Serialisation in Life Science: Time to Harness the Opportunity - - PowerPoint PPT Presentation

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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 6

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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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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)

LEVEL 4 LEVEL 3

Line Manager (Line Level)

LEVEL 2

Device Level

LEVEL 1

Supplier Manufacturer Distributor Distributor/ Wholesaler Hospital / Pharmacy

Entire IT Architecture 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

• ther 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

• ther 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

• rganization. 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 eamonn.omathuna@esp.ie

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Europe Cork – Head Office Dublin North America Boston San Francisco