serialisation from challenge to success · 2018. 4. 26. · serialisation and engineering projects....

Proprietary & Confidential | Copyright © 2018 Excellis Health Solutions LLC | All Rights Reserved www.excellishealth.com

SerialisationFrom Challenge to Success Ian Haynes

[email protected]

Proprietary & Confidential | Copyright © 2018 Excellis Health Solutions LLC | All Rights Reserved

Page 2

Ian Haynes is an engineer with a proven record of innovation. Ian has a strong record of

working collaboratively within complex organisations, offering strategic insight and analysis leading to creative and innovative solutions.

Ian has an extensive background in the pharmaceutical and fine chemical sectors, including technology road-mapping, new product design & introduction, product security, coding & serialisation and engineering projects.

Ian Haynes

Ian was previously Associate Engineering Director in the Global Engineering Technology groupat AstraZeneca Pharmaceuticals where, alongside other activities, from 2006 he played a key role in AZ’s Pack Coding and Security Features programme. As a result of this work, AstraZeneca achieved a leading position with respect to serialisation and continues to play a key role in this field today.

Since 2012 Ian has been working alongside Christoph Krahenbuhl in 3C Integrity and continues to play a key role in 3C Excellis Europe. 3C’s core business is to support participants in the phama supply chain in shaping up, planning and delivering their serialisation programmes.

Ian’s area of specialist expertise is a solid, practical understanding of these programmes, particularly from the perspective of manufacturing systems design, development and operation.


Page 3

Manuh Pitasari

Ms Manuh Pitasari is a pharmacist with more than 10 yrs working experience in Pharmaceutical Industries.

She is a specialist in Sterile production and has been responsible to introduce new production lines and entire

highly automated new facilities in Indonesia through to successful PIC/s GMP inspections. She has a deep

background in all compliance areas and is a highly practical and customer focused GxP practitioner


Page 4

• Brief Background and Introduction

• Serialisation in Context

• Global Requirements

• Supply Chain Participants and Impacts

• Getting Started – a roadmap to success

• Q & A

Agenda


Page 5

• Brief Background and Introduction• Serialisation in Context




• Q & A

Agenda


Page 8

• Direct Impact on Patient

• No therapeutic benefit

• Over or under dosage

• Harmful effects including death

• Impact on Brand Owners

• Adverse events

• Loss of revenue

• Loss of brand

• Loss of reputation

• Wider Impact

• Loss of efficacy (Malaria drugs, Antibiotics)

Impact of Counterfeit drugs

Patient Safety

Brand Protection


Page 9

Verification of Sales Pack is critical

Counterfeit


Page 10

Pack focused strategies to fight counterfeiting and other threats

Threats

AC Technology

Authentication Features

• Overt

• Covert

• Forensic

Serialisation

Assignment of a unique identity to

each instance of a productTamper Evidence


Page 11

Manufacturer

Commercial Distribution“Retail”

Patients

Legitim

ate

Ille

gitim

ate

Finished

products

Distribution

warehouseDistributors Distributors

Distributors

Hospitals

Pharmacies

Counterfeit

Products Illegal Distributors

Retailers with

no license

“Unwitting”

Patient

Internet Sale

Illegally diverted

products

Stolen products

The “channel”

Counterfeit / illegally traded products can infiltrate the

legitimate supply chain in many potential ways

Export

Rural clinics

Genuine product flow Counterfeit/Illegally traded product flow

Root cause analysis - the supply chain


Page 12

Manufacturer

Commercial Distribution“Retail”

PatientsLe

gitim

ate

Ille

gitim

ate

Finished

products

Distribution

warehouseDistributors Distributors

Distributors

Hospitals

Pharmacies

Counterfeit

Products Illegal Distributors

Retailers with

no license

“Unwitting”

Patient

Internet Sale

Illegally diverted

products

Stolen products

The “channel”

Counterfeit / illegally traded products can infiltrate the

legitimate supply chain in many potential ways

Export

Rural clinics

Genuine product flow Counterfeit/Illegally traded product flow

Need to secure the

supply chain

Root cause analysis - the supply chain


Page 13

BPSSC Strategy

Technology Enforcement Leverage to gain wider business

benefits

Serialisation Other Features

Tamper Evidence Authentication

Collaborate with

stakeholders

Securing the

supply chain

Tactical Compliance Strategic Impact

Must Should Could


Page 14

Illustrations © GS1

Serialisation: The Global Go-To Solution

2010 2017


Page 15

1. Serialisation is critical....but may not be enough!In the event of an incident involving your products, compliance with serialisation regulations may protect you from

regulatory scrutiny – but you are also likely to be subject to public and media scrutiny.

2. Tamper EvidenceTamper evidence of the serialised item is important to give the patient a reasonable degree of assurance that what is

inside the packaging is what the manufacturer intended seems fundamental – securing the product in the secure

supply chain.

Key messages


Page 16

We have just heard about an incident –

sounds serious!

Think the problem product got into the

legitimate supply chain – how?

What steps were taken when building the

legitimate supply chain to ensure it was secure?

16


Page 17

Latest news is that the product was actually manufactured in the

“so called” legitimate supply chain –

what are the ways in which that can happen?

If you find one of your supply chain

partners has been operating

illegally – what will you do to

prevent this happening again?

17


Page 19

Hot off the press!

The pack looks really genuine -but was manufactured by a

counterfeiter

Where did they get their hands on the product – where did they get their

hands on those packaging components? Where did they get their hands on the

machinery to make this stuff?

What steps did you take to prevent this?

19


Page 20


• Serialisation in Context• Global Requirements



• Q & A

Agenda


Page 21

Serialisation in healthcare – A brief history

1997-: Visionary Phase• RFID• The Internet of Things• MIT Auto-ID Center

2003-: Standards Phase• EPC Global (2003)• EPCIS V1 (2007)• Traceability Standard (‘09)

2006-: Pilots / Early Adopters• Merck Serono Serostim (2003)• Pfizer Viagra (2005)• Blood Products Ireland (’06)• BRIDGE (‘06-’09)• EFPIA Sweden Pilot (‘09-’10)• AstraZeneca PSDM (‘08)

2009-: Implementation• Turkey• France CIP-13• California Pedigree• China• Argentina• South Korea• Etc.

A narrowing focus on compliance


Page 23

The Serialised Pack

Pack is assigned and carries a set of attributes e.g.

• Product Code (e.g. GTIN)

• Randomised Unique Serial Number

• Expiry Date

• Batch Number

Attributes combined together into a “code” and presented on the pack in a human readable form and machine readable data carrier e.g. 2D data matrix

Example:

Product #: (01) 0112345678901234

Batch: (10) A1B2C3D4

Expiry: (17) 101112

S/N: (21) 12345AZRQF1234567890


Page 24

The Serialised Pack

Pack is assigned and carries a set of attributes e.g.

• Product Code (e.g. GTIN)

• Randomised Unique Serial Number

• Expiry Date

• Batch Number

Attributes combined together into a “code” and presented on the pack in a human readable form and a machine readable data carrier e.g. 2D data matrix

Example:

Product #: (01) 0112345678901234


Expiry: (17) 101112

S/N: (21) 12345AZRQF1234567890


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Scanning & Application Identifiers (AIs) in action...

01108576740020171714112010NYFUL0121192837 ?0110857674002017 17141120 10NYFUL01 21192837

Sys

tem

Inp

ut GTIN: 09012345670016

EXPIRATION: 21.May 2012

BATCH/LOT: 123456

SERIAL: 123456

20 Nov 2014 NYFUL01 19283710857674002017


Page 26

Pack Hierarchy – Aggregation & data carriers

Item


Page 27

Drivers for coding - Aggregation

Pallet Logistics efficiency Facilitate T&T / ePedigree

Case /Shipper

Logistics efficiency Facilitate T&T / ePedigree

Sales Pack Security, PatientSafety, Anti-fraud

Authentication / Verification; Product Identification / Dispensing errors; e-Health;

PrimaryPackage

Patient Safety, Efficiency

Product Identification / Dispensing errors; e-Health

Single Unit Currently none Possibly Clinical Trials use

Logistics world

Authentication world

Patient safety world


Page 28

Pack Hierarchy – Aggregation & data carriers example


Page 29

1) What is T&T?

Track

Trace

2) Key Enablers

2) Serialised Item Marking

3) Capture Relationships (Aggregation)

4) Link to Business Events (e.g. shipment)

3) Leading to

Information Sharing / Compliance Reporting

What is track and Trace?

1) Standards


Page 30

End to End vs Track and Trace


Page 31

2012

2013

2014

2015

2016

Korea 1

Denmark

Greece

China 1

Japan?

Argentina

Colombia

Canada

India

Export

Brazil 1

India

domestic

Hong

Kong

Taiwan

Russia

Thailand

Coding Requirements

linear or 2D bar

code with batch-

variable data only

(example France

CIP)

Static Product Code

(artwork change

only)

[on primary pack]

2D Datamatrix with

randomised serial

number (and

compliance

reporting of

numbers)

Aggregation

required

Explicit or Implicit

China 2

Regulatory / legal requirement

Commercial / Supply Chain

Roadmap / Standard

Other

Korea 2

Slovenia

Algeria

Denmark

Netherlands

Switzerland

Serbia

Germany

EU-FMD

Unclear/unconfirmed

requirementsSMS

Kenya

ParaguayMexicoPanama

GS1

GS1

GS1

Turkey PTS

US

US (batch)

Korea 3

Saudi 1

Saudi 2

2017 onwards

India

Export

Brazil 2


Page 32

1. Serialisation provides a digital platformWhilst the initial driver may be patient safety – we are building a digital platform that may be exploited by multiple

stakeholders for a range of internal and external benefits – e.g. supply chain efficiency/visibility

2. Standards are an essential enabler!In addition to technology capabilities, interoperable standards are essential in order to drive the broadest benefits

from the programme most quickly.

Key messages


Page 33



• Global Requirements• Supply Chain Participants and Impacts


• Q & A

Agenda


Page 34


Global Requirements – The Challenge

2010 2017


Page 35

80%

2020


Page 36

Radar Operator

Market Watch

Consolidated

view of

Requirements

Coding Assessment Team

Remember:

➢ Subject to Change

➢ Change Management

➢ Version Control

➢ Documenting the Decision

Programme of Work

New and

changing requirements

What we are going to do

Strategy

Technical Assessment

Feasibility

Agreed Principles

Make decision visible, share with

stakeholders

What do these mean?

Impact assessment

Coding Assessment Process


Page 41

Global Pharma sales bn $ 900

US, 350

EU, 280

Asia / Africa /

Australia, 100

Japan, 100LA, 70


Page 42

GTIN (01) 20354482053011

SN (21) xxxxxxxxxxx

Exp (17) YYMMDD

Lot (10) xxxxxxxx

MFG Requirement

*No enforcement when handling product without SNI introduced between Nov 2017 and Nov 2018

*

*

*

*

DSCSA Timeline


Page 43

EUFMD “Point of dispense verification”

Product #: (01) 0112345678901234


Expiry: (17) 101112

S/N: (21) 12345AZRQF1234567890

Upload


Page 44

The Road to EU-FMD Compliance: 9th Feb 2019

2005-2010: Growing awareness of Problem

2011: EU-FMD

2012-2015: Stakeholder Alliance

2016: DR

2016-2019: Implementation

2019: Go Live


Page 46

Substantial amount of information available to

support stakeholders who have obligations under

these requirements

https://emvo-medicines.eu/knowledge-database/

EMVO Knowledge Base

https://emvo-medicines.eu/knowledge-database/


Page 48

A silver lining on the horizon – Emerging Global Standard


Page 49

• Staying close to the emerging global standard allows you to take advantage of the technology solutions and experience gained already in the early adopter markets

• Stepping outside of the standard has the potential to increase risk which may impact the costs, time to deploy and manufacturing impact

• Global standards facilitate international commerce

• Early adopting manufacturers are playing an advocacy role influencing emerging requirements

The Benefits of Adhering to the Emerging Global Standard


Page 50

An example of a non collaborative approachFood & Drug Regulatory Authority in Nigeria, NAFDAC

Industry was not willing to take action,

HA’s imposed a solution

Mobile Authentication Service

Flow Diagram


Page 51

Factors to consider

• What is the risk in your supply chain?

• Re-use of packaging – counterfeit manufacture – theft?

• What are the end points of your “secured” supply chain

• How far do your regs reach - pharmacy – patient?

• What is the true nature of your supply chain

• Who are the participants – what are their capabilities and use cases?

• How do products travel through your supply chain

• Original packaging between end points – re-packaging – partial dispensing?

• National infrastructure?

Is the Emerging Standard Right for You?


Page 52

• Additional factors that should be considered

• The selection of the item

• Tamper Evidence

• Source of serial numbers – codes

• ?

Beyond the Emerging Global Standard...

Product #: (01) 0112345678901234


Expiry: (17) 101112

S/N: (21) 12345AZRQF1234567890


Page 55

Brand

Owner

Serial Numbers – Provisioning

Line Controller

Site Manager

• Line system manager

• Interface to ERP/MES

• Recipe Control

• Download external Serial Number

• Site-level data concentrator / buffer

EPCIS

• Post-line / Post-lot rework

Enterprise Level

• Enterprise-wide EPCIS

• Compliance reporting

• Serial Number Verification access

• Link to Master Data Management

• Link to Sales & Distribution

A

D

CCMO,

3PL

B

E

Internal Serial Number Sources:

C. Central Serial Number Generator

D. Generated at lower ISA-95 levels

E. “Discovered” on line

External Serial Number Sources:

A. Brand Owner

B. Government/External Authority


Page 56

Serial Numbers – Provisioning Practices

A – Increasingly common, driven by QA

typically – a source of complexity

B – Example China – made practical by

de-linking from batch related attributes

C – Almost universal

D – Rare (but smart?)

E – Rare (but smart?)


Page 57

Factors to consider

• Indonesia is a very large and complex market

• Significant diversity is to be expected

• Technological diversity from Jakarta to Papua

• Manufacturing diversity – relatively small number of large manufacturers with extensive capabilities - many small manufacturers with more limited capabilities

• Supply chain diversity

• Solution needs to stretch to be effective right across the market

• Could consider this to be a more demanding requirement than that faced by other markets

Indonesian Requirements?


Page 58

Proposed system has a strong emphasis on securing the supply chain and protecting the consumer from counterfeits through surveillance

• Serialisation/product identification

• Track and Trace

• Consumer participation

Broader ambitions are also apparent

• Optimise recall

• Enhanced surveillance of manufacture, distribution and healthcare service activities

• Prevent shortages

Indonesian Requirements?


Page 59

• Track and Trace

• Optimising production plan

• Visibility of distribution

• Optimising procurement planning

• Visibility of drug consumption in each region

• Preventing shortages

• Optimising recall

• Minimise counterfeit

Anticipated Manufacturer, Distributor and Healthcare Facilities benefits

In other markets (EU for

example) this level of

visibility was hoped for by

the manufacturers but not

achieved.

Loss of data visibility was

the price of participation of

other supply chain actors


Page 60

• Scope includes domestic and imported products – this catches the attention of global manufacturers and standards bodies – inclusion of OTC!

• They are looking for compliance with the de-facto emerging global standard...

• Lobbying to use 2D data matrix and not QR codes

• Lobbying to comply with GS1 standards

• If Indonesia can accommodate these requests whilst at the same time meeting the demanding requirements Indonesia face – it would help the rapid and effective implementation of the system.

The view from outside...


Page 61

• Pack attributes

• Registration number

• Batch number / production code

• Expiration date

• Serial number

• Optional GTIN and other product identities

• Alignment on GTIN as product code is desirable (note GTIN ≠ Registration number...)

• Inclusion of “other product identities” along with use of QR (vs wide healthcare adoption of GS1 data matrix) gives rise to concerns over the physical size of the code.

• Identification of the item...

The view from outside...in a bit more detail

Product #: (01) 0112345678901234


Expiry: (17) 101112

S/N: (21) 12345AZRQF1234567890


Page 63

• The proposed system provides the facility for manufacturers to generate their own serial numbers

• The proposed system also offers to provide 2D codes for manufacturers “without their own serialisation system”

• The inclusion of batch specific data in the codes along with the 2 week lead time may make this problematic to operate

• A complete understanding of the obligations on manufacturers and how these are viewed internally from a GMP perspective is required before it can be understood how this provision will aid manufacturers in practice e.g reconciliation of codes, storage of codes etc.

What is the source of serial numbers?


Page 65

1. There is an emerging de-facto global healthcare coding standard

Alignment with the standard is beneficial for all supply chain participants.

2. There may be specific characteristics of the Indonesian supply chain that demand a non standard approach or non standard components

Protection of Indonesian consumers is more important than compliance with emerging standards

Key Messages


Page 66




• Supply Chain Participants and Impacts• Getting Started – a roadmap to success

• Q & A

Agenda


Page 67

• Regulations clearly state who the supply chain participants are;

• Manufacturers

• Distributors

• Healthcare Facilities

• Consumers

• Regulator is also a participant and plays a vital role playing their part in the design, implementation and running of the system

• Detail assessment of impact not yet possible – subject to publication of final regulation

Supply Chain Participants


Page 68

• The role of the regulator is fundamental

• BPOM have been developing the requirement over a number of years

• 2016 planning

• 2017 scoping, piloting, benchmarking, legal drafting

• 2018 stage 1 implementation....

• Taking feedback from the pilot group and lobbyists and considering/making adjustments to the requirements

• Next phases are critical to the success of the system

• Detail definition and guidance for supply chain participants – technical working groups?

• Support to stakeholders in understanding their obligations under the regulations and GMP

• Being responsive to feedback from stakeholders, providing and communicating, clarification of requirements and obligations

The Regulator


Page 69

Implementation/roll out of the proposed system is a key consideration for the regulator – experience from other markets...

• In addition to publication of the regulation - publication of the “URS Lite” in EU was a fundamental step in facilitating participants understanding of the system and their obligations

• Further more detailed publications followed – software development kit etc allowing solution providers to build and test solutions

• The “real” supply chain may be more complex than the regulations anticipate – multi-role players, virtual manufacturers, re-packaging etc.

• Early engagement with detail flushes out these use cases

• Engagement needs to be facilitated – recommend engagement with industry associations/trade bodies to run technical user groups

• Consideration may be given to phasing in requirements – scope phasing, or technical capabilities – but beware of transitional issues...

The Regulator


Page 70

• The manufacturer is at the heart of this – without the ability to consistently and reliably put readable codes on packs – the system can not run

• Experience across multiple companies setting out to achieve compliance with various serialisation requirements indicates that this is likely to be the biggest and most complex programme you will deal with.

• And it may not always be plain sailing...

The Manufacturer

There is a lot if information now on manufacturing impact

Key initiatives have focussed here

• US stepwise implementation

• EU End points only

Other supply chain impacts are only now emerging


Page 71

This is not just a technology project

Master Data Mgt., GTINs

etc.Radar & Impact

Assessment

External Alignment

Investigations & Enforcement

Incident Management

Supply Chain Integrity

Artwork Process

Regulatory Function

System Security Concerns

System Validation/GAMP

etc.

Distribution

Enterprise level

Site Manager

Line Control

Device

Leve

l 1Le

vel 2

Leve

l 3Le

vel 4

Collaboration Layer

Scanner PrinterScannerCameraPrinter RFID

HMI Packing Line

Repository

Capture I/F

Query I/FNumber Mgt.

Master data

Authentication

Compliance module

WMS

Packaging

http://www.google.co.uk/url?sa=i&rct=j&q=bar+code+scanner&source=images&cd=&cad=rja&docid=fU8l7fDKWKDxyM&tbnid=ZUn2eCCgN46FHM:&ved=0CAUQjRw&url=http://www.ebay.com/itm/New-USB-Barcode-Scanner-Laser-Bar-Code-Reader-POS-Cash-Register-2-M-Cable-/271078296611&ei=Mm43UYmcC8q20QW_pIDICw&bvm=bv.43287494,d.ZWU&psig=AFQjCNEFM9T-8TOGEghRacIaHGJYg0dk1w&ust=1362673578470256http://www.google.co.uk/url?sa=i&rct=j&q=bar+code+scanner&source=images&cd=&cad=rja&docid=fU8l7fDKWKDxyM&tbnid=ZUn2eCCgN46FHM:&ved=0CAUQjRw&url=http://www.ebay.com/itm/New-USB-Barcode-Scanner-Laser-Bar-Code-Reader-POS-Cash-Register-2-M-Cable-/271078296611&ei=Mm43UYmcC8q20QW_pIDICw&bvm=bv.43287494,d.ZWU&psig=AFQjCNEFM9T-8TOGEghRacIaHGJYg0dk1w&ust=1362673578470256http://www.google.co.uk/url?sa=i&rct=j&q=lable+printer&source=images&cd=&docid=3OaEJBDRsFr5SM&tbnid=10a9XMFIpL8O7M:&ved=0CAUQjRw&url=http://www.accuratesystemslabelling.co.uk/information/buyers-guide/detail/id=9&ei=hG43UfW8AcbB0QX_9oGQCQ&bvm=bv.43287494,d.ZWU&psig=AFQjCNFU7QKnKwT18uwr0YQou7LVSVhhUg&ust=1362673650452914http://www.google.co.uk/url?sa=i&rct=j&q=thermal+ink+jet&source=images&cd=&cad=rja&docid=IdcO_XfYu6riWM&tbnid=vtyZK4xnXtn0SM:&ved=0CAUQjRw&url=http://www.packagingdigest.com/article/455659-Thermal_ink_jet_printer.php&ei=BG83UcP6N6e_0QW2v4DgCA&psig=AFQjCNGpgbsx-qxnIUyUDt3hQf8Iml0pEA&ust=1362673772833033http://www.google.co.uk/url?sa=i&rct=j&q=machine+vision+system&source=images&cd=&cad=rja&docid=TG-W3Y2UeOcuwM&tbnid=s8dbLn60xf1SoM:&ved=0CAUQjRw&url=http://www.directindustry.com/prod/turck/cameras-for-machine-vision-systems-4959-565263.html&ei=dG83UZqLLoy20QW-s4GwCA&psig=AFQjCNHsacjT8QmYUabtgJnQUNCfwXN8Dg&ust=1362673867147348http://www.google.co.uk/url?sa=i&rct=j&q=rfid+reader&source=images&cd=&cad=rja&docid=DrcPH2mKJApNKM&tbnid=G4c2a4JQVHT6yM:&ved=0CAUQjRw&url=http://friendcom.en.alibaba.com/product/260184899-200093002/FC_406_Active_RFID_Reader.html&ei=bXA3Uc6nC7SU0QW59IDwBw&psig=AFQjCNEXb8anK5lUgi4AILcrtzW9gKG56Q&ust=1362674145772787http://www.google.co.uk/url?sa=i&rct=j&q=hmi&source=images&cd=&cad=rja&docid=QyDdcpn7uQ6_pM&tbnid=riojxCoTHYe7eM:&ved=0CAUQjRw&url=http://www.transdrive.co.uk/hmi/delta/&ei=2XA3UfKECeWd0QXEtYH4Bw&psig=AFQjCNGUHM6GeyZ4zoO4-LGSh_XKA8AlBA&ust=1362674243062950http://www.google.co.uk/url?sa=i&rct=j&q=computer&source=images&cd=&cad=rja&docid=BliXwZtvhrONRM&tbnid=4LD4vNRi1acYyM:&ved=0CAUQjRw&url=http://www.cantleycomputers.co.uk/Repairs.html&ei=_3E3UbiKLcit0QWT5oGICQ&psig=AFQjCNG2fTuwxjRI4POZObyfot1Qj-1HhA&ust=1362674552598850http://www.google.co.uk/url?sa=i&rct=j&q=pallet&source=images&cd=&cad=rja&docid=-iFPJRKvAwSlrM&tbnid=sQDIFsqdb_TdfM:&ved=0CAUQjRw&url=http://www.storageconcepts.co.uk/blog/2012/06/08/pallet-racking-recent-project-leicester/&ei=SXI3UZj1J4a90QXG_4DgBw&psig=AFQjCNHPdF-zIGdHUWA3GvmacBlMSdF64Q&ust=1362674623798087http://www.google.co.uk/url?sa=i&rct=j&q=pallet&source=images&cd=&docid=PQ0P5OOsLCX8YM&tbnid=yse15GHI3LnDUM:&ved=0CAUQjRw&url=http://dunhilltimberpallets.com/&ei=pnI3UevhDsOn0AWUroCgCQ&psig=AFQjCNHPdF-zIGdHUWA3GvmacBlMSdF64Q&ust=1362674623798087


Page 73

The Serialisation Solution Stack

DistributionPackaging

Enterprise level

Site Manager

Line Manager

Station Manager

Level 1Production Control (manipulating)

Level 2Production Control

(supervisory)

Level 3Manufacturing Operations Management

Level 4Business Logistics

Collaboration Layer

Scanner PrinterScannerCameraPrinter RFID reader

HMI Packing Line

RepositoryCapture I/F

Query I/FNumber management

Master data

Authentication services

Compliance module

WMS

Level 5



Page 74

The Serialisation Solution Stack Components

DistributionPackaging

Enterprise level

Site Manager

Line Manager

Station Manager

Level 1Production Control (manipulating)

Level 2Production Control

(supervisory)

Level 3Manufacturing Operations Management

Level 4Business Logistics

Collaboration Layer

Scanner PrinterScannerCameraPrinter RFID reader

HMI Packing Line

RepositoryCapture I/F

Query I/FNumber management

Master data

Authentication services

Compliance module

WMS



Page 75

The Hardware

Starting from the base line of a conventional manufacturing line with no tamper evidence and embossed variable data …….what would the item level coding station look like?

• A platform (maybe a tamper evident labeller)

• Addressable printer with associated vision system

• Integrated reject station

• Level 2 serialisation software component – connected to level 3

Aggregation – additional hardware integrated into existing equipment or semi-automatic coding and printing equipment.


Page 77

Manufacturing Impact

Top Tier

Average

Poor

Performer

Top tier line – a small but permanent drop in OEE – 5%

Average line – significant early drop in OEE followed by recovery and the

prospect of improved performance in the long term

Poor performer – rapid decline in performance – little chance of recovery

Early adopters report

significant impact - 2 to 4

years required to recover

OEE!

Manufacturing NEWS


Page 78

• Enemy of serialisation is disturbance from the steady state

• Take time under normal circumstances but serialisation increases the complexity of recovery – reconciliation of the physical and data assets

• Work on the performance of your assets now;

• Drive ERT (Effective Run Time) up

• Consider reinvestment where assets are poor performers

• Create capacity now

What Can You Do Now?

Primary Packing Secondary Packing

ERT >

60%

35% < ERT < 60%

ERT <

35%

ERT >

60%

ERT <

60%

Retain

Sustain

Drive

Arrive

Retire

Aspire

Retire

Aspire

Retain

Bolt on

70%

30%

Capex

Pick your Pilot Line...• Not your best

• Not your worst

• Not your most occupied

• Not your most important

product

• Pick your pilot team


Page 79

• Like other supply chain participants there is a need to map your current business processes and to overlay on those your obligations under the new regulations – note 2025 deadline...

• “Happy Path” requirements appear to be relatively straightforward

• Scan product in and report to BPOM – note scan down through the aggregated levels until scan is valid – tertiary, secondary, item

• Scan the product out and report to BPOM

• Full process mapping however is required to identify all your business processes and understand how they are impacted e.g.

• Sampling, loss or damage, no reads

• Partial shipments

• Export (sales to anyone outside of the system)

• Repackaging

• Integration with existing business systems e.g. WMS

The Distributor


Page 80

Factors to consider

• Manufacturers use of 3PL – handle product on their behalf

• Wholesaler – receive product from manufacturer but also from other wholesalers

• Wholesalers may reconfigure product for onward shipment

• Aggregations established by the manufacturer may not survive very long in the supply chain

• Wholesalers will be de-aggregating and re-aggregating product

• Mixed (non homogeneous) cases and mixed pallets will move around the supply chain

• Reverse logistics

The Distributor

3PL

NB. Current coding

scheme may not

support

reconfiguration of

goods in the supply

chain – default

option is item level

scanning


Page 81

• May see variety in codes on incoming goods

• QR Codes

• 2D DM codes

• Codes on secondary and tertiary packaging?

• Status of product now becomes important and this may need to be reflected in physical disposition of the goods in facility

• Ready to scan (incoming goods)

• Scanned and failed (synchronous or asynchronous process?) – quarantined for return

• Scanned and available

• Scanned and ready to ship

• In addition to (mobile) scanning equipment, likely to need some technology, possibly integrated with current WMS and ERP systems recording and aligning product status

The Distributor


Page 82

• Healthcare facilities are very similar to distribution facilities in the regulation – the final transaction however is an item level “sell” rather than “ready to be distributed”

• Similar considerations apply for healthcare facility

• May see variety in codes on incoming goods

• QR Codes

• 2D DM codes

• Codes on secondary and tertiary packaging?

• Status of product wrt to the system now becomes important and this may need to be reflected in physical disposition of the goods in facility

• Ready to scan (incoming goods)

• Scanned and failed (synchronous or asynchronous process?) – quarantined for return

• Scanned and available

• Scanned and ready to sell/dispense

• In addition to scanning equipment, likely to need some technology, possibly integrated with current PMR or POS systems recording and aligning product status

Healthcare Facilities (Hospital pharmacy, drugstore, dispensary)


Page 83

• Although provided with an app to allow consumers to validate their own product, they are not system participants as such but simply gain access to the status of the product (serial number)

• Expectation is that consumers will

• Verify their product

• Report suspected counterfeits

• Example Europe – scanning at the point of dispensing

• In some clinical settings this may not be possible – parenteral products for example

• May not always be a pharmacist present at point of dispensing – institutional use, dispensing doctors etc

• Take up of such systems of often low – trust in supply chain – privacy issues are increasingly a factor

Consumers


Page 84

• This is a critical moment in the project where the all supply chain participants need to work together to put the meat on the bones of the regulation

• Publication of detail requirements – URS Lite etc

• Business process mapping to understand obligations (happy path and deviations)

• Working together to drive out the detail – industry associations and trade bodies working together with the regulator

Key Messages


Page 85





• Getting Started – a roadmap to success• Q & A

Agenda


Page 86

Some good news and some bad news

• The Bad News:

• Serialisation projects are big projects

• The impact of failure is potentially huge

• Often complex, involving many areas and requiring collaboration across boundaries

• They can suffer from high degrees of uncertainty and change


Page 87

• The Bad News:

• Serialisation projects are big projects

• The impact of failure is potentially huge

• Often complex, involving many areas and requiring collaboration across boundaries

• They can suffer from high degrees of uncertainty and change

• But there is Good News:

• The core capabilities that need to be established are not too complex and increasingly well understood

• These can actually be pretty straightforward projects in terms of planning

• But need to seize the opportunities to simplify: Decouple, use generic approaches that are flexible and adaptable

• With sound programme/project management practice success is assured

Some good news and some bad news


Page 88

Inherent Conflicts

• Serialisation Projects are prone to more conflicts than other projects because of:

• Size and Scale of the undertaking

• Diverse parts of the organisation with diverse standards, guidelines, processes and “traditions” collide

• Operating to different (conflicting?) targets and objectives

• In terms of project management: You are dealing with an IT project but also an engineering project, an artwork project, a supply chain project, business change project etc….


Page 89

• There is a need to map your current business processes and to overlay on those your obligations under the new regulations

• “Happy Path” requirements – make product, apply codes, upload codes to activate the product.

• Non happy path processes need also to be understood e.g.

• Codes requested and not used on finished goods

• Insufficient codes available during manufacturing order

• Post lot re-work - Loss, damage or sampling of product

• Partial case upload

• A consideration of how the serialisation process integrates with your existing business systems will also be required – ERP, MWS etc

• You will need to take a GMP view of your activities under the new regulations – e.g. reconciliation of codes, vision inspection of codes, linking to product release processes, data retention etc.

Business process mapping


Page 90

• Work can start now on a business impact assessment of serialisation

• Aspects like artwork modification to accommodate the new codes are complex and time consuming –may be the biggest artwork project you have undertaken

• Regulatory impact of pack re-design is likely to be a factor – early planning is essential

• Identification of the wider supply chain impact is important as your ability to comply may be critically dependent on the activities of third parties

• Understanding the scope will allow you to resource the project – manpower and finance - avoiding surprises later

• Roll out strategy is important along with any stock build to create capacity

• The initial obligation to get one line operating is critical

• This pilot line forms a technology platform that you can use to establish the capability and the necessary supplier relationships. A solid launch platform to rapid and trouble free compliance.

Impact Assessment


Page 91

You need the right team


Page 92

Research lists the following suspects:

• Supply chain management

• Product Security Function

• Production/Manufacturing Ops.

• IT

• Packaging

• Regulatory

So who should lead the team?

Questions:

• Where does the program emerge from?

• Where is the program best placed for

now?

• Who will own this long-term in BAU?

• Who will suffer most if it goes wrong?


Page 93

• Regulatory• IT• Package Design/Labelling• Package engineering• Warehouse• Distribution• QA• Validation and CSV• Operations• Planning and scheduling• Supply chain and logistics• Customer services/commercial• Sourcing/Procurement

• Legal• Any others?

Who should be in the team?


Page 94

• What are the characteristics of your supply chain up to the point of “change in title”?

• Your supply chain reaches beyond your packing line, factory and organisation!

• Are you a 3PL or a wholesaler or both?

• Where is the centre of gravity of your project?

Where are you in the supply chain?


Page 97

What Goes Wrong?

Your ProgrammeThe Regulatory

Requirements


Page 98

What Goes Wrong - Engaging your Senior Stakeholders


Page 99

What Goes Wrong - Engaging your Senior Stakeholders

What does it Cost (money, resources, attention)? What else does it prevent me from

doing?

How does it impact my OEE? During

implementation and beyond?

What can I do to minimise the impact?

Are there ways of turning this into a benefit?

Do I really need to do anything? Where do I find out more?

What is this all about? What are

these requirements?

"Can we get back to talking about the real

pharmaceutical business now?"


Page 100

Patient Journey = Program Journey

New opportunities


Page 101

• Conflicting priorities

• Misunderstanding the scale and scope of the programme

• Underestimating resource requirement – people, capital, capacity, time

• Master data management problems

• Lack of strategic clarity

• Failing to address the external supply chain in time

• Poor/limited regulatory understanding

• Unknown unknowns...

1

0

1

What Else Goes Wrong…


Page 102

• Poor/limited understanding of the real supply chain

• Timescales for implementation

• Big bang

• Phased roll out - roadmap

• Long vs short lead times

• Too many stakeholders under one umbrella

• Changing direction

• China, India export, Brazil,

• Over ambition – selection of novel solutions

• Failure to pilot to shake issues out

1

0

2

What Else Goes Wrong…Regulatory Issues


Page 103






• Q & A

Agenda


Page 104

Ian Haynes

[email protected]


Page 105

1

0

5


Page 106

• Background and Introduction



• Impact on Manufacturers


• Want you want from your regulator – panel discussion

Agenda


Page 107

• Dialogue – a partnership approach to delivering patient safety through securing the supply chain leading to...

• Regulations• Effective - designed to tackle the identified risks

• Comprehensive – address the activities of all supply chain participants

• Achievable – clearly defined with realistic time phasing

• To as great an extent as possible aligning with the emerging global standard

• Allows available and proven technology solutions to be exploited

• Reduces risk – rapid deployment and predictable cost

• Builds on the experience of others

• Facilitates the creation of capability that is useful in the wider context supporting industry ambition


Page 108


Serialisation: From Success to Challenge

2010 2017


Page 109

Regulatory LabellingManufacturi

ngCMOs IT ERP

Supply chain

sales

• Serialization is a regulatory imperative • Serialization is still evolving . ( Today : Turkey, Korea, US-DSCSA-EUFMD , many new

regulations to come Russia, Middle-East, some regulations changes : Brazil, China, India,….)

• Your company is evolving• Serialisation is an enterprise program

A Holistic approach to serialization


Page 110

• Limited internal bandwidth…: implementing a major project like serialisation that

touches many parts of the organisation

• Limited internal knowledge….: limited internal knowledge and experience of the

particular challenges of serialisation

• How to understand the details and impact of the requirements in the many

markets where the company operates

• Understanding what needs to be done to be Serialisation-ready: Best Practices

Serialisation Project Challenges

Unknown UnknownsPharma Business vs. One-off

ProjectsScope Reaches Far Beyond

Company Border


Page 111

Methodology : Strategy to Sustainability

STRATEGY PILOT STANDARDIZATION INTEGRATION ROLLOUT SUSTAINABILITY

• Process design • Data standards development• Compliance assessment• Technology selection• Pilot implementation

• Integration framework development

• Up-stream & Downstream process integration• Data integration

• Process re-evaluation & standardization• Data standardization• Governance model development• Implementation Template development• Quality framework development• KPI Establishment

• Global solution deployment

• Template localization• Site implementations• Site KPI establishment

• Serialization COE• Internal support model• Best-in-class solution• KPI measurement and

enhancement• Quality management


Page 112

Counterfeit medicines are deliberately and fraudulently mislabelled with respect

to identity or source:

• One of the biggest risks of counterfeit medicines is that patients may not get the therapeutic benefit expected from the product.

• The market in counterfeit and substandard drugs thrives in areas with weak regulation and enforcement of drug laws

• Their victims are the weakest in society: People who are suffering from sickness and illness

• They target areas such as lifestyle applications, nutritional supplements

• Counterfeit medicines are manufactured in clandestine laboratories with no standards, no regard for quality, no control.

• Their quality is unpredictable as they may contain the wrong amount of active ingredients, wrong ingredients or no active ingredients.

Focus on Counterfeit Medicines?


Page 113

Counterfeit Medication – a closer look

Authentic Counterfeit


Page 114

oftware?

Fake Credit Cards?

Narcotics?

ecisions, decision

s...

Counterfeit Pharmaceutical

s?


Page 115

For every $1000 invested, counterfeitpharmaceuticals generates $ ½ Million return*

Pharmaceutical Counterfeiting is seen as High

Profit with Low Risk

So who may be involved ?

➢ Organised crime gangs

➢ Unlicensed businesses

➢ Licensed businesses: Brokers, Distributors,

WholesalersReturn on $1K Investment

$7K

$100K

$500K

Fake c

redit

card

s

Counte

rfeit s

oftw

are

Counte

rfeit d

rugs

* S

ou

rce

: V

isa

/Ma

ste

r C

ard

, M

icro

so

ft,

AZ

ow

n d

ata


Page 116

• Impacting lifestyle drugs

• Branded medicines

• Generics

• High value

• Low value

• High volume

• Low volume

• Internet pharmacy a particular problem

A Global Problem


Page 117

How do you turn all these requirements and uncertainties into something practical that we can deliver?

1

1

7

Impact on Manufacturing


Page 119

Program Organisation

The real skill is to build the right sub-

teams and to manage them when they

are in and also when they are out

Responsible

Accountable

Consulted

Informed


Page 120

Program Organisation

Core Team

Sub team 1 Sub team 2 Sub team 3

Reference or stakeholder

group

Design Authority

Steering Group


Page 121

Implementation ProgrammeACTIVE PROJECTS

Tactics & Strategy

Technical/IS

Delivery SupportProduct Driven

MarketDriven

Security

Features

ProjectOffice

Feasibility/Position

development

Active Implementation Project PDCA

Risk Register CommunicationsCapital & ResourcePlanning

Components

RadarStrategyStrategic

suppliers and identify

feasibilities

List of agreed feasibility and

position statements

A full list of active projects and initiatives will be developed

Pack Coding and Security Features Programme


Page 122

Implementation Programme

ACTIVE PROJECTS

Tactics & Strategy

Development

Technical/IS

Delivery Support

IS System Process

Establishment

Equipment Processes

and Systems

Product

Driven

Market

Driven

Data & Intelligence/Market

Requirements/Technology

Security

Features

Printing on labels &

shrink sleeving Product A

Product C

IV’s Strategy

France

Turkey Aggregation

Feasibility/

Position

development

Tactics & Strategy

Priority Products I

Brazil

SF Database

Components

XX Supply Chain

Established

Product D

Product E

Contractor Pilot

Global GTIN Proceses

HUD Position

Statement

Semiotics Research/

Overt Feature of Choice/PF2

Sweden

PSDM Strategy

RFID gap

analysis/feasibility

High Speed Line

Resp & polyamp

feasibility.

EU Gap Analysis/US

Strategy

China

Denmark

South Korea

Argentina

Hong Kong

EU, Switzerland,

Netherlands and

Spain

Product F

SF Review

Serialisation and Coding

Principles

Includes Market Access

Support Tools Exploitation

Product B - India

Embed Supplier

Partnership Principles Tertiary Pack TE

VialsProduct G

Develop Processes

Team members

Pack Coding and Security Features Programme


Page 123

Who FrequencyWhat

Security Council Quarterly meetingStrategy sign-off

Product Security Strategy Team Monthly MeetingStrategy

development/enh

ancements

Tactics Team

Global Implementation Team

Monthly Meeting

Monthly Meeting

Tactics/Global

Implementation &

Support

Security Regional Contact Meeting 6 weekly meeting

Global Site

/Regional Tactics

&

Communications

Regional/Site Leadershiptba by Global

site/Regional lead

Communications

/Implementation

Site Implementation Team(s)tba by Site Team

LeadersImplementation

Leader

VP Supply Chain

Head of Product

Security

Programme Lead

Regional Product

Security Lead and

Regional

Champions

Global

Site/Regional

Champions

Nominated by

Global

Site/Regional

Champions

Governance and Reporting


Page 124

Excellis Methodology : Strategy to Sustainability

STRATEGY PILOT STANDARDIZATION INTEGRATION ROLLOUT SUSTAINABILITY

• Process design • Data standards development• Compliance assessment• Technology selection• Pilot implementation

• Integration framework development

• Up-stream & Downstream process integration• Data integration

• Process re-evaluation & standardization• Data standardization• Governance model development• Implementation Template development• Quality framework development• KPI Establishment

• Global solution deployment

• Template localization• Site implementations• Site KPI establishment

• Serialization COE• Internal support model• Best-in-class solution• KPI measurement and

enhancement• Quality management


Page 125

▪ Understand the clients’ business model, technologies and capabilities to develop a Strategy for

compliance with serialization regulations in a timely fashion

▪ Deliver a Pilot phase to minimize project risk and ensure the solutions and processes being

implemented are based on best practices

▪ Standardization of the solutions and processes based on Pilot success to be rolled out to the other sites,

lines and business units.  

▪ Integration with both internal and external supply chain partners based on a standardized integration

framework to minimize risk

▪ The solution is then rolled-out to additional lines and sites requiring the capability to meet serialization

requirements

▪ Development of a Serialization Center of Excellence to ensure long term Sustainability

Excellis Project Delivery Methodology


Page 126

Serialisation As-Is Review1. Strategy• strategic initiatives • current shape of the programme

• critical elements and company topology

2. Solution Implementation• existing systems architecture • capability• process design • organization governance

3. Internal Logistics• internal logistics • warehouse• distribution systems

4. Partner Integration• CMOs • External Logistics / 3PLs

5. Coding and Master Data• pack range • labelling• coding • master data• artwork • other security features

6. Technology Stack• serial number management • edge systems• line engineering • repository / EPCIS• site level • systems integration

7. Validation / Quality

8. Programme Management

• project management • change management

• risk management

|---------- As-Is---------- |

Strategy

Partner Integrati

on

Solution Implementation

Internal Logistics

Coding &

Master Data

Technology

Stack

Validation &

Quality

Programme

Management


Page 127

serialisation from challenge to success · 2018. 4. 26. · serialisation and engineering projects....

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