Serialisation in Life Science: Time to Harness the Opportunity€¦ · A Proven Serialisation...

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Serialisation in Life

Science:

Time to Harness the

Opportunity

... bridging your enterprise and your plant

1


Eamonn O’Mathuna

Personal Introduction

Over 26 years as Systems Expert in Big Pharma

Automation Team Leader on Serialisation Project in

Genzyme Waterford

Joined ESP in 2012 as Manufacturing Systems

Consultant, expert in MES, Automation and

Serialisation solutions

Currently Project Manager on Serialisation Rollout in

Teva Runcorn, UK

2


Enterprise System Partners

Enterprise System Partners (ESP) is a Global

Consultancy Company specialising in;

» Manufacturing Execution Systems (MES)

» Serialisation, Track & Trace

Also ERP & Process Automation but primarily in support of the

above

3


Enterprise System Partners

A Global Track Record of Success

Medical Device

Pharmaceutical /Biotechnology

4


Agenda

Understanding the Impact of Serialisation on Business

The Business (Case) Drivers for Serialisation

Optimising Your Serialisation Investment

A Proven Serialisation Strategy

Standardisation – An Effective Approach – A Case

Study

Impact on Business Business Drivers Optimise Investment Strategy Effective Approach

5


The Impact of Serialisation on

Business


Serialisation isn’t new…

…it has been in industry for decades

1990’s 2000’s 2010’s

Pacemaker

6




Business

7

» Put a serial number on a box.

» Read it into a database.

» Job Done?

Do We Underestimate Serialisation?


End to End (European EFPIA Approach)

Closing Comments Execution Business Drivers Big Picture Fundamentals Overview

8

Serialization Types

Source : EFPIA European Medicines Verification System 11 Mar 2013

Tamper

Evident

Seal


Aggregation

Closing Comments Execution Business Drivers Big Picture Fundamentals Overview

9

» Important to remember that once aggregation is

complete, it must also be maintained and then

broken down as product gets closer to the patient.

1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1

1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1

Case

Unit

Bundle

Pallet

Serialization Types


ePedigree (California)

1

0

Hospital / Pharmacy Manufacturer

Distributor Wholesaler

Product Flow

Serialization Types

Next Steps Plans/Progress Req's Lessons Learned Approach ESP Serialization

Pedigree is built as

product flows through

the supply chain



Serialisation Impact

Enterprise Application (Company Wide)

Site Manager (Site Level)

LEV

EL 4

LEV

EL 3

Line Manager (Line Level)

LEV

EL 2

Device Level

LEV

EL 1

Supplier Manufacturer Distributor Distributor/ Wholesaler

Hospital / Pharmacy

Entire

IT

Arc

hitectu

re Entire Supply Chain

Serialisation

Impacts the Entire

Business


Business

11




Business

12

Protect the patient » Counterfeit product is dangerous!

More efficient recalls » Minimise patient impact

» Minimise financial impact to the company

Brand Protection » Protecting your supply chain is critical in protecting your brand

» If counterfeiters see your supply chain as being weaker than that of

other companies, then they will specifically target your products

Avoid Revenue Loss. » Each counterfeit unit is potentially a unit of lost revenue

Regulatory compliance. » Meeting regulatory requirements will be mandatory




Business

13

Main Markets

» US Market was driven by CA law. This regulation

requires full ePedigree.

» Recent Federal (FDA) Drug Quality and Security Act

(H.R.3204) if signed will supersede CA law.

» Serialisation by Q4 2017

» Aggregation and full traceability by 2023 (FDA to define

mechanism)




Business

14

Main Markets continued

» European requirement based on EFPIA guidelines

(European Federation of Pharmaceutical Industries and

Associations). These require Serialisation with Tamper

Evidence and the use of a Randomised set of

numbers but not full Track & Trace. Approval

expected Q2 2014

» Other markets are tending to go with one or other or a

combination of the above. Korea, Turkey, Saudi

Arabia



The Business (Case) Drivers for

Serialisation

15




Serialisation

16

Counterfeit Medicines – Can YOU Tell the Difference?

FAKE AUTHENTIC

www.EnterpriseSystemPartners.com 17

Counterfeits seized in Beijing

www.EnterpriseSystemPartners.com 18

Not cGMP


• Patient Safety

• Supply Chain Management

• Business Continuity

• Brand Protection



Serialisation

19

Core Business Drivers

SERIALISATION



Optimising Your Serialisation

Investment

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Investment

21

Complexity & Cost of Serialisation

ePedigree

Aggregation

End to End




Investment

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Global Considerations

» Requires global multifunctional

multi-disciplined implementation

team (Including Partners)

» Anticipate and risk assess any expected

changes in regulatory requirements & timelines

» Plan artwork changes early

» Readiness of CMOs & distribution partners




Investment

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Site Considerations

» Agree impact on OEE and

other KPIs at both ramp-up

and steady state

» Plan inventory levels well

in advance to allow for line

installation downtime

» Fail safe design of data capture & management




24




25

It is Vital to Approach Serialisation with a

Strategy which:

» Is not sensitive to subtle changes in

regulations

» Allows for phased execution

» Avoids unnecessary complexity




26

High Level Process Design

» Top down approach

» Clear understanding of market and business

requirements from Pharmacy/Hospital right back

to Packaging Line

» Develop a top level realistic time line

» Clearly understand the business and regulatory

constraints

» Identify, document and clearly communicate the

agreed business process to all stake holders

Requirements




27

Requirements

Typical Plant Level Requirements

» No impact to Pack Line capacities

» Maintain Paperless (MES) operation

» Minimise manual input of data during batch

» Ensure data integrity through out all systems

particularly at Line level

» Obtain Serial Numbers from Corporate server &

manage locally

» Print serial numbers on each shelf unit (child), Case

label (parent), Pallet label (grandparent)




28

Project Team – Cross Functional Across All Departments

» Technology selection

» Vendor selection

» Detailed understanding of timelines

» Functional Design

• Data carrier process

• Line and existing equipment integration

• ERP/MES/EPCIS integration

• Artwork and Label Design/changes




29

Planning

» Do not underestimate;

• the challenge in getting a project of this scope underway

• the complexity of Serialisation

» Availability of key vendors will

inevitably be an issue. Lead-times

are already getting longer

» Vendor management is critical

• Tight timelines

• Diverse vendor set

• Pressure on vendors from other customers




30

Planning (Contd..)

» Plan packaging line downtime. Try to plan pilot

implementation on line with low utilization

» Plan artwork changes early,

these changes require significant

management




31

» Map out the business process across the entire

organization. Involve strategic partners in this

process

» Identify and prioritise countries based on defined

business drivers

Process

» Get clear understanding of

Business Drivers & Constraints

(Ensure this is user driven)




32

» Agree benefits with business owners

» Agree impact on OEE and other KPIs at both ramp-up

and steady state

Process (Contd..)

» Anticipate and risk assess

any expected changes in

regulatory requirements



Standardisation – A Case Study

33

Case Study – Design Challenge

» Develop a flexible serialisation solution for multiple

market requirements across multiple packaging

lines.




34

Design Solution

» Create a standard design solution with the same

equipment and configuration across all packaging

lines

» The solution involves 4 elements at the end of the

packing lines

1. Carton printer and check weigher

2. Semi-automatic case packer

3. Case sealer and case label print and apply

4. Automatic aggregation of manual pallet building




35

1. Carton printer and check weigher.

» Cartons are printed (Lot,

Expiry date and 2D data

matrix)

» Carton print is inspected

» Carton is weighed

» When successful, carton serial

number is commissioned




36

2. Semi-automatic case packer

» Cartons are scanned as they enter case packer

» Cartons are aggregated to the case once case is full.




37

3. Case sealer and case label

print and apply

» Case is sealed

» Case label is applied

» Case label is inspected

» When successful, case

auto commissioned and

aggregated to pallet




38

3. Automatic aggregation of

manual pallet building

» Successful cases are

automatically aggregated

to pallet

» When desired number

cases are aggregated

pallet is closed and a

pallet label is printed

» Pallet is then

commissioned using HHT




39

Design challenges - Design must allow for;

» Manual case packing on two lines

» A fully automatic case packer and automatic

palletiser on one line

» Any line must be capable of running any product

(for flexibility and redundancy)




40

Benefits

» Implementation cost for subsequent lines have

been reduced by ~19%

» Validation effort reduced and standardised with

generic URS, DS, IQ, OQ, PQ doc’s for

subsequent lines. Strict control of “core”

configuration required (no adhoc changes)

» Off line validation of equipment reduced the

downtime requirements of production line

» Same configuration on packaging lines allows all

lines to run the same products




41

Benefits Continued

» Reduced training, spare parts as solution is

generic. Increased operator mobility

» Manual packaging line can be used to complete

testing for system upgrades (off-line) prior to

implementation on all lines




42

Program Status (September 2013)

» 1 line is in production for non-serialised products

» 3 lines are in validation testing

» 2 lines ordered for go-live Q1 2014

» 5 lines scheduled for go-live 2014


Thank You

43

Eamonn O’Mathuna

Manufacturing Systems Consultant m: +353 87 7377545

[email protected]


Europe

Cork – Head Office

Dublin

North America

Boston

San Francisco

mailto:[email protected]






Serialisation in Life Science: Time to Harness the Opportunity€¦ · A Proven Serialisation...

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