serialisation from challenge to success · 2018. 4. 26. · serialisation and engineering projects....
TRANSCRIPT
-
Proprietary & Confidential | Copyright © 2018 Excellis Health Solutions LLC | All Rights Reserved www.excellishealth.com
SerialisationFrom Challenge to Success Ian Haynes
-
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.
-
Proprietary & Confidential | Copyright © 2018 Excellis Health Solutions LLC | All Rights Reserved
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
-
Proprietary & Confidential | Copyright © 2018 Excellis Health Solutions LLC | All Rights Reserved
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
-
Proprietary & Confidential | Copyright © 2018 Excellis Health Solutions LLC | All Rights Reserved
Page 5
• Brief Background and Introduction• Serialisation in Context
• Global Requirements
• Supply Chain Participants and Impacts
• Getting Started – a roadmap to success
• Q & A
Agenda
-
Proprietary & Confidential | Copyright © 2018 Excellis Health Solutions LLC | All Rights Reserved
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
-
Proprietary & Confidential | Copyright © 2018 Excellis Health Solutions LLC | All Rights Reserved
Page 9
Verification of Sales Pack is critical
Counterfeit
-
Proprietary & Confidential | Copyright © 2018 Excellis Health Solutions LLC | All Rights Reserved
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
-
Proprietary & Confidential | Copyright © 2018 Excellis Health Solutions LLC | All Rights Reserved
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
-
Proprietary & Confidential | Copyright © 2018 Excellis Health Solutions LLC | All Rights Reserved
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
-
Proprietary & Confidential | Copyright © 2018 Excellis Health Solutions LLC | All Rights Reserved
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
-
Proprietary & Confidential | Copyright © 2018 Excellis Health Solutions LLC | All Rights Reserved
Page 14
Illustrations © GS1
Serialisation: The Global Go-To Solution
2010 2017
-
Proprietary & Confidential | Copyright © 2018 Excellis Health Solutions LLC | All Rights Reserved
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
-
Proprietary & Confidential | Copyright © 2018 Excellis Health Solutions LLC | All Rights Reserved
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
-
Proprietary & Confidential | Copyright © 2018 Excellis Health Solutions LLC | All Rights Reserved
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
-
Proprietary & Confidential | Copyright © 2018 Excellis Health Solutions LLC | All Rights Reserved
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
-
Proprietary & Confidential | Copyright © 2018 Excellis Health Solutions LLC | All Rights Reserved
Page 20
• Brief Background and Introduction
• Serialisation in Context• Global Requirements
• Supply Chain Participants and Impacts
• Getting Started – a roadmap to success
• Q & A
Agenda
-
Proprietary & Confidential | Copyright © 2018 Excellis Health Solutions LLC | All Rights Reserved
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
-
Proprietary & Confidential | Copyright © 2018 Excellis Health Solutions LLC | All Rights Reserved
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
-
Proprietary & Confidential | Copyright © 2018 Excellis Health Solutions LLC | All Rights Reserved
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
Batch: (10) A1B2C3D4
Expiry: (17) 101112
S/N: (21) 12345AZRQF1234567890
-
Proprietary & Confidential | Copyright © 2018 Excellis Health Solutions LLC | All Rights Reserved
Page 25
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
-
Proprietary & Confidential | Copyright © 2018 Excellis Health Solutions LLC | All Rights Reserved
Page 26
Pack Hierarchy – Aggregation & data carriers
Item
-
Proprietary & Confidential | Copyright © 2018 Excellis Health Solutions LLC | All Rights Reserved
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
-
Proprietary & Confidential | Copyright © 2018 Excellis Health Solutions LLC | All Rights Reserved
Page 28
Pack Hierarchy – Aggregation & data carriers example
-
Proprietary & Confidential | Copyright © 2018 Excellis Health Solutions LLC | All Rights Reserved
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
-
Proprietary & Confidential | Copyright © 2018 Excellis Health Solutions LLC | All Rights Reserved
Page 30
End to End vs Track and Trace
-
Proprietary & Confidential | Copyright © 2018 Excellis Health Solutions LLC | All Rights Reserved
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
-
Proprietary & Confidential | Copyright © 2018 Excellis Health Solutions LLC | All Rights Reserved
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
-
Proprietary & Confidential | Copyright © 2018 Excellis Health Solutions LLC | All Rights Reserved
Page 33
• Brief Background and Introduction
• Serialisation in Context
• Global Requirements• Supply Chain Participants and Impacts
• Getting Started – a roadmap to success
• Q & A
Agenda
-
Proprietary & Confidential | Copyright © 2018 Excellis Health Solutions LLC | All Rights Reserved
Page 34
Illustrations © GS1
Global Requirements – The Challenge
2010 2017
-
Proprietary & Confidential | Copyright © 2018 Excellis Health Solutions LLC | All Rights Reserved
Page 35
80%
2020
-
Proprietary & Confidential | Copyright © 2018 Excellis Health Solutions LLC | All Rights Reserved
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
-
Proprietary & Confidential | Copyright © 2018 Excellis Health Solutions LLC | All Rights Reserved
Page 41
Global Pharma sales bn $ 900
US, 350
EU, 280
Asia / Africa /
Australia, 100
Japan, 100LA, 70
-
Proprietary & Confidential | Copyright © 2018 Excellis Health Solutions LLC | All Rights Reserved
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
-
Proprietary & Confidential | Copyright © 2018 Excellis Health Solutions LLC | All Rights Reserved
Page 43
EUFMD “Point of dispense verification”
Product #: (01) 0112345678901234
Batch: (10) A1B2C3D4
Expiry: (17) 101112
S/N: (21) 12345AZRQF1234567890
Upload
-
Proprietary & Confidential | Copyright © 2018 Excellis Health Solutions LLC | All Rights Reserved
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
-
Proprietary & Confidential | Copyright © 2018 Excellis Health Solutions LLC | All Rights Reserved
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/
-
Proprietary & Confidential | Copyright © 2018 Excellis Health Solutions LLC | All Rights Reserved
Page 48
A silver lining on the horizon – Emerging Global Standard
-
Proprietary & Confidential | Copyright © 2018 Excellis Health Solutions LLC | All Rights Reserved
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
-
Proprietary & Confidential | Copyright © 2018 Excellis Health Solutions LLC | All Rights Reserved
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
-
Proprietary & Confidential | Copyright © 2018 Excellis Health Solutions LLC | All Rights Reserved
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?
-
Proprietary & Confidential | Copyright © 2018 Excellis Health Solutions LLC | All Rights Reserved
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
Batch: (10) A1B2C3D4
Expiry: (17) 101112
S/N: (21) 12345AZRQF1234567890
-
Proprietary & Confidential | Copyright © 2018 Excellis Health Solutions LLC | All Rights Reserved
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
-
Proprietary & Confidential | Copyright © 2018 Excellis Health Solutions LLC | All Rights Reserved
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?)
-
Proprietary & Confidential | Copyright © 2018 Excellis Health Solutions LLC | All Rights Reserved
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?
-
Proprietary & Confidential | Copyright © 2018 Excellis Health Solutions LLC | All Rights Reserved
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?
-
Proprietary & Confidential | Copyright © 2018 Excellis Health Solutions LLC | All Rights Reserved
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
-
Proprietary & Confidential | Copyright © 2018 Excellis Health Solutions LLC | All Rights Reserved
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...
-
Proprietary & Confidential | Copyright © 2018 Excellis Health Solutions LLC | All Rights Reserved
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
Batch: (10) A1B2C3D4
Expiry: (17) 101112
S/N: (21) 12345AZRQF1234567890
-
Proprietary & Confidential | Copyright © 2018 Excellis Health Solutions LLC | All Rights Reserved
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?
-
Proprietary & Confidential | Copyright © 2018 Excellis Health Solutions LLC | All Rights Reserved
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
-
Proprietary & Confidential | Copyright © 2018 Excellis Health Solutions LLC | All Rights Reserved
Page 66
• Brief Background and Introduction
• Serialisation in Context
• Global Requirements
• Supply Chain Participants and Impacts• Getting Started – a roadmap to success
• Q & A
Agenda
-
Proprietary & Confidential | Copyright © 2018 Excellis Health Solutions LLC | All Rights Reserved
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
-
Proprietary & Confidential | Copyright © 2018 Excellis Health Solutions LLC | All Rights Reserved
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
-
Proprietary & Confidential | Copyright © 2018 Excellis Health Solutions LLC | All Rights Reserved
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
-
Proprietary & Confidential | Copyright © 2018 Excellis Health Solutions LLC | All Rights Reserved
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
-
Proprietary & Confidential | Copyright © 2018 Excellis Health Solutions LLC | All Rights Reserved
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
-
Proprietary & Confidential | Copyright © 2018 Excellis Health Solutions LLC | All Rights Reserved
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
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
-
Proprietary & Confidential | Copyright © 2018 Excellis Health Solutions LLC | All Rights Reserved
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
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
-
Proprietary & Confidential | Copyright © 2018 Excellis Health Solutions LLC | All Rights Reserved
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.
-
Proprietary & Confidential | Copyright © 2018 Excellis Health Solutions LLC | All Rights Reserved
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
-
Proprietary & Confidential | Copyright © 2018 Excellis Health Solutions LLC | All Rights Reserved
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
-
Proprietary & Confidential | Copyright © 2018 Excellis Health Solutions LLC | All Rights Reserved
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
-
Proprietary & Confidential | Copyright © 2018 Excellis Health Solutions LLC | All Rights Reserved
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
-
Proprietary & Confidential | Copyright © 2018 Excellis Health Solutions LLC | All Rights Reserved
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
-
Proprietary & Confidential | Copyright © 2018 Excellis Health Solutions LLC | All Rights Reserved
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)
-
Proprietary & Confidential | Copyright © 2018 Excellis Health Solutions LLC | All Rights Reserved
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
-
Proprietary & Confidential | Copyright © 2018 Excellis Health Solutions LLC | All Rights Reserved
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
-
Proprietary & Confidential | Copyright © 2018 Excellis Health Solutions LLC | All Rights Reserved
Page 85
• Brief Background and Introduction
• Serialisation in Context
• Global Requirements
• Supply Chain Participants and Impacts
• Getting Started – a roadmap to success• Q & A
Agenda
-
Proprietary & Confidential | Copyright © 2018 Excellis Health Solutions LLC | All Rights Reserved
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
-
Proprietary & Confidential | Copyright © 2018 Excellis Health Solutions LLC | All Rights Reserved
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
-
Proprietary & Confidential | Copyright © 2018 Excellis Health Solutions LLC | All Rights Reserved
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….
-
Proprietary & Confidential | Copyright © 2018 Excellis Health Solutions LLC | All Rights Reserved
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
-
Proprietary & Confidential | Copyright © 2018 Excellis Health Solutions LLC | All Rights Reserved
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
-
Proprietary & Confidential | Copyright © 2018 Excellis Health Solutions LLC | All Rights Reserved
Page 91
You need the right team
-
Proprietary & Confidential | Copyright © 2018 Excellis Health Solutions LLC | All Rights Reserved
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?
-
Proprietary & Confidential | Copyright © 2018 Excellis Health Solutions LLC | All Rights Reserved
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?
-
Proprietary & Confidential | Copyright © 2018 Excellis Health Solutions LLC | All Rights Reserved
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?
-
Proprietary & Confidential | Copyright © 2018 Excellis Health Solutions LLC | All Rights Reserved
Page 97
What Goes Wrong?
Your ProgrammeThe Regulatory
Requirements
-
Proprietary & Confidential | Copyright © 2018 Excellis Health Solutions LLC | All Rights Reserved
Page 98
What Goes Wrong - Engaging your Senior Stakeholders
-
Proprietary & Confidential | Copyright © 2018 Excellis Health Solutions LLC | All Rights Reserved
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?"
-
Proprietary & Confidential | Copyright © 2018 Excellis Health Solutions LLC | All Rights Reserved
Page 100
Patient Journey = Program Journey
New opportunities
-
Proprietary & Confidential | Copyright © 2018 Excellis Health Solutions LLC | All Rights Reserved
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…
-
Proprietary & Confidential | Copyright © 2018 Excellis Health Solutions LLC | All Rights Reserved
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
-
Proprietary & Confidential | Copyright © 2018 Excellis Health Solutions LLC | All Rights Reserved
Page 103
• Brief Background and Introduction
• Serialisation in Context
• Global Requirements
• Supply Chain Participants and Impacts
• Getting Started – a roadmap to success
• Q & A
Agenda
-
Proprietary & Confidential | Copyright © 2018 Excellis Health Solutions LLC | All Rights Reserved
Page 104
Ian Haynes
-
Proprietary & Confidential | Copyright © 2018 Excellis Health Solutions LLC | All Rights Reserved
Page 105
1
0
5
-
Proprietary & Confidential | Copyright © 2018 Excellis Health Solutions LLC | All Rights Reserved
Page 106
• Background and Introduction
• Serialisation in Context
• Global Requirements
• Impact on Manufacturers
• Getting Started – a roadmap to success
• Want you want from your regulator – panel discussion
Agenda
-
Proprietary & Confidential | Copyright © 2018 Excellis Health Solutions LLC | All Rights Reserved
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
-
Proprietary & Confidential | Copyright © 2018 Excellis Health Solutions LLC | All Rights Reserved
Page 108
Illustrations © GS1
Serialisation: From Success to Challenge
2010 2017
-
Proprietary & Confidential | Copyright © 2018 Excellis Health Solutions LLC | All Rights Reserved
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
-
Proprietary & Confidential | Copyright © 2018 Excellis Health Solutions LLC | All Rights Reserved
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
-
Proprietary & Confidential | Copyright © 2018 Excellis Health Solutions LLC | All Rights Reserved
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
-
Proprietary & Confidential | Copyright © 2018 Excellis Health Solutions LLC | All Rights Reserved
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?
-
Proprietary & Confidential | Copyright © 2018 Excellis Health Solutions LLC | All Rights Reserved
Page 113
Counterfeit Medication – a closer look
Authentic Counterfeit
-
Proprietary & Confidential | Copyright © 2018 Excellis Health Solutions LLC | All Rights Reserved
Page 114
oftware?
Fake Credit Cards?
Narcotics?
ecisions, decision
s...
Counterfeit Pharmaceutical
s?
-
Proprietary & Confidential | Copyright © 2018 Excellis Health Solutions LLC | All Rights Reserved
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
-
Proprietary & Confidential | Copyright © 2018 Excellis Health Solutions LLC | All Rights Reserved
Page 116
• Impacting lifestyle drugs
• Branded medicines
• Generics
• High value
• Low value
• High volume
• Low volume
• Internet pharmacy a particular problem
A Global Problem
-
Proprietary & Confidential | Copyright © 2018 Excellis Health Solutions LLC | All Rights Reserved
Page 117
How do you turn all these requirements and uncertainties into something practical that we can deliver?
1
1
7
Impact on Manufacturing
-
Proprietary & Confidential | Copyright © 2018 Excellis Health Solutions LLC | All Rights Reserved
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
-
Proprietary & Confidential | Copyright © 2018 Excellis Health Solutions LLC | All Rights Reserved
Page 120
Program Organisation
Core Team
Sub team 1 Sub team 2 Sub team 3
Reference or stakeholder
group
Design Authority
Steering Group
-
Proprietary & Confidential | Copyright © 2018 Excellis Health Solutions LLC | All Rights Reserved
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
-
Proprietary & Confidential | Copyright © 2018 Excellis Health Solutions LLC | All Rights Reserved
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
-
Proprietary & Confidential | Copyright © 2018 Excellis Health Solutions LLC | All Rights Reserved
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
-
Proprietary & Confidential | Copyright © 2018 Excellis Health Solutions LLC | All Rights Reserved
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
-
Proprietary & Confidential | Copyright © 2018 Excellis Health Solutions LLC | All Rights Reserved
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
-
Proprietary & Confidential | Copyright © 2018 Excellis Health Solutions LLC | All Rights Reserved
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
-
Proprietary & Confidential | Copyright © 2018 Excellis Health Solutions LLC | All Rights Reserved
Page 127