ISPE New Jersey Chapter
Professional Development Day
March 20th,2014
Today’s Discussion Points
1
Serialization Definitions and Drivers
2
Compliance Strategy
3
Operational Governance
4
Deployment Strategy
5
Early Lessons Learned
2
SERIALIZATION DEFINITIONS & DRIVERS
3
Business Drivers
• Patient Safety: Insure the integrity of pharmaceutical
products throughout the supply chain
– Counterfeiting deterrent
– Deter re-introduction of stolen goods into supply chain (with T&T)
– Allows “Authentication” through the supply chain
– ePedigree – confirmed movement through legitimate supply chain
• Compliance: Increasing regulations (US and Global)
– US legislation: requires ePedigree with pathway to Track and
Trace. Unit level serialization by Nov 2017.
– EU Falsified Medicines Directive: requires serialization and
tamper evidency in ~2017/2018 through EU country delegated
acts (with pharmacy authentication)
– Emerging Markets: (Argentina, China, Turkey, India, etc.) have
enacted Serialization regulations typically requiring Trace &
Trace
4
Definitions: Regulatory Impact on Operations
Serialization
GS1Standards
 Applying a unique identification code to the retail unit of sale
Authentication
 Confirming the authenticity of the unique identification code,
typically at the point of dispense
Track and Trace
 Determining the location of product as it moves through the supply
chain
ePedigree
 Documenting the chain of ownership of the product as it moves
through the supply chain
Aggregation and Inference (required for T&T)




Every item, case and pallet is assigned a serial number
Items are aggregated to cases (parent / child relationship)
Cases are aggregated to pallets
Unit level serial numbers can be “inferred” by reading the case or pallet serial number
5
COMPLIANCE STRATEGY
6
Compliance Strategy
•
Included as one component of a
comprehensive supply chain security
program
•
Work with industry groups to
understand and help develop
standards and influence the approach
(e.g., PhRMA, EFPIA, GS1, Rx 360)
•
Market alignment process to clearly
understand the requirements for
successful deployment
•
Understand the global landscape to
minimize impact to your design
strategy
•
Tracking SKU compliance
7
Market Compliance Enablement
Serialization
PMO
Market
Market
Enabling
WS
External
Supply
Enabling
WS
Supply
Network
Enabling
WS
Monitoring
Activity:
• Actively monitor
mandates
• Monitor in
program local
solution
• Monitor in
program
enterprise
solution for
requirement
changes
BT
Enabling
WS
Market
Enabling
Core Team
Market
Mfg
Market
GL&S
Logistics
/ SC
Enabling
WS
Evaluation
Activity:
• Determine initial
scope and
sourcing strategy
for mandate
• Document
mandate
compliance
milestones
• Request and
approve program
funding
• Initiate market
engagement
Engagement
Activity:
• Form local
market team and
meeting cadence
• Finalize approach
and design for
scope
• Update
Enterprise master
schedule to
include identified
enablement
activities
Market
Reg.
Affairs
Enablement
Compliance
Management
Activity:
Activity:
• Coordination of
• Onboard
schedule and
SKUs within
resources
the network
• Enable impacted • Monitor and
Pfizer supply
track SKU
chain
onboarding /
• Enable data
compliance
management
across Pfizer
supply chain
• Enhance
Enterprise
solution
Market
Artwork
BU
Mgt
Business as
Usual
Activity:
• Transition supply
chain and
enabling functions
to standard
operational
activity
• Ongoing
monitoring
Serialization Data
to/from Site Lines
External
Internal
Global Landscape
Authentication
2017 / 2018
FR
DE
EU Member
Markets
EFPIA
Serialization
Control Tower
(SCT)
(Europe)
ES
Data Updates
UK
Phasing
Lot – 2015
SN – 2017
WH – 2019
T&T – 2023
India
China
(Export)
(Import)
Enterprise Solution
LSP (O2C WH)
(Domestic)
In-house (WMS WH)
Non-Serialized
Products from Mfg
Local Solution
China
Argentina
Turkey
Mandate Evaluation
Distribution Serialized Product
Data (Manual / Local BT
Solution)
Non-Core Examples
Serialized Products
from Mfg
9
OPERATIONAL GOVERNANCE
10
Program Governance
Program Governance
• Corporate spokesperson
• Communicate business impact
• Elevate issues to Executive Leadership Team (ELT)
Executive Sponsor
Supply Chain
Security
Program Governance Committee
Program Operations
PMO Steering Team
•
•
•
•
Endorse Program Deployment /Compliance Plan
Endorse cost avoidance strategies (sourcing changes)
Endorse investment deferrals and associated risks
Participate in quarterly updates and elevate issues
•
•
•
•
•
Oversight and guidance of PMO workstream activities
Establish core solution strategies and scope
Obtain funding for workstream resources
Establish and monitor Program Deployment/Compliance Plan
Stakeholder communication and awareness
• Day to day management of PMO
• Coordination of workstream activities
• Development of program metrics
PMO Program Leads
Supply Network
Enablement
Capital Controls &
Optimization
BT Solution
Enablement
External Supply
Enablement
Industry Alignment /
Customer Engagement
Logistics & Supply
Chain Enablement
End User Chg Mgt
& Training
Market Enablement
& BU Engagement
Program Financial
Management
Program Operations
11
Steering
Committee
Program Operations
GTS – GE
PGS BT
External Supply
Trade
Market
Enablement
GTS – Packaging
Program CoLeads
GL&S
Program CoLeads
Program Leads
PMO
Supply Network
Enablement
• Solution Platform
Architecture
• Site Line Deployments
• SKU Compliance
Capital Controls &
Optimization
• Capital Planning &
Optimization
• Capital Funding &
Controls
• Capital Reporting
Logistics & Supply
Chain Enablement
• Global Process Mgt
• Logistics Deployments
• Supply Chain SKU
Onboarding
End User Chg
Mgmt & Training
•
•
•
•
•
•
“Operationalize”
Serialization
End User / Process
Change Mgt
CI
BT Solution
Enablement
• Data Management
Architecture
• Solution Deployments
• MDM
Market
Enablement & BU
Engagement
• Country Engagement
• Market Regulatory
Requirements
• Market Enablement
External Supply
Enablement
• CMO Project /
Relationship Mgt
• CMO Line Deployments
• CMO Funding Model
Program Financial
Management
• CPA Allocation
• Oper Cost Impacts
• Operational Budgeting,
Forecasting & Accounting
Enterprise wide representation, participation and collaboration
Matrix organization with defined and integrated roles and responsibilities
Sourcing strategy for External & Internal site packaging lines
Industry
Alignment / Cust
Engagement
• E2E Pilots
• Industry Engagement
• Policy & Regulatory
Influence
Program
Operations
• Network Compliance
• Scope & Change Mgt
• Schedule Mgt
12
DEPLOYMENT STRATEGY
13
Deployment Strategy
•
Engage with Suppliers and Logistic
Service Providers to create awareness,
provide solution assistance and build
capabilities
•
Adapt work processes in line with
Serialization and Traceability
requirements on network supply and
distribution strategies/practices
•
Build Serialization and Traceability
competencies throughout the network
•
Establish flexible technical solution based
on standards are deployable in modules
•
Develop a master plan to track and
achieve compliance
14
Operating Model
Program Operations
Activity:
• Coordinate alignment of all workstreams to ensure successful mandate
compliance
• Management of Enterprise schedule
• Report Program and mandate status
Monitoring
Activity:
• Actively monitor
mandates /
regulations not in
scope of program
• Monitor in program
local solution
requirement
changes
• Monitor in program
enterprise solution
for requirement
changes
• Monitor and bring
back learnings
from pilots
Evaluation
Activity:
• Determine initial
scope and
sourcing strategy
for mandate
• Document
mandate
compliance
milestones
• Request and
approve program
funding
• Initiate market
engagement
Engagement
Activity:
• Form local market
team and meeting
cadence
• Finalize approach
and design for
scope
• Update Enterprise
master schedule to
include
enablement
schedules from all
workstreams
impacted
• Secure site /
source funding
•
•
•
•
Manage Issue and risks
Monitor and track progress across all in scope mandates
Manage program communications
Manage program scope and financials
Enablement
Compliance
Management
Activity:
Activity:
• Coordination of
• Onboard SKUs
schedule and
within the network
resources
• Monitor and track
• Enable impacted
SKU onboarding /
internal supply chain
compliance
• Enable data
management across
internal supply chain
• Enhance Enterprise
solution
• Lead change
management and
training across internal
Supply Chain
• Transition to Enterprise
support
Business as
Usual
Activity:
• Transition supply
chain and enabling
functions to
standard
operational activity
• Ongoing
monitoring
15
*Phases may occur in parallel or cyclical nature
Deployment Strategy
• Understand Regulatory Landscape
 Markets Served – US, EU and Emerging Market (i.e. Argentina, China, India,
Korea, Columbia, Brazil, etc)
• Product Portfolio vs. Line Allocation
 Line Consolidation
 Deferment Consideration
• Line Assessments
 Process Flow/Mapping - > Alignment and application of appropriate Global
Solution
 Asset - Upgrade, Redeploy vs. New
 Collection and management of Master Data
 Artwork Change Management/Guidance Documents
• Impact on Supply Network
16
Packaging Line Serialization
S95 Level
Level 4
SCT
ERP/SAP
Enterprise Control
Level 3
Site Serialization Controller
Site Control
Level 2
Line Serialization Controller
Line Control
Level 1
P/V
Device Control
Level 0
Devices
Enterprise Level
Cartoner
P/V
A/P/V
A/P/V
Case
Packer
A/P/V
Palletizer
= Print & Verification: Inkjet or laser printer, camera, Level 1-2 Controller
= Aggregate, Print & Verify: Inkjet printer, Camera/Scanner, Controller Interface
= Standalone Material Handler, labeler or checkweigher
Packaging Line enabling prerequisites:
1. Delivery of required equipment (e.g., new labeler or case packer)
2. Developing SKU artwork
3. Compiling SKU master data (+50 elements / SKU)
4. Availability of Serialization Solution Partner SME
5. Availability of Serialization SME
6. Availability of BT Serialization SME
7. Availability of production window (3 to 6 weeks of downtime)
17
Online Serialization & Aggregation
Unit Level
Serialization
Cartoner
P/V
A/P/V
Conveyor
Case
Case
Packer
Packer
P/V
A/P/V
Labeller
Case
Case
Packer
Packer
Case Level
Aggregation
Online Serialization
& Aggregation (blisters)
Online Serialization
& Aggregation (bottles / vials)
P/V
Cartoner
Conveyor
Case
Case
Packer
Packer
Online Serialization
Authentication blisters
P/V
Labeler
Case
Case
Packer
Packer
Online Serialization
Authentication bottles / vials
18
Unit Serialization & Aggregation Alternatives
Cartoner
(blister)
P/V
A/P/V
Conveyor
Case
Case
Packer
Packer
Unit Level
Serialization
Case Level
Aggregation
Online Aggregation
for high volume SKUs
Online Serialization & Aggregation
A/P/V
P/V
Cartoner
(blister)
Case
manual or
Packer
semi-automatic
case packing
Conveyor
Unit Level Serialization
Postponed Aggregation
A/P/V
P/V
Cartoner
(blister)
Case
manual or
Packer
semi-automatic
case packing
Conveyor
Unit Level Serialization
Postponed Aggregation
performed at second site
Postponed Aggregation
P/V
A/P/V
Conveyor
Case
Case
Packing
Packer
Vial Filling
Brite Stock
Postponed Aggregation
for low volume SKUs
(same site)
Serialization & Aggregation
Brite Stock
Postpone Serialization &
Aggregation
at second site
19
Supply Network Impact
Serialization Supply Network Landscape
Line 1
Impact on Sites
Line 2
• Capacity impact from
deployments
(3-6
weeks downtime)
• OEE impact
• Reduced agility for SKU
movements between
pkg lines
• Exception handling
Line 3
Line 4
Sites
Line 5
Site Warehouses
• Schedule based on
serialized lines
• Manage serialized and
non-serialized product
• Aggregation rework
• Sampling
• Track shipments
• Update serialization
information in the SCT
Line 6
3rd Party Contract Operations
•
•
•
•
Extensive collaboration needed - understanding requirements and delivery
Dynamic schedule: changing mandates and vendor readiness
Agreement on commercial impact (COGS impact vs. funded capital)
Opportunity to consolidate to fewer suppliers
20
EARLY LESSONS LEARNED
21
Early Lessons Learned
• Start Early – pilot early and often
• Do not underestimate complexity… especially
information technology aspects
• Partner with your serialization provider and align
on the deployment schedule
• Build technical and operational knowledge
• Keep your antennae up – don’t ignore changing
signals
• Consider all impacts to your organization
• Develop tools and toolkits to enhance
competencies through your organization
• Communicate, communicate, communicate –
never too much
22
Mark Wessel
Global Serialization Program Leader
Global Technology Services
Pfizer Global Supply
23