets requirements | Business Use Only
Novartis Core Solutions – What are included? • Predefined hardware, software, configurations that together deliver predefined functional capability. www.pester.com www.systech-tips.com
www.pester.com www.systech-tips.com
www.seidenader.de
• Predefined integration design into underlying packaging machine such as case packer. • Standard system lifecycle and qualification document packages, including URS, DS, FRA, FAT, IQ/OQ. • Solution is pre-qualified on global level. Local qualification focus on local specific configurations and high risk functions only.
www.visio-pharma.com
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www.seidenader.de
• Global guidelines to standardize rollout and operation approach.
| PharmaVision 2014 | Daniel Yuen | June 2014 | How to deal with emerging country regulations and multi markets requirements | Business Use Only
Novartis Core Approach – Critical Success Factors
www.pester.com www.systech-tips.com
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Management support and commitment
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Diligent supplier selection. Maintain stable and long term supplier relationships
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Centralized control for project execution as well as for lifecycle management
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Standardization of operating environments
www.pester.com www.systech-tips.com
www.seidenader.de
www.visio-pharma.com
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Business processes
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IT infrastructure and backbone systems, e.g. ERP
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Packaging machines
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Product format and design
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Qualification and documentation approach.
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Training
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Communications and Alignment on all levels, including suppliers
www.seidenader.de
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| PharmaVision 2014 | Daniel Yuen | June 2014 | How to deal with emerging country regulations and multi markets requirements | Business Use Only
Novartis Core Approach – Measurable Benefits
Note
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Advantage
Qualitative / Quantitative Benefits
Cumulate and share of know-how and experiences.
Improved quality and efficiency. Achieve OEE targets.
Leverage global documentation and global qualification results.
Cost reduction of USD 30’000 - 60’000 per line.
Faster implementation and shorter down time with lower risk of failure.
Cut line downtime during installation by 50%. Cut project turnaround time by 30%. Cost reduction USD 100’000 per line.
Easier and faster software update.
Lower maintenance and lifecycle management cost. Time for upgrade cut by 70%.
Achieve economies of scale.
Increased discount rate by 100%. Better services due to higher priority is given by supplier.
Quantitative figures are rough estimates based on Novartis learning. | PharmaVision 2014 | Daniel Yuen | June 2014 | How to deal with emerging country regulations and multi markets requirements | Business Use Only
Summary • Serialization implementation is complex and challenging in many areas. • Take action early and plan for long term is critical. • Standardization is key to success. Not only technical solution but also operating environments require standardization. • Last but no least, get buy in from all who will be impacted early enough - stakeholder management and change management.
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Questions & Answers
Thank You!
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| PharmaVision 2014 | Daniel Yuen | June 2014 | How to deal with emerging country regulations and multi markets requirements | Business Use Only
Global Serialization and Product Tracking Program
"The use and property of this presentation belongs exclusively to Novartis and/or its affiliates Novartis does not make and expressly disclaims: (a) any representation or warranty (express or implied) with respect to the Information show in this presentation, (b) any liability relating the accuracy or completeness of the Information. "
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| PharmaVision 2014 | Daniel Yuen | June 2014 | How to deal with emerging country regulations and multi markets requirements | Business Use Only
