Mathieu Aman, F

17 Pages·2014·1.13 MB·English

Mass Serialization and Traceability
Implementation in the Pharma Industry
Mathieu Aman, Global Program Lead
F. Hoffmann-La Roche Ltd, Switzerland
What drives the industry towards more “traceability”
Strategic thinking & a long-term vision required
Roche's roadmap
A few Take-home messages
An ongoing focus towards more control & security in
todays’ global Pharma Supply Chains
The Importance of Packaging is Increasing in Pharma
Global Supply Chain
Regulators Customers Brand Protection SC visibility & Control
Threats / Challenges
External drivers Internal drivers
 counterfeits
Product security  diversion
 theft
Patient safety  bed-side scanning
 avoid medication error
through Barcoding & a  5 patient’s rights
safer Product Identification  mobile computing authentication
Process integrity
 chain of custody / accountability
& Transaction  protect industry reputation
 combat re-imbursement fraud
security
 supply chain visibility
with Traceability at Sales  trust
Unit level  recall effectiveness
E-supply-chain &
 m-health / e-services
Digitization
 e-leaflet
 mobile computing authentication
as a transformational and
 sales unit level data (payers)
sustainable trend
3
An ongoing focus towards more control & security in
todays’ global Pharma Supply Chains
The Importance of Packaging is Increasing in Pharma
Global Supply Chain
Regulators Customers Brand Protection SC visibility & Control
Threats / Challenges
External drivers Internal drivers
Product security
MAH’s responsibility:
Increase Confidence &
Patient safety Demonstrate evidence that
product is safe & secure from
through Barcoding & a
safer Product Identification manufacturing till it reaches the
patient
Process integrity
& Transaction
security Building in intelligence and
sophisticated features into
with Traceability at Sales
Unit level primary & secondary packaging
E-supply-chain &  “Interactive” packaging
Digitization
 “intelligent” packaging
as a transformational and
sustainable trend
4
The outcome: the sales units gets unique and tamper-proof
A unique number to identify each single tamper-proof sales pack
Roche is global GS1 member
new
new

N Serial Number
Material Number
O
• A unique number assigned
I GTIN / NTIN
T
to a single unit
A
Z • A randomized numeric code
I
L
A
I
R
E
S

d
n new
a
Data Carrier

G
N Machine readable
I
D
O Overt/Covert Anti-
C Counterfeiting features
-
D
2

:
1

l
e
v Tamper Evidence
e
Human Readable
L
Information
5
What drives the industry towards more traceability
Strategic thinking & a long-term vision required
Roche's roadmap
A few Take-home messages
Strategic thinking & a long-term vision

Vision
ideal state
Roche approach:
Maximize Biz. Value
Vision + backward planning
2016
3
e
c
n
a
m
Ramp-Up/ Deploy
ro 2013
f
re 2
P

e
s EU VPD
ir Proof-of-concept
p
r 2010
e
t 1
n
E
Korea SER
la TE …
t
o
T
Brazil T&T
E-pedigree
What we didn’ t want:
2009
«Classical» Incremental
French approach
Coding
Think BIG Start SMALL Scale FAST 7
Where do we see this journey going…
Do not focus on one specific requirement; Instead, put in perspective

From Product Security… … to Transaction Security & Digitization
E-services
Traceability

IV
l III
e Serialization
v
e M- services
l

tn Technical Secure e-Supply Chain
e II
m
security
t
s
e
v measures & Tamper Evidence
n
I The country maps
indicate what the country
targets as of today
I
< 2010 2015 2020
8
Strategic thinking & a long-term vision
What our approach is from beginning
• A cross functional global effort
 ensure standardization, interoperability and integration
 Strong global drive & close cooperation with local implementation teams / SME’s
 This is not only a technical project
• Develop and implement an adaptable/scalable technical standard solution
 Co-develop with vendor
 A constant mix of prototyping, conceptual design and operational
implementation
• Work together with other stakeholders
 authorities, standard bodies, associations, peers, trading partners, vendors…
Accept the challenge as an opportunity
Success through a collaborative approach 9
What drives the industry towards more traceability
Strategic thinking & a long-term vision required
Roche's roadmap
A few Take-home messages