SERIALIZATION, TRENDS AND UPDATES. Lars Olsen Lundbeck, Ottiliavej 9, 2500 Valby, Copenhagen, Denmark Thursday 21 September 2017

Transcription

1 SERIALIZATION, TRENDS AND UPDATES Lars Olsen Lundbeck, Ottiliavej 9, 2500 Valby, Copenhagen, Denmark Thursday 21 September 2017

2 Biography Mr. Lars Olsen Global Technology Partner, NNE Dept. Global Best Practise, years experience within Pharmaceutical Packaging Production, Management, Project handling, GMP and Consulting Phone:

3 Safety Features? Old news

4 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

5 Stakeholders Healthcare economy I.e. Economical fraud (Taxation/Reimbursement) California (The exempted e-pedigree law) Turkey (Serialization 2009 / Aggregation 2011) Belgium (Sequential stickers) Italy (Bolini stickers) Greece Other countries and states with similar problems where suspicions of fraud are aimed at the pharmacist / distribution and industry Problem to be solved by coding on secondary- and tertiary packaging level with unique marking. Registration, aggregation, Pedigree and supply chain reporting/track & Trace Fake- or substandard products (Counterfeit) General worries regarding population health due to substandard medication I.e. EU/US/Canada/Brazil/Russia/Argentina/China WHO And the rest of the world.. Problems to be solved in the same way as the EU four step approach in the Falsified Medicine Directive. Focus on secure supply chain (GDP/GSP), Internet sales, API/Excipients GMP and Delegated Act on Safety Features. Added with, Fast reaction on batch recall. Currently many individual initiatives. Connecting Pharmaceutical Knowledge ispe.org

6 Stakeholders External Stakeholders (purchasing organizations) Safe medication and usage, patients safety and inventory management I.e. HDA guideline (North American Distribution Association) AMGROS (Purchasing org. hospitals in Denmark) CII (Confederacy of India Industries) Veteran Hospital and Clinics (US) DOD (Department Of Defence, US) The Technical Barcode Committee (Canada) And similar General Purchasing Organisation Registration of treatment and linking medication to individual patients at hospitalization or clinics by intensively use of Automated Identifier on primary- secondary and tertiary pack levels. Unique marking, RFID, QR and similar are in scope Internal Stakeholders (Brand protection) Protect your brands and creating precedence for new industry standards and competitive parameter I.e. Pfizer, Amgen, Biogen, Sanofi, Lilly, AstraZeneca and many more. Securing trustworthiness of a brand so it s easy to do damage control in case of forensic investigations on incidents. Typical done by covert coding but also done with semi-covert and overt options on all packaging levels. There are many different technologies available on the marked (+40) some high cost, low security others low cost, high security. ISO Performance criteria for authentication solutions for anticounterfeiting in the field of material goods, However not yet referenced in pharma- and device legislation. Connecting Pharmaceutical Knowledge ispe.org

7 Summary Global requirements will cover +80% of the pharmaceutical marked by 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 Local Coding (e.g. NHRN) Step 1 Global Coding (e.g. GTIN) Step 2 GTIN + Batch variable data in 2D Data matrix Step 3 Serial Number for authentication Step 4 Track & Trace / Reporting based on 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 Connecting Pharmaceutical Knowledge ispe.org

8 Summary Overview +80% of marked by 2019 Europe Denmark France Coding 2) European Union 09.FEB.2019 Italy Belgium Greece Turkey 1) Serialization Can wait until 2025 ) Serialization, 2) Serialization, ATD and 3) Aggregation, reporting by law reporting by law, Aggregation by business. Serialization and reporting by law, Aggregation by business.

9 EFPIA Product- and Data-Flow End-to-End With the EFPIA concept Pharma Manufacturer Wholesaler Wholesaler Pharmacist/ Hospital Patient Product Flow Unique Serialization Verification Verification Dispensing 2D Data Matrix on 2 pack 9 Data Transfer Product Serialization Database

10 Summary Overview +80% of marked by Asia China 1) 1) India Domestically distribution Serialization Pakistan 1) Pakistan Australia Serialization. NBA products only Japan Coding. Special products Australia Japan Coding. All products Ramp up Japan Coding. All products Australia Philippines Coding Voluntary Taiwan Track and Trace South Korea 2) Malaysia Pilot Taiwan Coding Taiwan Serialization ) Serialization, 2) Serialization, ATD and 3) Aggregation, reporting by law reporting by law, Aggregation by business. Serialization and reporting by law, Aggregation by business.

11 Summary Overview +80% of marked by 2019 North / South America US Lot Tracking Serialization Grace proposed by FDA ATD by US Pharmacopeia compliance E-Lot Tracking US 27.NOV.2017 Canada Coding. Voluntary Serialization 3) Scope update by positive list Argentina US Serialization 27.NOV.2018 Serialization, Aggregation by business US 27.NOV.2019 Serialization, Aggregation by business US 27.NOV.2020 Canada Adaption of US FDA Guidelines expected 1) US 27.NOV.2023 Brazil Pilot starts Brazil Pilot ends Brazil Pilot concluded 1) Brazil Full rollout Mexico Serialization, Consultation paper 1) Serialization, 2) Serialization, ATD and 3) Aggregation, reporting by law reporting by law, Aggregation by business. Serialization and reporting by law, Aggregation by business.

12 Summary Overview +80% of marked by Middle East Saudi Arabia Serialization 12.MAR.2017 Expected development in 2 3 years 2) Saudi Arabia Coding Coding Coding Oman 31.DEC.2017 UAE 31.DEC.2017 Qatar 31.DEC.2017 Oman Serialization 31.DEC.2018 Expected development in 2 3 years Serialization Serialization UAE Qatar 2) GCC Expected to develop into a new GCC standard, adapted by other Arab markets Coding Jordan 01.JUN.2017 Migration period Coding Jordan 30.JUN.2018 Jordan Start 2020 Serialization Coding Coding Egypt Libya 01.JUN.2017 Coding Serialization Lebanon 01.JUN.2018 Egypt 30.JUN.2018 Egypt 1) 30.JUN ) Serialization, 2) Serialization, ATD and 3) Aggregation, reporting by law reporting by law, Aggregation by business. Serialization and reporting by law, Aggregation by business.

13 Summary Overview +80% of marked by 2019 RoW Ukraine On hold Serialization MoH may align with EU European Union Russia 1) 01.JAN.2017 Voluntary pilot initiated Russia 01.JAN.2018 Product group 1 Russia 01.JAN.2019 Product group 2 Russia 01.JAN.2020 Product group 3 1) Serialization, 2) Serialization, ATD and 3) Aggregation, reporting by law reporting by law, Aggregation by business. Serialization and reporting by law, Aggregation by business.

14 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)

15 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 Categories of ATD features Don t forget Shipper Boxes and Pallets.. USP c1083 and so on

16 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

17 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

18 The challenge

19 The challenge Piston rod 99.5% Assembly 96.5% Check weigher 99.5% Assembly 98% Buffer 99.5% Cartoner 98% Label dispenser & Printer 97.5% Cellophane wrap 99% Case packing (manual) 98.5% Labeling 99.5% Radom 99% 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%

20 Baseline, Relative Production Output (%) Industry Benchmark Data X% T 0 1-5% Δ from T 0 ~ 10% ~ 25% Recovery Phase Return to stable output Start up; Output Reduced Relative to T 0 Low Impact Medium Impact High Impact High Impact Medium Impact Low Impact 0% Line down/set up Relative Duration (Weeks)

21 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 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.org

22 Technology 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.org

23 Technology 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.org

24 Trends 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 (<2.000) and a good business case #4: Combine Flex-Small approach with LSC and Multi Country but watch out for S/N impact #5: Consider your CMO/CPO partners in the scope for in- or outsourcing

25 25

26 Hello World May 2006 I love deadlines. I like the whooshing sound they make as they fly by. 26 Douglas Adams (Hitchhikers Guide to the Galaxy)