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Presented by Leif Poulsen
Global Technology Partner
NNE Pharmaplan
DAPI-US Project Presentation for DAu 2016-05-31 1
Agenda
DAPI-US Project Presentation for DAu 2
Novo Nordisk and DAPI US Expansion1
DAPI US Operating Model2
Automation & IT Objectives3
Automation & IT Design Principles4
Automation & IT System Architecture5
Automation & IT Infrastructure6
Summary & Recommendations7
2016-05-31
Global leader in diabetes care The core equity story
Novo Nordisk at a glance
DAPI-US Project Presentation for DAu
R&D facilityManufacturingGlobal/regional headquarter
North America: Market share 37%
International Operations: Market share 55%
Japan & Korea: Market share 49%
Europe: Market share 47%
China: Market share 57%
Global insulin market share: 47%• A focused pharmaceutical company with leading positions
in diabetes, haemophilia and growth hormone
• Double digit top line growth driven by diabetes pandemic
• Significant growth opportunities fuelled by global
presence and strong R&D pipeline
• High barriers to entry in biologics
• Operating margin targeting 40%
• Operating profit growth targeting 15%
• Earnings conversion to cash targeting 90%
• Cash generated returned to shareholders
2016-05-31 3
Source: IMS MAT Feb 2015 volume figures, Roadshow 2015 Q2 presentation
2016-05-31DAPI-US Project Presentation for DAu 4
Business rationale: Diabetes API expansion in US
Satisfy demand for existing and new products
Satisfy growing demand for existing and future products primarily Victoza® and new innovative oral treatment of diabetes (currently in phase 3)
US providing access to talent
Expand with local presence in largest diabetes market and get access to large pool of skilled pharma talents
Supplement current API footprint in Denmark
Ensure dual source API supply to enhance robustness of Novo Nordisk supply chain
Demand
Supply
Expanding API production capacity in the US will enhance robustness of Novo Nordisk supply chain
DAPI-US Project Presentation for DAu 2016-05-31 5
1 2
DAPI US Key facts for project
DAPI-US Project Presentation for DAu 2016-05-31 6
The facility is expected to grow to ~700 FTEs when entering into operation in 2020
The facility will deliver API to primarily Victoza® and new innovative oral treatment of diabetes currently in phase 3
Total Project Cost estimated to ~USD 2 billion
Roughly 80,000 sq. meters and covering app. 85 acres of land
<Site billede>
DAPI-US Project Presentation for DAu 2016-05-31 7
DAPI US Operating Model
DAPI-US Project Presentation for DAu 2016-05-31 8
OperatingPrinciples
Roles CompetencesTrainingModules
TrainingPlans
BusinessProcesses
Employees
SOP’sMethods
& Systems
ManufacturingProcesses/Equipment
Step 1
Step 2
Step 3
DAPI US Aspiration
Organization
DAPI US Aspiration
9DAPI-US Project Presentation for DAu 2016-05-31
At DAPI US we are changing Diabetes
• We are ONE site, sharing ONE aspiration
• We ensure to build on best practice, aligning with colleagues in DAPI, Site Clayton and the rest of Novo Nordisk
• Our can-do attitude fuels our outstanding results
• Our quest for operational excellence is sustained by our broad and deep process understanding
• We must always be ready for inspection
• We balance our efforts for maximizing stability of our operations while maintaining a readiness for change
DAPI US additional systems
DAPI US Operating Principles10DAPI-US Project Presentation for DAu 2016-05-31
SAFETY BY DESIGN - SA1
SAFETY BY PROCEDURE – SA2
OPERATOR CENTRIC DEVELOPMENT – ST1
TRAINING IN SAFE ENVIRONMENT – ST2
CLEAR & SIMPLE PROCESS LANDSCAPE – ST3
DE-CENTRALISED CONTROL – VM1
BOARDS ON SHOP FLOOR – VM2
MINIMISE CHANGE-OVER TIME – PL1
FOCUS ON PRODUCT FLOW – PL2
DESIGN FOR MAINTENANCE – MT1
STRUCTURED CRITICALITY ASSESSMENTS – MT2
PAPERLESS MAINTENANCE SYSTEM – MT3
INTEGRATED MAINTENANCE PLANNING –MT4
ALL EMPLOYEES PERFORM SPS - PS1
PROCESS CONFIRMATION IN DESIGN – PC1
PROCESS CONFIRMATION IN DAILY ROUTINE – PC2
ELECTRONIC BATCH RECORDS – EBR1
ELECTRONIC WORKFLOW – EBR2
BATCH RELEASE BY EXCEPTION – EBR3
RISK & SCIENCE BASED CONTROL STRATEGY – MPU1
CONTINUED PROCESS VERIFICATION – MPU2
INTEGRATED PROCESS UNDERSTANDING – MPU3
Safety
Standards & Training
Visual Management
Planning
Maintenance
Systematic Problem Solving
Batch Release
Manufacturing Process Understanding
DAPI US Operating Principles
Process Confirmation
Impact
Impact on Facility design (Engineering Project)
Impact on Business Process design (Operating Model Project and Operations)
Impact on Organizational design (Operating Model Project and Operations)
DAPI US Manufacturing Processes11DAPI-US Project Presentation for DAu 2016-05-31
DAPI US Business Processes (Prioritized)12DAPI-US Project Presentation for DAu 2016-05-31
Management Processes
Core Processes
SupportProcesses
Discover and Develop Product
Supply and Sell Product
Vision andPolicies
Strategy andBusiness Planning
Organisationand Responsibility
IdentifyCustomer and Stakeholder
Requirements
DiscoverProduct
DevelopManufacturing
Process
EvaluateSafety
And Efficacy
ObtainApproval
FromAuthorities
PrepareCommercialisation
of Product
Plan Supplyof Product
Purchase forMarket and
Clinical Trials
Manufacturefor Market
and Clinical Trials
DeliverProduct
SellProduct
Ensure andMonitor
Customer andStakeholderSatisfaction
Procure andContracts
IT People Communi-cation
Finance andBudgeting
RegulatoryLicensing
QualityManagement
Facilitiesand
Environment
Legal, Risk Management, Patent and Trademark
Issues
Site Management
Operation
Selected Support
Description of Business Processes (Example)
13DAPI-US Project Presentation for DAu 2016-05-31
ProcessDescription
StandardOperationProcedure
Process Module
Diagram
Process Flow
Diagram
OperationFlow
Diagram
RequirementSpecification
FunctionalSpecification
BusinessProcessCartoon
Con
cep
tual
Desig
nB
asic
Desig
n
BusinessProcess
Swim Lane
BusinessProcess
Flow Chart
Example of High Level Business Process Description14DAPI-US Project Presentation for DAu 2016-05-31
Automation & IT Objectives & Expected Benefits
2016-05-31DAPI-US Project Presentation for DAu 15
Objectives
• Establish an operation centered Automation and IT solution with high availability
• Automation level aligned with operational needs
• Solutions where system and technology interfaces are clear and transparent
• Based on proven Information Technology from current Novo Nordisk production plants
• Segmentation of systems and network
• The operation of the process must to a high extent be done close to the equipment
• Uniform user interface
Expected Benefits
• Shop floor control and recording in electronic batch records to ensure regulatory compliance
• Consistent and reproducible work(right first time) through automated work instructions
• The solution will ensure that the process runs within predefined acceptable ranges and support automated data review
• Support troubleshooting and ensure record retention
• Materials tracking based on bar-coding of bags, containers and components to ensure genealogy
Design Principles16DAPI-US Project Presentation for DAu 2016-05-31
Area Principles
Ensure flexibility and availability
• Several instances of each system (MES, PCS, Historian, BMS)• Dedicated hardware (controllers and IO modules) and application software
for each section in each plant• Uniform user interface
Facilitate operation and monitoring close to the process
• Operator interfaces in proximity of the equipment• Use of mobile devices/tablets• Smaller monitoring rooms instead of large control rooms
Achieve IT Security and Data CIA (Confidentiality, Integrity, Availability)
• Redundancy in servers, locations and network• Network segmentation and separation of systems • Segregation of duties• Access from CORP domain
Electronic Batch reports • Electronic workflows for all primary processing steps included in MES• Exception based review and approval of batch• “Full” report provided
Implementing MES interface to SAP (PS@SAP)
• SAP will control the main warehouse• Eliminate manual entering of production orders, material usage, material
produced, check of material and equipment release status, etc.
Maintainability and total cost of ownership
• Design for easy maintenance and total cost of ownership rather than for minimum investment
17DAPI-US Project Presentation for DAu 2016-05-31IS
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Level 4
Bu
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Level 3
MES
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Level 2
Con
trol
Corporate Systems
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Level 1
In
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en
ts
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Level 0
Pro
cess
LAB& BMSSystem
PCS& BMSSystem
PCS& BMSSystem
BMSSystem
PCS & BMSSystem
Lab &Building
Instruments
Process& Building
Instruments
Process& Building
Instruments
Process& Building
Instruments
Process Instruments
Office& Labs
Fermentation& Recovery
Purification WarehouseSharedUtilities
WasteTreatment
Process& Building
Instruments
PCSSystem
HISSystem
MES& HIS
System
MES& HIS
System
HISSystem
HIS System
HISSystem
DAPI US Site System Architecture (Concept)
18DAPI-US Project Presentation for DAu 2016-05-31IS
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System Architecture for DAPI-US Version 1.0 prepared by LPOU 2016-04-03
DAPI US Plant System Architecture (Concept)
MESSystem
BMSSystem
PLC System
BarcodeEquipment
IPCTesting
PlantHistorian
BatchReporting
WeighingSystem
BuildingHistorian
PCS System
ProcessHistorian
ProcessInstrument
FMSSystem
PLC System
with SCADA
ERPSystem(SAP)
LIMSSystem
(NovoLIMS)
DeviationManagement
System(NovoGloW)
MaintenanceSystem
(SAP-PM)
Manu-facturing
Intelligence(MI)
ProcessInstrument
ProcessInstrument
ProcessInstrument
ProcessInstrument
Building”Instrument”
BuildingInstrument
AMSSystem
MaterialMovement
MasterDate
Update
MaterialMovement
ProcessOrder
ProcessStatus
MaterialConsume
MaterialProduce
InventoryAdjustment
BatchQA
StatusDeviations
QCSample
Data
MaintenanceStatus
Equipment Condition (e.g.
OperationHours)
ProcessData
Calibration Data
QualityData Deviations
MaterialData
MaintenanceData
BatchData
ProcessData, Critical
Alarms, ”Heart Beat”
Process Data, Alarms, Equipment Condition (e.g. Operation Hours), ”Heart Beat”
Calibration Data
WeighingData
TestData
BatchStart
MasterData
Update
CIPStart
EqpStatus
StartManualWorkFlow
CompleteManualWorkFlow
BatchData
BatchOrder Status
InputOutputSignal
InputOutputSignal
InputOutputSignal
InputOutputSignal
InputOutputSignal
InputOutputSignal
InputSignal
Commands/Response
Commands/Response
Calibration Data
SampleDataLabel
LaboratoryInstrument
QCTest
Results
RecipeMngt
RecipeMngt
RecipeMngt
PLC System
with HMI
ProcessInstrument
InputOutputSignal
Commands/Response
RecipeMngt
Process/utility coordination
Manual Interface
Automatic Interface
Automatic Interface
Partly New Historian Interface*
New AMS Interface
New MI Interface
Optional MI Interface
*Interface between PCSand Plant Historian is known
ProcessOrder
Completion
19DAPI-US Project Presentation for DAu 2016-05-31
Legend
Production Operations Management
Sensors & Actuators
Facility ControlProduction Control Inventory & Transport Control
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Op
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Quality Control
DrivesIn Line Analytics
(PAT)Smart IO SubsystemsActuators
FrequenceTransformes
SensorsAuto ID
(Barcodes/RFID)Data
Loggers
BuildingControl(BMS)
EnvironmentMonitoring
(PEMS)
SampleHandling
(NovoLIMS)
WarehouseControl
(Manual)
TransportControl
(Manual)
ProcessControl(PCS)
UtilityControl
(PCS/PLC)
QualityTest
(NovoLIMS)
Information Management
Human Ressource Management
Quality & ComplianceManagement
Supply ChainManagement
Maintenance Management
Manufacturing Development
Finance Management
ManufacturingIntelligence
(MI)
CommunicationMaterial
Requirement Planning (SAP)
Financial Accouning(SAP)
Laboratory Information Management (NovoLIMS)
Change Control(NovoGloW)
Non Conformity Handling
(NovoGloW)
SOP Management(QBIQ)
Sales & Distribution(SAP)
Inventory Management
(SAP)
Purchasing & Supply
Management(SAP)
Spare Part Management
(SAP)
Maintenance Management
(SAP)
Financial Investments
(SAP)
ProductDefinition
Management
Training Management
(IsoTrain)
PersonnelManagement
(SAP)
Master Data Management
(SAP)
ValidationDocument
Management(NovoDocs)
BatchReview &Release(SAP)
EquipmentDefinition
Management
Health & Safety Management
ProcessDefinitiont
Management
Material Reporting & Tracking (SAP)
Financial Controlling
(SAP)
Common Data Definitions
EngineeringDocument
Management(DrawTube)
Production DefinitionManagement
BOMManagement(MES/PCS)
Master RecipeManagement(MES/PCS)
SOPManagement
(QBIQ)
Prod. Perform. Analysis
KPIMonitoring
(MES, Option)
AdvancedAnalysis
(MES, Option)
BasicAnalysis
(Historian)
Production Tracking
PersonnelTracking
(MES/PCS)
EquipmentTracking
(MES/PCS)
MaterialTracking
(MES/PCS)
Production Data Collection
Electronic Batch
Recording(MES)
DeviationHandling
(MES, Option)
IPC Testing(MES)
Production ExecutionManagement
ProductionGuidance
(MES/PCS)
ProductionSupervision(MES/PCS)
ProductionSampling
(MES)
Production Dispatching
Control Recipe Generation(MES/PCS)
ProductionResource
Preparation(MES/PCS)
WorkOrder Dispatching
(MES)
Production Scheduling
Production Scheduling
(MES Option)
Production ScheduleRelease
(MES Option)
Production Schedule
Monitoring(MES Option)
Production Resource Management
PersonnelControl
(MES/PCS)
EquipmentControl
(MES/PCS)
MaterialControl
(MES/PCS)
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Finance &Logistics
(SAP)
OtherSystem
QualityManagement(NovoGloW)
Laboratory Information Management (NovoLIMS)
SOP Management(QBIQ)
ManufacturingIntelligence
(MI)
ManufacturingExecution
(MES/PCS)
ProcessControl(PCS)
BuildingControl(BMS)
Warehouse/Transport
Control(WCS/TCS)
Instrument
DAPI US Plant Application Architecture
Infrastructure
DAPI-US Project Presentation for DAu 2016-05-31 20
Secondary MPLS
PrimaryMPLS
Waste Plant
Computer Room (F)
Utility Plant
Computer Room (D)
Adm/Office Building
Main Server Room (A)
Fermentation Plant
Computer Room (B)
Purification Plant
Computer Room (E)
Warehouse
Main Server Room (G)
Recovery Plant
Computer Room (C)• Redundant fiber WAN network with two independent
MPLS-connections to the site. • Three network domains incl. AD:
• Enterprise Network, Business IT systems• Manufacturing/Production Network,
Manufacturing and Production IT applications (domain name – novoprod)
• Extra Secure Manufacturing/Production Network (Tier1), Manufacturing and Production IT applications that needs additional protection due to its sensitive content
• All communication between the administrative zones and manufacturing zones in the manufacturing network goes through a jump host in a special firewall DMZ zone
• Dedicated virtual subnets (VLAN’s) in each plant • Each subnet must be behind firewalls• Wi-Fi solutions enabled on all three types of
networks• Virtual infrastructure platform (VIP)• Test and Validation Environments included
21DAPI-US Project Presentation for DAu 2016-05-31DAPI US Hardware Architecture
Recommendation for Automation of Greenfield projects (initial steps)1. Establish Overview of Scope
2. Clarify Business Objectives
3. Understand Business Model
4. Identify Operating Principles
5. Understand Organization & Roles
6. Specify Business Processes
7. Specify Design Drivers e.g. Standardization, Flexibility, Robustness, Security
8. Adapt Level of Automation to Requirements
9. Specify Automation & IT Systems
10. Prototype Key Functions & Integration
2016-05-31DAPI-US Project Presentation for DAu 22
