Ignite 2015 Stefan Artlich - To Each Drug Package its Own Unique Number - Is this Feasible and Does it Make Sense?

To Each Drug Package its Own Unique Number – Is this feasible, and does it make sense?

Dr. Stefan Artlich • Düsseldorf • 15 September 2015

Elemica IGNITE Europe 2015

Bayer Technology Services –

a Bayer Subsidiary

• Serialization and Track & Trace in Pharmaceutical Industry • Dr. Stefan Artlich Page 2

Holding Company

Bayer AG Corporate Center

Bayer HealthCare

Bayer CropScience

Covestro*

* formerly Bayer MaterialScience

Business Areas Service Areas

Bayer Business Services

Currenta

Bayer Technology Services

Employees 2,300*

Full Year Sales EUR 480 million**

Global network 22 offices in 10 countries

Bayer Technology Services

* Permanent or fixed-term contracts (in FTE)

** FY 2014

Competence Portfolio

Expertise, partner focused, holistic approach –

our basis for every solution.

Technology Development

Project Management

& Engineering

Operation Support & Safety


OPERATION SUPPORT & SAFETY

Industry-leading competences

and sustainable solutions for safe,

reliable and efficient operations.

Our Mission & Vision

We secure Bayer’s ability to

manufacture through production

processes and assets, that

• are safer and have best-in-class reliability,

• achieve higher quality and resource efficiency,

• and provide optimum productivity.

With our leading technologies, experts and

talents we are the global competence center

for Manufacturing Excellence within Bayer.


• Consulting and Project Management

for Product Verification

Services for Stakeholder Bodies

Our Footprint in Pharma and Agrochem

• Unique random serial number generator BayCoder ®

• Only company providing consulting and implementation services

from shop floor to top floor plus industry associations

• As owner’s engineer present in the market since the early days of T&T

Services for Manufacturers


Support for Manufacturers and Industry Stakeholders

Our Value Contribution: Track & Trace (T&T) –

Efficient and Reliable Coding & Serialization

Solutions

• BayCoder® software for performant generation

of randomized serial numbers

• Consulting, Project Management, Engineering

for Product Coding and Serialization

…

http://www.securpharm.de/index.html

Page 7

Agenda Serialization vs. Track&Trace: What does it mean?

It’s Real: Requirements in Pharmaceutical Markets world-

wide

Expected Benefits in Pharmaceutical and Other Industries

Building Blocks for Successful Implementation

Key Takeaways

• Serialization and Track & Trace in Pharmaceutical Industry • Dr. Stefan Artlich

Each drug package its own S/N –

Is this feasible?

Page 8 • Serialization and Track & Trace in Pharmaceutical Industry • Dr. Stefan Artlich

Serialization of items is state-of-the-art in consumer industry

Mobiles phones sold in

Western Europe (2014)

174.000.000

LCD TVs sold in

Western Europe (2014)

35.100.000

Prescription drug packages

sold in EU (2011)

5.278.000.000

GS1 provides de-facto standard for

pharmaceutical serialization

Tag each pack with four data elements

• Manufacturer Product Code

• Randomised Unique Serial Number

• Expiry Date

• Batch Number

Print information in human-readable format

plus 2D DataMatrix code

• GS1 2D DataMatrix code is advancement of EAN code

Example


Product #: (01)01234567890128

S/N: (21)123456789012

Expiry: (17)160930

Batch: (10)BXA6132

Engaging for patient safety in Europe –

Point-of-Dispense Verification Model


Unique Serialization with

Random Numbers

Wholesaler

Voluntary

Verification

Distributor

Pharmaceutical

Company

Pharmacies /

Hospitals

Mandatory

Verification upon

Dispense to

Patient

Verification

Repository

Upload Number

GTIN

Batch

Expiry

S/N

Patient

POINT-OF-DISPENSE PROOF OF CONCEPT

SWEDEN 2009 / 2010

For video please search for ‘EFPIA Coding Project’ on YouTube (starting at 03:39 min)

Full Track & Trace requires product verification by

each and every supply chain partner


Unique Serialization with

Random Numbers

Wholesaler

Mandatory

Verification

Distributor

Pharmaceutical

Company

Pharmacies /

Hospitals

Mandatory

Verification upon

Dispense to

Patient

Verification

Repository

Upload Number

GTIN

Batch

Expiry

S/N

Patient

Full Track&Trace requires Aggregation

from item to pallet

• Assign unique serial number to each object in packaging hierarchy

• Build and maintain parent-child relationship from single item to pallet

• In pharmaceutical industry full aggregation can extend across four levels:

Item, Bundle, Shipper, and Pallet

• On shipper and pallet level either GS1 2DMC or GS1 SSCC (‘Serial Shipping

Container Code’) are used


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wide



Key Takeaways


Serialization and Track&Trace in

Pharma is real and will further increase


EU Rx

Publication of Delegated

Acts expected in Q1/2016

Serialization, tamper

evidence

Go live Q1/2019

Korea Rx

French Coding (2013)

Serialization (2015)

China Rx, OTC

Aggregation of NEDL,

Blood Prod. (in effect)

Serialization of all

imports by Jan 2016

Turkey Rx, OTC

Serialization (2010) and

Aggregation (2012)

Brazil Rx, OTC

Serialization, Track & Trace

Pilot batches by Dec 2015

Go Live Dec 2016

Saudi-Arabia Rx, OTC, AH

French Coding (Mar 2015)

Serialization (Mar 2017)

Argentinia

Serialization for products

containing specific APIs

In effect

USA Rx

Serialization by Nov 2017

Track & Trace by Nov 2023

Benefits of Serialization and Track&Trace

Serialization

• Ensure patients’ access to safe medicines

• Detect counterfeit products at point-of-dispense

• Reduce reimbursement fraud

• Each pack is only reimbursed once

• Use random serial numbers in customer loyalty programs

• Entrance into / pre-requisite for implementation of Track&Trace

Track&Trace (if access to transactional data is established !!!)

• Improve supply chain mgmt. through increased supply chain transparency (e.g. regarding inventories, replenishment, service levels)

• Control distribution channels / grey market control

• Follow products through supply chain till they leave intended distribution channel



A Global Track and Traceability

Initiative of the Crop Protection Industry

Source:

Dr. D. Döhnert (BASF),

Frankfurt (Nov. 2014)

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Key Takeaways


Building Blocks for Implementation


• How do I print at 320 packs/min.?

• How do I coordinate packaging operations?

• Where to I draw samples?

• Collect transactional supply chain data

• In-house from production to shipping

• Driven by Authorities or Industry ?

• You will need to collaborate !!!

• Detect counterfeits

• Control distribution channels

• …

Business Objective

System Governance

Data Capture and Storage

Printing / Labelling / Shop Floor Operations

What’s In For You? – Key Takeaways

1. Serialization and aggregation provide promising benefits

2. Develop your business case now exploiting the current Digitalization hype

3. Plan for staged implementation using proven and robust technology

• Not everything that looks technically feasible is yet available as well

4. Do not underestimate time and effort for alignment with and coordination of

partners

• So far only few direct business-to-consumer scenarios exist


Email: [email protected]

Dr. Stefan Artlich Director Track&Trace Solutions Bayer Technology Services GmbH