AND UPDATES SERIALIZATION, TRENDS - Lars Olsen Lundbeck, Ottiliavej 9, 2500 Valby, Copenhagen, Denmark Thursday 21 September 2017
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SERIALIZATION, TRENDS
AND UPDATES
Lars Olsen
Lundbeck, Ottiliavej 9, 2500 Valby,
Copenhagen, Denmark
Thursday 21 September 2017
Biography Mr. Lars Olsen • Global Technology Partner, NNE • Dept. Global Best Practise, 2165 • +25 years experience within Pharmaceutical Packaging • Production, Management, Project handling, GMP and Consulting • e-mail: lao@nne.com • Phone: +45 30757362
Safety Features? Old news……
“Serialization”
Like driving a Car
Serialization is the number plate, but you need a lot more in order to drive
– A car to put the number plate on
– Insurance
– Driver instructor
– Drivers licence
– Roads & Signs
– A map to find your way
– Regulations & Laws
– Traffic Police
– Maintenance & Car dealers
I.e.: You’ll need more than a number plate to drive
Stakeholders
Economical fraud Fake- or substandard products
(Taxation/Reimbursement) (Counterfeit)
• Healthcare economy • General worries regarding population health due to
substandard medication
I.e. I.e.
• California (The exempted e-pedigree law) • EU/US/Canada/Brazil/Russia/Argentina/China……
• Turkey (Serialization 2009 / Aggregation 2011) • WHO
• Belgium (Sequential stickers) • And the rest of the world..
• Italy (Bolini stickers)
• Greece
• Other countries and states with similar problems where
suspicions of fraud are aimed at the pharmacist /
distribution and industry Problems to be solved in the same way as the EU four step
approach in the Falsified Medicine Directive. Focus on secure
Problem to be solved by coding on secondary- and tertiary supply chain (GDP/GSP), Internet sales, API/Excipients GMP and
packaging level with unique marking. Registration, aggregation, Delegated Act on Safety Features. Added with , “Fast reaction on
Pedigree and supply chain reporting/Track & Trace batch recall”. Currently many individual initiatives.
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Stakeholders
External Stakeholders Internal Stakeholders
(purchasing organizations) (Brand protection)
• Safe medication and usage, patients safety and • Protect your brands and creating precedence for new
inventory management industry standards and competitive parameter
I.e. I.e.
• HDA guideline (North American Distribution Association) • Pfizer, Amgen, Biogen, Sanofi, Lilly, AstraZeneca……and
• AMGROS (Purchasing org. hospitals in Denmark) many more.
• CII (Confederacy of India Industries)
• Veteran Hospital and Clinics (US) Securing trustworthiness of a brand so it’s easy to do “damage
• DOD (Department Of Defence, US) control” in case of forensic investigations on incidents. Typical
done by covert coding but also done with semi-covert and overt
• The Technical Barcode Committee (Canada)
options on all packaging levels. There are many different
• And similar General Purchasing Organisation technologies available on the marked (+40) some high cost, low
security others low cost, high security.
Registration of treatment and linking medication to individual
patients at hospitalization or clinics by intensively use of ISO 12931 ”Performance criteria for authentication solutions for anti-
Automated Identifier on primary- secondary and tertiary pack counterfeiting in the field of material goods” , However not yet referenced in
levels. Unique marking, RFID, QR and similar are in scope pharma- and device legislation.
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Summary
Global requirements will cover +80% of the pharmaceutical marked by 2019.
Global requirements are growing fast in complexity and scope
Standardisation of formats and data continues but diversity will continue to exist
Strategy, Operational and Technology flexibility are needed to fulfil requirements in a timely manner
Base Start Step 1 Step 4
Step 2 Step 3
Local Coding Global Coding Track & Trace /
GTIN + Batch variable Serial Number for
Reporting based on
(e.g. NHRN) (e.g. GTIN) data in 2D Data matrix authentication
Aggregation
Markets start with initial requirement that changes over time
Data reporting requirements are often not clear, hence ‘default’ becomes Unit Level Tracking
“Pharmaceutical Packaging Performance Excellence are a competitive cost differentiator which are being challenged
by Serialization”
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Summary Overview
+80% of marked by 2019
2017 2018 2019 2020 2021 2022 2023
Europe
Denmark
Coding 2)
European Union
France 09.FEB.2019
Italy
Belgium Serialization Can wait until
2025
Greece
Turkey 1)
1) Serialization, 2) Serialization, ATD and 3) Serialization and reporting by
Aggregation, reporting by law, Aggregation law, Aggregation by business.
reporting by law by business.
EFPIA Product- and Data-Flow End-to-End With the EFPIA concept
Pharma Manufacturer Wholesaler Wholesaler Pharmacist/ Hospital Patient
Product Flow
Unique Verification
Serialization
Verification Dispensing
2D Data
Matrix on 2°pack
Product
Data Transfer Serialization
Database
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Summary Overview
+80% of marked by 2019
2017 2018 2019 2020 2021 2022 2023
Asia
China1)
India 1) Domestically Serialization
distribution 1)
Pakistan Pakistan
Australia Australia Australia
Serialization.
NBA products only
Ramp up
Japan Japan Japan
Coding. Coding. Coding.
Special products All products All products
Philippines Malaysia
Coding Pilot
Voluntary
Taiwan Taiwan Taiwan
“Track and Trace” Coding Serialization
2)
South Korea
1) Serialization, 2) Serialization, ATD and 3) Serialization and reporting by
Aggregation, reporting by law, Aggregation law, Aggregation by business.
reporting by law by business.Summary Overview
+80% of marked by 2019
2017 2018 2019 2020 2021 2022 2023
North / South America
Serialization Grace
proposed by FDA
US US
Serialization 27.NOV.2018 Serialization, 27.NOV.2020
ATD by US Pharmacopeia Aggregation by
compliance business 1)
US US US US
Lot Tracking E-Lot Tracking 27.NOV.2017 Serialization, 27.NOV.2019
27.NOV.2023
Aggregation by
business
Canada Canada
Coding. Adaption of US FDA
Voluntary Serialization Guidelines expected
3) Scope update by positive list
Argentina
1)
Brazil Brazil Brazil Brazil
Pilot starts Pilot ends Pilot concluded Full rollout
Mexico
Serialization,
Consultation paper
1) Serialization, 2) Serialization, ATD and 3) Serialization and reporting by
Aggregation, reporting by law, Aggregation law, Aggregation by business.
reporting by law by business.Summary Overview
+80% of marked by 2019
2017 2018 2019 2020 2021 2022 2023
Middle East
Expected development in 2 – 3 years 2)
Saudi Arabia Saudi Arabia
12.MAR.2017
Serialization
Oman Oman
31.DEC.2017 31.DEC.2018 2)
Coding Serialization GCC
+2020
UAE UAE
31.DEC.2017 Expected to develop into a new GCC
Coding Expected development Serialization standard, adapted by other Arab
in 2 – 3 years markets
Qatar Qatar
31.DEC.2017
Coding Serialization
Migration period
Jordan Jordan Jordan
01.JUN.2017 30.JUN.2018 Start 2020
Coding Coding Serialization
Libya Lebanon
01.JUN.2018
Coding 01.JUN.2017 Coding
1)
Egypt Egypt Egypt
Coding Serialization 30.JUN.2018 30.JUN.2019
1) Serialization, 2) Serialization, ATD and 3) Serialization and reporting by
Aggregation, reporting by law, Aggregation law, Aggregation by business.
reporting by law by business.Summary Overview
+80% of marked by 2019
2017 2018 2019 2020 2021 2022 2023
RoW
MoH may align with EU
Ukraine European Union
On hold
Serialization
1)
Russia Russia Russia Russia
01.JAN.2017 01.JAN.2018 01.JAN.2019 01.JAN.2020
Voluntary pilot Product group 1 Product group 2 Product group 3
initiated
1) Serialization, 2) Serialization, ATD and 3) Serialization and reporting by
Aggregation, reporting by law, Aggregation law, Aggregation by business.
reporting by law by business.Anti-tampering Device (ATD)
General Requirements
Purpose of ATD features:
“Tamper verification features should provide an indication that the outer
packaging of a finished product has been opened or tampered with (i.e. indicating
a possible adulteration or entry of falsified medicinal products into the legitimate
supply chain). Tamper verification features limit the ability to replace the contents
of genuine packs.”
Source: EN 16679:2014 (soon an ISO standard)Categories of ATD features Folding boxes closed with glue Specially constructed folding boxes Sealing labels and tapes Film wrappers Sleeves Breakable or tear-away closure Display blister pack Flexible packaging Blow-fill-and-seal-container (BFS) New and emerging technologies Don’t forget Shipper Boxes and Pallets….. USP c1083 and so on…
Things to consider • What needs to be Reported and what has to be Authenticated, and how, where, when? • How will Commissioning, Decommissioning and Recommissioning be done and by whom? • Know your SKU’s and exact market demands in details • Know your Supply Caine stakeholders and your Partners business and needs • Make a business strategy which goes beyond the “Number plate”, get it mandated and stick to it, but be prepared to change over time • Scope for robustness and justify the upfront CAPEX invest
The challenge Number of SKU’s increasing OEE decreasing Flexibility decrees High CAPX Increased OPEX Operator / Technician / Support knowledge Extra work routines on all levels Supplier dependences System maintenance Hyper care Rooting ownership in organisation
The challenge
The challenge
Assembly 96.5%
Check weigher
Piston rod 99.5%
99.5%
Assembly
98%
Cartoner 98% Label dispenser & Cellophane
Printer 97.5% wrap 99% Case packing
Buffer 99.5% (manual)
98.5%
Radom 99%
Labeling
99.5%
Syringe 98.5% Stopper
99%
Example:
• 35 meter long syringe packaging line with 13 sub-processes
• Combined efficiency calculated according to DIN 8743 ~ 83%
• In reality much lower…..
• Add extra complexity from Serialization, Anti-tampering Device, Aggregation, Track &
Trace, ePedigree, China EDMC and many others we’ll have a further potential OEE
drop of 8 – 12%Industry Benchmark Data
Baseline, Relative Production Output (%) X%
T0
1-5% Δ from T0
Return to stable output
~ 10% Recovery Phase
~ 25%
Start up; Output Reduced Relative to T0
Low Impact
Medium Impact
High Impact
High Impact
Medium Impact
Low Impact
0%
0 2 4 6 4 6 8 10 12 14 16 18 20 22 24 26 28 30 32 34 36 38 40 42 44 46 48 50 52
Line down/Set up Relative Duration (Weeks)Technology trends
White Line
The world first true White Line was introduced by Optima/Eli Lilly in 1994/96 to fulfil Small batch size (15 min. video exist)
MediSeal introduced the second line 20 years later
White Line concept have been successfully utilized by ALK since mid-90’s on order sizes up to 2.000 units with proven cost
benefit. Also in combination with Bright Stock configurable sales boxes by TT-label and Robot labelling to accommodate many
formats
Connecting Pharmaceutical Knowledge ispe.orgTechnology trends
Multi Country packs
Multi Country packs are a familiar concept in the Pharmaceutical packaging world in order to optimize batch volume
Multi-packs are stored in central warehouses and Pick & Pack performed when order enters
Modern Serialization will challenge this concept to some degree
Example here covers 17 individual markets in one presentation
Connecting Pharmaceutical Knowledge ispe.orgTechnology trends
Other on-demand trends
BIB/BOB. Original developed by AZ and Harro. Now offered as standard solution for
POD. For repack of Bright Stock
Print on demand for local small batch execution. Many variances
Robot labelling if many formats in small batch sizes
Robot packaging and Co-bots for product handling for HSE mitigations and repeatable reliable execution and quality
Connecting Pharmaceutical Knowledge ispe.orgTrends There are no doubt that Pharmaceutical Packaging are challenged by demands to be more cost effective This is based on markets trends headed by increased competitiveness, smaller batch sizes, costumer centricity, diversity in local legislations (S/N), increase demands for reimbursement favouritism (local production), supply chain lead-times, drug shortage (stock-out mitigations), new drugs and many more Packaging Delivers: 2015 Pharma Packaging Trends 4 Major Trends In Pharmaceutical Packaging 2017 Pharmaceutical Packaging and Labeling 2016 Trend Report #1: Use standard platforms and equipment for all three segments in the same way that large Pharma are using it towards tablet production #2: Design for simplicity and standard equipment (DFM) #3: Do not utilize White line and Print on Demand unless super-small batches (
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