Serialisation in Life Science: Time to Harness the Opportunity€¦ · A Proven Serialisation...
Transcript of 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
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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
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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
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Enterprise System Partners
A Global Track Record of Success
Medical Device
Pharmaceutical /Biotechnology
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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
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The Impact of Serialisation on
Business
Impact on Business Business Drivers Optimise Investment Strategy Effective Approach
Serialisation isn’t new…
…it has been in industry for decades
1990’s 2000’s 2010’s
Pacemaker
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Impact on Business Business Drivers Optimise Investment Strategy Effective Approach
The Impact of Serialisation on
Business
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» Put a serial number on a box.
» Read it into a database.
» Job Done?
Do We Underestimate Serialisation?
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End to End (European EFPIA Approach)
Closing Comments Execution Business Drivers Big Picture Fundamentals Overview
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Serialization Types
Source : EFPIA European Medicines Verification System 11 Mar 2013
Tamper
Evident
Seal
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Aggregation
Closing Comments Execution Business Drivers Big Picture Fundamentals Overview
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» 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
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ePedigree (California)
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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
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Impact on Business Business Drivers Optimise Investment Strategy Effective Approach
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
The Impact of Serialisation on
Business
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Impact on Business Business Drivers Optimise Investment Strategy Effective Approach
The Impact of Serialisation on
Business
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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
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Impact on Business Business Drivers Optimise Investment Strategy Effective Approach
The Impact of Serialisation on
Business
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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)
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Impact on Business Business Drivers Optimise Investment Strategy Effective Approach
The Impact of Serialisation on
Business
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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
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Impact on Business Business Drivers Optimise Investment Strategy Effective Approach
The Business (Case) Drivers for
Serialisation
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Impact on Business Business Drivers Optimise Investment Strategy Effective Approach
The Business (Case) Drivers for
Serialisation
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Counterfeit Medicines – Can YOU Tell the Difference?
FAKE AUTHENTIC
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Counterfeits seized in Beijing
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Not cGMP
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• Patient Safety
• Supply Chain Management
• Business Continuity
• Brand Protection
Impact on Business Business Drivers Optimise Investment Strategy Effective Approach
The Business (Case) Drivers for
Serialisation
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Core Business Drivers
SERIALISATION
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Impact on Business Business Drivers Optimise Investment Strategy Effective Approach
Optimising Your Serialisation
Investment
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Impact on Business Business Drivers Optimise Investment Strategy Effective Approach
Optimising Your Serialisation
Investment
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Complexity & Cost of Serialisation
ePedigree
Aggregation
End to End
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Impact on Business Business Drivers Optimise Investment Strategy Effective Approach
Optimising Your Serialisation
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
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Impact on Business Business Drivers Optimise Investment Strategy Effective Approach
Optimising Your Serialisation
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
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Impact on Business Business Drivers Optimise Investment Strategy Effective Approach
A Proven Serialisation Strategy
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Impact on Business Business Drivers Optimise Investment Strategy Effective Approach
A Proven Serialisation Strategy
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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
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Impact on Business Business Drivers Optimise Investment Strategy Effective Approach
A Proven Serialisation Strategy
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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
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Impact on Business Business Drivers Optimise Investment Strategy Effective Approach
A Proven Serialisation Strategy
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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)
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Impact on Business Business Drivers Optimise Investment Strategy Effective Approach
A Proven Serialisation Strategy
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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
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Impact on Business Business Drivers Optimise Investment Strategy Effective Approach
A Proven Serialisation Strategy
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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
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Impact on Business Business Drivers Optimise Investment Strategy Effective Approach
A Proven Serialisation Strategy
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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
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Impact on Business Business Drivers Optimise Investment Strategy Effective Approach
A Proven Serialisation Strategy
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» 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)
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Impact on Business Business Drivers Optimise Investment Strategy Effective Approach
A Proven Serialisation Strategy
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» 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
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Impact on Business Business Drivers Optimise Investment Strategy Effective Approach
Standardisation – A Case Study
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Case Study – Design Challenge
» Develop a flexible serialisation solution for multiple
market requirements across multiple packaging
lines.
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Impact on Business Business Drivers Optimise Investment Strategy Effective Approach
Standardisation – A Case Study
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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
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Impact on Business Business Drivers Optimise Investment Strategy Effective Approach
Standardisation – A Case Study
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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
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Impact on Business Business Drivers Optimise Investment Strategy Effective Approach
Standardisation – A Case Study
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2. Semi-automatic case packer
» Cartons are scanned as they enter case packer
» Cartons are aggregated to the case once case is full.
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Impact on Business Business Drivers Optimise Investment Strategy Effective Approach
Standardisation – A Case Study
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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
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Impact on Business Business Drivers Optimise Investment Strategy Effective Approach
Standardisation – A Case Study
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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
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Impact on Business Business Drivers Optimise Investment Strategy Effective Approach
Standardisation – A Case Study
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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)
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Impact on Business Business Drivers Optimise Investment Strategy Effective Approach
Standardisation – A Case Study
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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
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Impact on Business Business Drivers Optimise Investment Strategy Effective Approach
Standardisation – A Case Study
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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
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Impact on Business Business Drivers Optimise Investment Strategy Effective Approach
Standardisation – A Case Study
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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
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Thank You
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Eamonn O’Mathuna
Manufacturing Systems Consultant m: +353 87 7377545
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