Kvalitetsdagen / Quality-day Oslo, 22.september 2014 World Class Pharmaceutical Packaging & Serialization with special focus on unique identifiers Lars Olsen, Senior Technology Partner, Global Consulting, Serialization, NNE Pharmaplan (Denmark) Biography • • • • • • 2 Mr. Lars Olsen Dept. Global Consulting, 2265 Serialization Senior Technology Partner +25 years experience with Pharmaceutical Packaging Production, Management, Project handling and Consulting e-mail: [email protected] Biography 3 4 The OSD perspective 5 Introduction • “License to Operate” • GDP/GSP compliance • RA compliance to Anti-counterfeit laws • Tender requirements from GPO’s • Brand protection • In short: • Unit Cost and Profitability are under threat • Invest is high RA compliance to Anticounterfeit laws GDP/GSP compliance Tender requirements from GPO’s “Serialization” is not just solved by adding another Band-Aid. It’s a longterm commitment and investment so why not reach out for World Class Pharmaceutical Packaging? 6 Brand protection Profitability & Cost Terms and concept Serialization ~ Codification Human ID • • • • • • • • • • • Name Gender/race Date of birth Place of birth Physical appearance and description Social security number Fingerprint Iris scanning DNA Passport, drivers license, ID cards (combo ID doc.) “Nem ID” Drug ID • • • • • • • • • • • GTIN/NDC/PZN/CIP Lot # Mfg./Exp. date GLN Color, Shape, Strength, Numbers Hardness SSCC SN UV reflection API excipients profile Covert Coding / Pragmatic Features (ISO 12931) • Tamper Verification for integrity (EN16679) • Carriers: Barcodes, RFID, Human readable data 7 Stakeholders Economical fraud Fake- or substandard products (Taxation / Reimbursement) • Healthcare economy I.e. • California • Turkey • Belgium • Italy • Other countries and states with similar problems where suspicions of fraud are aimed at the pharmacist / distribution and industry (Counterfeit) • General worries of population health due to wrong medication that originates from use of faked products (device and drugs) I.e. • EU/US/Canada/Brazil/Russia/Argentina/Ch ina…… • And many, many more….. Problem to be solved by intensively coding on secondary- and tertiary packaging level with unique marking. Registration, aggregation, Pedigree and Track & Trace with 100% control of supply / distribution chain. 8 Problems to be solved more or less in the same way as the EU three step approach with unique marking on secondary pack level (sales level) for end of distribution authentication. Focus on secure supply chain (GDP/GSP), Internet sales, fast reaction planning, Batch recall. Currently many individual initiatives also within EU that diverts from each other Stakeholders 9 External Stakeholders Internal Stakeholders (purchasing organizations) • Safe medication and usage, patients safety and inventory/logistic management I.e. • HDMA guideline (North American distribution) • AMGROS (DK) • MoHFW (India) • Veteran Hospital and Clinics (US) • DOD (US) • The Barcode Committee (Canada) • And similar GPO’s 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 (Brand protection) • When trying to protect your brands new methodologies are developed and can create precedence for new industry standards which potential can develop into a competitive parameter I.e. • Pfizer, Amgen, Biogen Idec, Sanofi Aventis, Lilly, AstraZeneca……and many more. Securing trustworthiness of a brand so it’s difficult to harm and “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 007 technologies available on the marked (+40 at least) ranging from high cost, low security to low cost, high security. ISO 12931 ”Performance criteria for authentication solutions for anti-counterfeiting in the field of material goods” ,2012. However not yet referenced in pharma- and device legislation. Summary Global requirements will cover +80% of the pharmaceutical marked by 2018. Driven by laws and supply chain stakeholders Global requirements are growing fast in complexity and scope • Little or no standardization and harmonisation • New countries will adapt on a fast track • Growing complexity will be a technological challenge Stakeholders and Authorities are moving towards standardisation of formats and data but diversity will continue to exist Complexity prompts the need for Strategy, Operational and Technology flexibility to fulfil requirements in a timely manner Base State – Local Coding (e.g. NTIN) Global Coding GTIN GTIN + Variable data in 2D Data matrix Addition of Serial Number into 2D Data matrix Unit Level Tracking / Data Reporting based on Aggregation Experience has shown that markets start with initial requirement that changes over time Data reporting requirements are often not clear in legislation (e.g. Argentina, South Korea), hence ‘default’ becomes Unit Level Tracking approach which requires aggregation 10 Summary Overview +40 countries and +80 of marked by 2018 2013 & prior 2014 2015 2016 2017 2018 Europa / EMEA Denmark Slovenia Coding France Italy Can develop up until 2023 Italy Serialization (stickers) Serbia Greece Turkey Serialization, reporting Bollini law. Decree updates expected Belgium European Union Coding Serialization, reporting (stickers 2D Datamatrix) Serialization (stickers) Unit level tracking, reporting Asia China Unit level tracking, reporting EDL 2009 PEDL Updates China EDL 2012 China Complex export law. Import only Coding India All India Australia Serialization Unit level tracking, reporting (expected) Coding Philippines Coding Japan Coding Singapore Taiwan South Korea Coding South Korea Serialization 11 South Korea Serialization, reporting South Korea Unit level tracking, reporting (expected) Serialization, reporting (expected to adapt US FDA Guidelines) Summary Overview +40 countries and +80 of marked by 2018 2013 & prior 2014 2015 2016 2017 2018 North / South America USA HDMA Step wise Supply Chain Mobilization USA USA Serialization, reporting Lot tracking & verification Coding Step wise implementation Canada Unit level tracking, Dept. of Defense reporting + RFID (not enforced) Argentina Unit level tracking, reporting Updates on positive list Canada Pilot. 3 lots Full rollout Brazil Argentina Unit level tracking, reporting Phase 2 Canada Serialization, reporting (expected to adapt US FDA Guidelines) Coding Brazil Mexico Unit level tracking, reporting Serialization, reporting Chile Coding Lot Tracking Proposal Serialization, expected Colombia Algeria 2 steps. Serialization & Unit level tracking Middle East Saudi Arabia Saudi Arabia Serialization Coding Jordan Egypt Serialization Coding Libya RoW Serialization Nigeria Ukraine Serialization MAS Serialization South Africa Unknown requirements and deadlines 12 Cameroon Serialization expected no deadline Russia Serialization, expected Summary Overview Country Status Scope Dates Coding Serialization Tracking Authentication Reporting Algeria Draft All 2017 X X Argentina Law All (steps) 2012 - 2014 X X X Belgium Law All 2004 X X X Brazil Law All 2015 – 2016 X X X Cameroon Proposal All TBD X X X Canada Law All 2012 – 2017 X Chile Proposal All TBD X China Law All (steps) 2009 - 2016 X X X Columbia Law/Draft All TBD X X X EU Law All (exemptions) 2018 X X India Law All 2011 - 2014 X X Italy Law All 2005 2016 X X X Japan Law All 2015 X Jordan Law All 2017 X X X Libya Proposal All TBD X X X Mexico Law/Proposal All TBD X X Nigeria Law All (steps) 2014 X X Philippines Law All 2015 X Russia Proposal All TBD X X Saudi Arabia Law All 2015 – 2017 X X Singapore Proposal Injectables 2015 X Slovenia Law All 2015 – 2018 X South Africa Proposal All TBD 13 X X X X X X X X Summary Overview Country Status Scope Dates Coding Serialization Tracking Authentication Reporting South Korea Law All 2009 – 2016 X X Taiwan Proposal All (steps) TBD X X Turkey Law All 2009 - 2012 X X X Ukraine Draft All 2017 X X X United States Law All (exemptions) 2015 - 2023 X X 14 X X X X Key Tracking Requirements Generating, Acquiring and managing of Serial Numbers Exchange of Tracking information Authentication of Serial Numbers and Transactions Government Agencies & Supply Chain Partners Reporting on Products and Transaction Government Agencies & Industry owned databases • When is Tracking information required to be exchanged? • Products Manufacturing • Products imported/Exported • Products sales, distribution, receipt, returned, destruction and many more • What kind of Tracking information is required to be exchanged? • Product codes (GTIN, NTIN, NHRN), Event date, Lot number, Expiry date, Serial numbers • Sellers, buyers, distributers, transaction ID (Transaction information, history, statements). Typical PO, delivery and invoicing documents • Who is required to supply and exchange Tracking information • Manufacturers, CMO – CPO’s, re-packs, re-dressers, Kitters, 3PL’s, Wholesalers, Distributers, Pharmacies and Return processes 15 Key Tracking Requirements Serialization Tracking Authentication Reporting Generating, Acquiring and managing of Serial Numbers Exchange of Tracking information Authentication of Serial Numbers and Transactions Reporting on Products and Transaction Algeria Libya Brazil European Union Argentina Nigeria Argentina Mexico Cameroon Nigeria Brazil Saudi Arabia Brazil Nigeria Chile USA China South Africa Cameroon Saudi Arabia India (Expected) Colombia South Korea Chile South Africa USA European Union Taiwan China South Korea India (Expected) Turkey Colombia Taiwan Jordan Ukraine European Union Turkey Libya USA India Ukraine Mexico Jordan USA 16 Examples 17 Packaging today Check weigher 99.5% Assembly 98% Piston rod 99.5% Assembly 96.5% Primary pack: Moderate Line impact Secondary pack: Significantly End of Line impact Buffer 99.5% Stopper 99% Labeling 99.5% Syringe 98.5% Cellophane wrap 99% Radom 99% Cartoner 98% Label dispenser & Printer 97.5% Case packing (manual) 98.5% Example: • • • • • 18 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, Tamper evident, Aggregation, Track & Trace, ePedigree, China ESC and many others we’ll have a further potential OEE drop of 8 – 12% Add modern Patient Centric Strategy and OEE drop is nearly unlimited but that’s another story Packaging today EOL Strategy in connection to Serialization, Tamper Evident, Aggregation and Track & Trace The average typical European packaging line: Age: Mid to late ’90 Mid speed 300/150 tablet blister • Semi-manual EOL • Upgraded over the years by “Salami tactic” (BandAid’s) • Typical manned by 3 – 4 high cost operators • OEE max. 40 – 60% (some even lower) • Space constringes “Security Module” “Case packing” “Palletizing” Automated if 20 – • Contribute with typical Print, verify, upload, Stickers Aggregation, Print & Apply. volume is high and business 25% of product operational and Tamper evident. In some Generating shipping case shows cost! a good ROI. Significantly COGS impact cases also implementing Check information needed for Used• for Aggregation, Print Weighing. Space saving 19 T&T and Pedigree • • & Apply to pallet Packaging of tomorrow • • • • • • Cross organizational corporation Map dependences Define roles and responsibilities Define sub projects, strategy and scope Milestones and full coordination between groups Report to governance group QA Sales and Marketing Legal / CCC Pack dev. IT Codification Project Logistic RA Production CMO/CPO Packaging of tomorrow • • • • • • Governance group support and sponsoring Define key members Define sub organization Root projects responsibilities in job description and ensure management support and involvement (mobilization) Need for external project support clarified Local involvement and follow-up Governance group Project PM Support IT Sales Marketing Pack material dev. Logistic Production Sites CMO’s RA Packaging of tomorrow • Special customized linear code on salesand shipping level • • • Authentication on sales- and shipping level Batch level tracking Later: Unit Level Tracking 50.000.000 45.000.000 40.000.000 35.000.000 30.000.000 25.000.000 • Serialization on sales level 20.000.000 15.000.000 10.000.000 5.000.000 0 • • • • • • • • • Falsified medicine directive Good Distribution Practice Serialization on sales unit level End to end authentication Tamper Verification Batch Recall focus Fast Reaction Safe Medication • • • • Reimbursement and taxation fraud Serialization on sales level and up Aggregation for possible tracking Country EU Tyrkiet China US Brazil Argentina Korea South India Sales packs 46.497.810 3.639.200 2.072.600 908.877 840.046 472.000 182.650 0 Commodity numbers Special MoHFW codification requirements Special KD codification requirements 804 23 7 12 14 12 5 5 23 Examples 24 World Class Pharmaceutical Packaging Equipment configuration • 10 packaging lines in one pack hall • Four identical mid speed blister lines • One dedicated to high containment • One dedicated to Alu • Two PVC/Alu • Four identical bottle lines • Two mid speed for fast changeover small batch runs • Two high speed for large batch runs • Two semi-automatic lines • For small orders and flexible execution • Small Highlights: Serialization by Security module. EOL prepared for aggregation/RFID. Tablet feeding by Sypro/Simtap/Sombrero on all blister lines. RABS/Isolator tech on containment. MES Water injection for fast changeover. Possibility to feed bottle/blisters directly or with buffer Large leaflets by “Multilayer” (no changeover) Clear production strategy 25 World Class Pharmaceutical Packaging Environment configuration • Possibility to go 24/7, Normally 14 shifts per week • Manning per shift: • One Team Leader • One MH • One QA rep. • One Technician • 1½ FTE per blister line • 2 FTE per bottle line • Very clear Rolls & Responsibilities • Average efficiency (OEE1): +97% • Average batch freeing: 20 min. • Optimized format standardization • Deviations pre batch insignificantly low • “Right first time” always • On-line QA on all shifts 26 World Class Pharmaceutical Packaging Unit level tracking Low cost invest: • Longer downtime for rebuild and system integration (+4 weeks). OEE losses 8 – 12% and two extra FTE Mid cost invest: • Typical downtime pr. Line 3 – 4 weeks. OEE losses 5 – 7% and one FTE High cost invest: • Typical downtime pr. Line 1 – 2 weeks. OEE losses 1 – 3% and approx. ½FTE New EOL “State of the art”: • One week downtime. Off-line qualification. Potential OEE gain 1 – 3% and potential one FTE reduction A few learning’s: 1. Balanced cost approach highly needed (Business Case) 2. Standardization of packaging concepts are precondition for success 3. Change Management 4. Early stakeholder involvement 27 World Class Pharmaceutical Packaging Using your Serialization project as leverage to gain higher output • Logistical- and marked alignment • Production strategy • Implement statistical batch release based on IPC and SN • Go for full MES • Automate your End Of Line • Standardize your formats • Prospective or retrospective Design For Manufacturing • Incorporate new innovative technical solutions • Change Management, Q-setup 28 World Class Pharmaceutical Packaging “Meet the Doctor” Voice information Interactive user guide Videos Adverse reaction warnings “Marketing” of improved and new products to match client profile • Q&A sessions • • • • • eLeaflets® are on the move in Australia and EU is working on a program for implementation Continues management of data Looping back Data exchange / fact based information *Example poster are for Medical Devices Healthcare focus: Compliance Standardization Safe Medication Improved therapy eRecords Full transparency Inventory management Manufacturing and R&D: Patient enhanced and patient driven development and production philosophy Automated Identifiers / data elements on all packaging levels Data exchange / fact based information Continues data looping throughout the full Life Cycle Conclusion Summarizing: By enhancing attention and lifting your Codification projects to a new level you will be able to achieve “World Class Performance” • • • • • • • • • • OEE +97% COGS improvements (manning savings and improved output) Competitiveness in the world of tomorrow Right first Time Increase quality Gain robustness and internal logistical trustworthiness Minimizing storage Support Just In Time Supreme compliance Possibility to do data based LCM It only takes the right mind-set and a focused investment plan. But the catch is that you’ll have to justify the extra invest 32 “Hello World” May 2006 I love deadlines. I like the whooshing sound they make as they fly by. Douglas Adams (Hitchhikers Guide to the Galaxy) 33 Questions? 34
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