Preparing Your IT Infrastructure, Internal Operations and Supply Network for Track and Trace Regulations

Transcription

1 Preparing Your IT Infrastructure, Internal Operations and Supply Network for Track and Trace Regulations ISPE Professional Development Day New Brunswick, NJ

2 Agenda and Speaker Agenda Global Track and Trace Requirements, Challenges and Strategies Master Data Impacts of Serialization and Track and Trace Business Process Touch Points and Layering Serialization Over Operations Speaker Brian Daleiden Vice President Marketing TraceLink Network Integration and Data Exchange Considerations Pulling It All Together: China Case Study Global Track and Trace Solution Capabilities and Preparation Checklist Q & A TraceLink Inc. All Rights Reserved. ISPE Serialization Program March 20, 2014

3 Global Track and Trace Requirements, Challenges and Strategy Development ISPE Professional Development Day New Brunswick, NJ

4 Key Global Track and Trace Requirement Themes Generate, Acquire and Manage Serial Numbers Exchange Track and Trace Information Verify Serial Numbers and Transactions Report on Products and Transactions SC Partners Gov t Agencies SC Partners Gov t Agencies SC Partners Gov t Agencies Gov t Agencies When is track and trace information required to be exchanged? - Product Manufactured / Serialized - Product Imported, Exported - Product Sales / Distributions, Product Receipt, Product Returned, Product Destruction, etc. - Product Movements What kind of track and trace information is required to be exchanged? - Event date, serial numbers, product code (e.g., GTIN, country registration code), lot number, expiration date - Seller, buyer, transaction ids (e.g., PO, delivery document, invoice) Who is required to supply and/or exchange track and trace information? - Pharma companies, CMO/CPOs, Repackagers, Kitters, 3PLs - Returns Processors, Wholesale Distributors, Pharmacies/Clinics TraceLink Inc. All Rights Reserved. ISPE Serialization Program March 20, 2014

5 Building the Global Track and Trace Analysis Chart (selective 5 country example) Requirement US China Argentina Brazil Turkey Serialization Serial Number Creator Manufacturer Government Manufacturer Manufacturer Manufacturer Serial Number Format GS1 Standard (SNI in SGTIN format) TraceLink Inc. All Rights Reserved. ISPE Serialization Program March 20, digit custom GS1 Standard 13 digit custom GS1 Standard Randomization Aggregation Products Product Scope (not incl. certain product type exceptions) Rx, All Rx, Phased Rx, Phased Rx, Phased Rx, All Supply Chain Transaction Tracking / Government Event Reporting Product Manufactured Serial Number Replaced Product Imported Product Sales / Distribution Product Transfer Product Donation / Samples Product Exported Product Receipt from Purchase Product Return Distribution Product Return Receipt Product Restocked Product Quarantined Product Withdrawn / Recalled Product Expired Product Damaged / Product Destroyed / Serial Number Deactivation Product Stolen / Lost Product Sampled (quality) Product Verification Query

6 Global Track & Trace Challenges Global Track & Trace compliance requires organizations to think differently about their supply chain networks, business processes and IT architectures Global Supply Network Integration Challenge: Integration of 100s of supply chain partners for track & trace messaging and compliance Strategy: Network Approach Big Data Challenge: Terabytes of data and 100,000s of transactions cannot be managed through traditional enterprise architectures Strategy: Native Cloud Architecture Changing Standards and Regulations Challenge: Regulations and standards are continuously evolving and will continue to evolve for the foreseeable future. Strategy: Multi-tenant and Validated Strategic Value Challenge: Drive strategic business value from track & trace compliance investments Strategy: Extensible Solution Platform TraceLink Inc. All Rights Reserved. ISPE Serialization Program March 20, 2014

7 Global Track & Trace Challenges Global Track & Trace compliance requires organizations to think differently about their supply chain networks, business processes and IT architectures Global Supply Network Integration Integration of 10s to 1000s of supply chain partners for track & trace messaging and compliance Big Data Terabytes of data and 10,000s to 1,000,000s of transactions cannot be managed through traditional enterprise architectures Changing Standards and Regulations Regulations and standards are continuously evolving and will continue to evolve for the foreseeable future Strategic Value Track and trace compliance is a huge investment, yet sets the stage for developing strategic business value through better information and supply chain visibility TraceLink Inc. All Rights Reserved. ISPE Serialization Program March 20, 2014

8 Aligning Global Requirements to Business Strategy and Operational Procedures Business Strategy Survey Strategic Elements Ensure regulatory compliance for existing, new markets Operational extensibility for future regulations IT architecture extensibility for future regulations Deployment repeatability and scalability New product launch integration Operational Goals Flexibility (meeting diverse requirements) Agility (meeting unanticipated regulations) Global standardization vs. local deployment Responsiveness (data updates, user/system access) Cost effectiveness Operational Planning Analysis - Analyze overall network for required operational event capture Manufacturing and packaging lines (internal, CMO/CPOs) Finished goods warehouses in manufacturing network Distribution network (3PLs, distribution partners, importers/agents, dispensation points) Government agencies - Identify business process requirements to meet and maintain compliance Standard business processes (sales/shipment, purchase/receiving, returns, special processes like drop shipment) Exception handling - Define Operations Requirement Flows Operationally agnostic to mandates Minimize operations impacts and change management burden Automated and/or manual compliance activities TraceLink Inc. All Rights Reserved. ISPE Serialization Program March 20, 2014

9 Impacts of Serialization and Track and Trace on Master Data ISPE Professional Development Day New Brunswick, NJ

10 Considerations for Developing a Track and Trace Master Data Management Strategy Existing Master Data What Master Data do I already have? - Product MD: GTIN, Country Drug Code (US - NDC, Germany - PZN) - Customer MD: Business name and address What systems does the current Master Data reside in? - ERP, SCM/warehouse management, CMO/CPO systems, local country partner systems What is your strategy for making the Master Data available to the track and trace systems New Master Data What new Master Data is required for global track and trace? - Product MD: China 3 levels of product identifier (product code, subtype code, resource code), new product attributes such as Code Version, Code Level and Packaging Ratio - Customer MD: Country-specific company identifiers (e.g. Brazil CNPJ, Argentina CUIT, GLN) - Partner/Channel MD: Brazil - Company identifiers, business name and address for carriers As the company serializes to meet new country mandates, how do I identify and collect new Master Data? In what systems will this new track and trace Master Data be maintained? What are the supporting track and trace systems that will be the consumers of the Master Data and which classes of Master Data is required for each? - Packaging line systems - Serialization management systems - Regulatory compliance and reporting systems TraceLink Inc. All Rights Reserved. ISPE Serialization Program March 20, 2014

11 Business Process Touch Points and Laying Serialization over Operations ISPE Professional Development Day New Brunswick, NJ

12 Determine Strategy for Layering Serialization and Event Tracking Over Logistics Processes Fully Integrated Approach Over the Top Approach Serialization Repository Serialization Repository A B C A B C Internal Distribution Network Scan / update on every internal product movement or change in form Internal Distribution Network Scan / update on receipt into network, shipment to customers and aggregation changes Determine depth of operational integration - Regulatory-driven, Operationally-driven, both Determine which business processes and operational systems need to be serialized inventory aware - WMS, Inventory Management, Shipping / Receiving, etc. Determine which regulations and processes impact the state of data in the serialization repository - E.g. Aggregation, Brazil movement tracking, etc. Minimize change management and errors by postponing updates and eliminating touch points TraceLink Inc. All Rights Reserved. ISPE Serialization Program March 20, 2014

13 Develop Detailed Business Process Mapping to Define the Touch Points for Required Events and Data Updates Tracking product movements throughout production, internal warehousing and across your supply chain (CMP/CPO sites, 3PL sites, wholesale distributor facilities, etc.) - Production: Packaging Functions, Re-Work Functions, Inventory Functions - Inventory and Distribution: Pick, Pack and Ship Functions, Receiving and Put Away Functions - Exception Management: Shipping Errors, Product Damage, etc TraceLink Inc. All Rights Reserved. ISPE Serialization Program March 20, 2014

14 Define and Manage Regulatory Reporting Triggers on Key Operational Events Event Serialized Product Attribute Regulatory Reporting Action Product Release Item Code, Market (Country) China RelationCreate Report Turkey Production (Uretim) Notification EU Countries EFPIA Report Product Commissioned Item Code, Lot, Market (Country) China RelationCreate Report Turkey Production (Uretim) Notification Sales Distribution Ship To Country China RelationCreate Report Turkey Production (Uretim) Notification EU Countries EFPIA Report (All Ser # in Lot) Brazil: - TBD China SalesWareHouseOut Report Turkey Sales (UreticiSatis) Notification Argentina Distribution Notification Turkey Export (Ihracat) Notification India Future Return Receipt Ship To Country China ReturnWareHouseIn Report Turkey Return Receipt Notification Argentina Return Received Notification, Restocked Brazil TBD Turkey Importation Notification Destruction / Decommission Country China Code Deactivation Report Turkey Deactivation (Deaktivasyon) Notification Argentina Damaged/Destroyed Notification Brazil TBD TraceLink Inc. All Rights Reserved. ISPE Serialization Program March 20, 2014

15 Network Integration and Data Exchange Preparation ISPE Professional Development Day New Brunswick, NJ

16 Identify Where Events Occur in Your Network Potential Key Touch Points By Market Required for Network Data Exchange CMOs / CPOs Serial Number Exchange Serial Number Request Serial Number Response Serial Number Disposition Events Commission, Aggregation, Ship Return, Return Receipt Destruction Logistics Service Providers Events Commission, Aggregation Ship Events Return Return Receipt Destruction / Decommission Returns Processors Government Agencies Government Reports Product Manufactured Product Imported Product Exported Product Sales / Distribution Product Receipt Product Returned Product Return Receipt Product Restocked Product Quarantined Product Expired Product Withdrawn / Recalled Product Damaged / Destroyed Product Stolen / Lost Pharma / Biopharma Companies Change of Ownership, Movement Ship (w/ Commission, Aggregation) Sale / Purchase Return / Return Receipt Change of Ownership, Movement Ship (w/ Commission, Aggregation) Sale / Purchase Return / Return Receipt Pharmaceutical Companies Wholesale Distributors Government Queries Request for Information Product/Transaction Verification TraceLink Inc. All Rights Reserved. ISPE Serialization Program March 20, 2014 Change of Ownership, Movement Ship (w/ Commission, Aggregation) Return Return Receipt Pharmacies / Hospitals

17 Identify Network Data Exchange Complexity US DQSA Example for Pharmaceutical Company Purchase Shipment Sale Pharmaceutical Companies CMO/CPOs 3PLs Repackagers Pharmaceutical Companies Wholesale Distributors Dispensers EPCIS easn?? PDF EPCIS easn PORTAL Transaction History Transaction Information Transaction Statement Shipment Aggregation Transaction History Transaction Information Transaction Statement Serialization Data Aggregation Events Serialization Data Aggregation Events Repository Pharmaceutical Company Transaction History Transaction Information Transaction Statement?? Government Officials Multiple network connections Product Production Investigation Diverse data exchange methods Serialization Aggregation Multiple data sources Data archival complexities Packaging Sites?? CMO/CPOs Data format translation issues TraceLink Inc. All Rights Reserved. ISPE Serialization Program March 20, 2014 Production

18 Build Network Partner Prioritization Framework Create a Network Profile to identify and classify supply and network partners - Network Density - Integration Status - Strategic Importance and Volume - Other? Rank order partners for deployment planning Wave 1 Wave 2 Wave 3 High Network Density Pre-Integrated Partners Strategic Partners Medium Network Density Partners Requiring Integration Medium Volume Partners Low Network Density No or Difficult Integration Low Volume Partners TraceLink Inc. All Rights Reserved. ISPE Serialization Program March 20, 2014

19 Create a Partner Network Heat Map Build a Heat Map to Review and Monitor Network Deployment Partner Information - Partner Type (CMO, WHS, 3PL, etc.) - Partner Name - Partner Location Strategic Importance - Tier 1, 2, 3 - Averaged across Customers Customers Serviced - Currently a customer partner - Expected customer partner (ie, Product Launch) Current Integration Status - Currently Integrated - Integration in process - Integration pending - No integration currently planned TraceLink Inc. All Rights Reserved. ISPE Serialization Program March 20, 2014

20 Pulling it All Together China Track and Trace Compliance Case Study ISPE Professional Development Day New Brunswick, NJ

21 China Serialization, Tracking and Reporting Model China CFDA Database Patients Pharmaceutical Company Wholesale Distributor Pharmacies / Hospitals Packaging Site CMO / CPO Data Exchanges Product Registration and Serial Number Acquisition Government Reports Government System Queries Business and Serialization Data Exchange TraceLink Inc. All Rights Reserved. ISPE Serialization Program March 20, 2014

22 Manufacturer Summary Requirements Registration and Product Master Data Configuration - Companies complete network registration form and submit to China CFDA - Receive Digital Certificate from China CFDA to use for Product Master Data Updates, Serial Number Acquisition and Government Report uploads - Configure and maintain Product Master Data Serial Number Acquisition - Download China serial numbers (EDMC codes) to support products packaged at internal and external packaging sites Serial Number Application - Apply acquired serial numbers across all levels of sales packaging - Develop and maintain aggregation relationships across serialization hierarchy China Government Reports - Commissioning / Aggregation - Sales - Return Receipts - Serial Number Deactivation - Others (Receipt of purchased product, return of purchased product, transfers ) TraceLink Inc. All Rights Reserved. ISPE Serialization Program March 20, 2014

23 China Reporting Requirements Potential Transaction Triggers for Government Reports Depending on Product Manufacture Location and Distribution Channel Transaction Manufacturer 3PL Wholesaler Retailer Activation from production Goods receiving from production Goods receiving from procurement Goods receiving from goods transfer Goods receiving from returned goods Goods dispatching for sales Goods dispatching for goods transfer Goods dispatching for returned goods Goods dispatching for disposal Goods dispatching for sampling Replacement of drug surveillance code Write-off of drug surveillance code TraceLink Inc. All Rights Reserved. ISPE Serialization Program March 20, 2014

24 Registration and Product Master Data Configuration Manufacturers maintain product master data with China system using CFDA Application Product Information - Product Code (Identifies the drug product) - Product Name - Product Sub-type Code (Sub-node of product code distinguishing different package specifications of a drug) - Approval Document Number - Preparation Type (e.g., Tablet) - Preparation Specification (e.g., 30 mg) - Package Spec (e.g., 10 vials per carton) - Physical Detail Classification Type: (e.g., 1=raw materials of stupefacient, 8=vaccine, etc.) - Package Unit List of Product Resource Codes for the Sub-type Number that will receive EDMC codes - Resource Code - Code Version (Product code version number (e.g., 81, 88) - Package Code Level (e.g., 1, 2) - Cascade Package Ratio (e.g., 1:10:50) TraceLink Inc. All Rights Reserved. ISPE Serialization Program March 20, 2014

25 China Serial Number Acquisition and Format Manufacturers download EDMC codes for each packaging level of the product using the CFDA Application - EDMC serialization code file exported from China application for drugs in the China drug catalog - Text file includes header information including Resource Code and Product Sub-type Code - Followed by list of EDMC serialization codes - Be aware that there are slight file header differences for EDL vs. non-edl drugs China EDMC Code is a 20 digit number with four distinct segments - Product Code: Drug name, dosage form, approval number, packaging specifications Code Version (codeversion): Product code version number that identifies pack level (e.g., 88=carton, etc) Resource Code (rescode): Identifies the product and associated drug name, dosage form, approval number - Serial Number: Sequential serial number associated with the product identified in the Resource Code - Check Digits: 4 random digits that make it difficult to guess the serial number assigned to the package Example: = Product code version Number that identifies the pack level [ Position 1 to 2 ] = Resource code that identifies the product [ Position 3 through 7 ] = Serial Number [ Position 8 through 16] = Check Digits [ Position 17 through 20 ] TraceLink Inc. All Rights Reserved. ISPE Serialization Program March 20, 2014

26 China EDMC Code Application The EDMC Code is applied to all levels of sales packaging - Saleable units, bundles and cases - Pallets do not receive an EDMC code Aggregation relationships for all levels of packaging must be maintained and included in China government reporting The 20 digit EDMC code is encoded on product packaging using a Code 128C one-dimensional / linear barcode - Can be directly printed on packaging or applied via sticker Style A Style B Style C With vertical orientation of phone, SMS and website for verification With horizontal orientation of phone, SMS and website for verification TraceLink Inc. All Rights Reserved. ISPE Serialization Program March 20, 2014

27 China Transaction and Reporting Sequencing Potential pharmaceutical company scenario Information Flow Physical Flow 1 China CFDA Serial Number Retrieval China CFDA Database Commission - RelationCreate 3 Shipment - SalesWarehouseOut 5 Return Receipt ReturnWarehouseIn 6 2 CFDA Serial Numbers Commission & Aggregation Decommission Code Deactivation 4 Packaging Site Pharmaceutical Company PharmaCo Warehouse Wholesale Distributor Activity (* optional) Description 1 Retrieve China Serial Numbers Serial numbers must be manually retrieved by an authorized agent of the Pharmaceutical company 2 Serial Number Exchange Share serial numbers with internal and / or external packaging sites and receive commission / aggregation info 3 Commission RelationCreate Report commissioning and aggregation information to CFDA. This typically done after Batch Release. 4 Decommission Code Deactivation Any serial numbers sampled, destroyed or removed from distribution must be reported to CFDA 5 Shipment SalesWarehouseOut Upon shipment from PharmaCo, the Shipment SalesWarehouseOut Report is generated and submitted. 6 Return Receipt ReturnWarehouseIn Upon returns to the PharmaCo, the Return Receipt ReturnWarehouseIn Report must be generated and submitted. * Shipment SalesWarehouseIn Upon shipment receipt at the PharmaCo, the Shipment SalesWarehouseIn Report is generated and submitted * Return ReturnWarehouseOut Upon return from the PharmaCo, the Return ReturnWarehouseOut is generated and submitted TraceLink Inc. All Rights Reserved. ISPE Serialization Program March 20, 2014

28 China Solution Business Process Map Product Activation Report to CFDA PharmaCo HQ PharmaCo Compliance Team PharmaCo Serialized Operations PharmaCo Serialization Contract Packager TraceLink Inc. All Rights Reserved. ISPE Serialization Program March 20, 2014

29 Global Track and Trace Solution Requirements and Readiness Checklist ISPE Professional Development Day New Brunswick, NJ

30 Global Track & Trace Solution Capabilities Capabilities Mixed/Matched Based on Regulations and Ecosystem Compliance Government Reporting Automated, harmonized creation of gov t reports Flexibility for integrated submission or manual upload Exception management and pre-submission testing Support for unique file and transmission requirements Supply Chain Track and Trace Change of ownership tracing across supply chain Product movement and transaction tracking Track and trace at lot and serialized level Verification of product identity status Operations Extensible EPCIS repository Full end-to-end aggregation management (internal, external) Strict and loose over-the-top tracking options Serialized Operations Management Warehouse & Logistics interfaces (Pick, Pack, Post Goods Issue, Shipment, Sample, etc.) Flexible triggering for tracking, tracing, verification and government reporting activities Serialization Serial Number Management Creation, import and management of serial numbers across standard GS1 and custom formats Flexible support for serial number ranges and lists Random, sequential and uniqueness options Serial Number Exchange Automated replenishment and SN allocation Global SN allocation and usage monitoring Integration flexibility to multiple line management systems and external supply partners TraceLink Inc. All Rights Reserved. ISPE Serialization Program March 20, 2014

31 Checklist for Preparation of Business and Supply Network Compliance Plan Internal Business Determine the full scope of your current business operating ecosystem (buy, sell, drop ship, transfer, repackage, dispense) Identify business process touch points and systems which trigger compliance activities (sale, shipment, receiving, etc.) Identify business systems where required product, production, transaction, partner and shipment information resides Determine OPTIONAL data potentially beneficial to capture or share for operational efficiency or business performance Product expiry, invoice/po number, etc. Analyze exception points and identify required SOPs for exception management Analyze change management risk (frequency of product change, operational change (new businesses, locations)) Supply Network Compile list of all downstream supply chain trading partners to whom you sell drug product or drop-ship product Company information, license information, key contacts Compile list of packaging sites and contract partners that produce saleable product Products produced, markets served, serialization/packaging technologies Determine if the market you serve requires potential communication with indirect trading partners Compile list of all upstream supply chain trading partners from whom you buy saleable drug product Identify the status of the drug products that you acquire Originally manufactured, purchased from direct source, purchased from indirect source, repackaged Determine internal capabilities and preferences for exchange of compliance data with external partners Survey trading partners to determine their capabilities or preferences for providing or receiving compliance data Analyze change management risk (frequency of partner change, B2B change, new market introduction, etc.) TraceLink Inc. All Rights Reserved. ISPE Serialization Program March 20, 2014

32 TraceLink Dedicated to Building Global Life Science Solutions TraceLink Life Sciences Cloud Infrastructure and Software Management Network Management Services Cloud Community and Knowledge Resources Secure, extensible Amazon AWS Cloud-based global network platform Serialization support across the end-to-end serial number lifecycle from packaging line to patient Integrated government reporting for report generation, submission and archival Network partner and subscriber connectivity, configuration and management administration platform Fully outsourced IT infrastructure, data storage and user management in elastic, native cloud environment Audited platform that is designed for pharma security considerations and validated across each software release Redundant, Active-Active environment to support disaster recovery and high availability Rapidly expanding network of suppliers and trading partners already on the network for point-and-click connection Completely outsourced partner on-boarding, integration and management services Active community of customers sharing regulatory insight, operational best practices and IT architecture learnings Diligent monitoring of US/global regulations and active leadership in GS1 standards development TraceLink Inc. All Rights Reserved. ISPE Serialization Program March 20,

33 Preparing Your IT Infrastructure, Internal Operations and Supply Network for Track and Trace Regulations ISPE Professional Development Day New Brunswick, NJ

34 Preparing Your IT Infrastructure, Internal Operations and Supply Network for Track and Trace Regulations ISPE Professional Development Day New Brunswick, NJ

35 Agenda and Speaker Agenda Global Track and Trace Requirements, Challenges and Strategies Master Data Impacts of Serialization and Track and Trace Business Process Touch Points and Layering Serialization Over Operations Speaker Brian Daleiden Vice President Marketing TraceLink Network Integration and Data Exchange Considerations Pulling It All Together: China Case Study Global Track and Trace Solution Capabilities and Preparation Checklist Q & A TraceLink Inc. All Rights Reserved. ISPE Serialization Program March 20, 2014

36 Global Track and Trace Requirements, Challenges and Strategy Development ISPE Professional Development Day New Brunswick, NJ

37 Key Global Track and Trace Requirement Themes Generate, Acquire and Manage Serial Numbers Exchange Track and Trace Information Verify Serial Numbers and Transactions Report on Products and Transactions SC Partners Gov t Agencies SC Partners Gov t Agencies SC Partners Gov t Agencies Gov t Agencies When is track and trace information required to be exchanged? - Product Manufactured / Serialized - Product Imported, Exported - Product Sales / Distributions, Product Receipt, Product Returned, Product Destruction, etc. - Product Movements What kind of track and trace information is required to be exchanged? - Event date, serial numbers, product code (e.g., GTIN, country registration code), lot number, expiration date - Seller, buyer, transaction ids (e.g., PO, delivery document, invoice) Who is required to supply and/or exchange track and trace information? - Pharma companies, CMO/CPOs, Repackagers, Kitters, 3PLs - Returns Processors, Wholesale Distributors, Pharmacies/Clinics TraceLink Inc. All Rights Reserved. ISPE Serialization Program March 20, 2014

38 Building the Global Track and Trace Analysis Chart (selective 5 country example) Requirement US China Argentina Brazil Turkey Serialization Serial Number Creator Manufacturer Government Manufacturer Manufacturer Manufacturer Serial Number Format GS1 Standard (SNI in SGTIN format) TraceLink Inc. All Rights Reserved. ISPE Serialization Program March 20, digit custom GS1 Standard 13 digit custom GS1 Standard Randomization Aggregation Products Product Scope (not incl. certain product type exceptions) Rx, All Rx, Phased Rx, Phased Rx, Phased Rx, All Supply Chain Transaction Tracking / Government Event Reporting Product Manufactured Serial Number Replaced Product Imported Product Sales / Distribution Product Transfer Product Donation / Samples Product Exported Product Receipt from Purchase Product Return Distribution Product Return Receipt Product Restocked Product Quarantined Product Withdrawn / Recalled Product Expired Product Damaged / Product Destroyed / Serial Number Deactivation Product Stolen / Lost Product Sampled (quality) Product Verification Query

39 Global Track & Trace Challenges Global Track & Trace compliance requires organizations to think differently about their supply chain networks, business processes and IT architectures Global Supply Network Integration Challenge: Integration of 100s of supply chain partners for track & trace messaging and compliance Strategy: Network Approach Big Data Challenge: Terabytes of data and 100,000s of transactions cannot be managed through traditional enterprise architectures Strategy: Native Cloud Architecture Changing Standards and Regulations Challenge: Regulations and standards are continuously evolving and will continue to evolve for the foreseeable future. Strategy: Multi-tenant and Validated Strategic Value Challenge: Drive strategic business value from track & trace compliance investments Strategy: Extensible Solution Platform TraceLink Inc. All Rights Reserved. ISPE Serialization Program March 20, 2014

40 Global Track & Trace Challenges Global Track & Trace compliance requires organizations to think differently about their supply chain networks, business processes and IT architectures Global Supply Network Integration Integration of 10s to 1000s of supply chain partners for track & trace messaging and compliance Big Data Terabytes of data and 10,000s to 1,000,000s of transactions cannot be managed through traditional enterprise architectures Changing Standards and Regulations Regulations and standards are continuously evolving and will continue to evolve for the foreseeable future Strategic Value Track and trace compliance is a huge investment, yet sets the stage for developing strategic business value through better information and supply chain visibility TraceLink Inc. All Rights Reserved. ISPE Serialization Program March 20, 2014

41 Aligning Global Requirements to Business Strategy and Operational Procedures Business Strategy Survey Strategic Elements Ensure regulatory compliance for existing, new markets Operational extensibility for future regulations IT architecture extensibility for future regulations Deployment repeatability and scalability New product launch integration Operational Goals Flexibility (meeting diverse requirements) Agility (meeting unanticipated regulations) Global standardization vs. local deployment Responsiveness (data updates, user/system access) Cost effectiveness Operational Planning Analysis - Analyze overall network for required operational event capture Manufacturing and packaging lines (internal, CMO/CPOs) Finished goods warehouses in manufacturing network Distribution network (3PLs, distribution partners, importers/agents, dispensation points) Government agencies - Identify business process requirements to meet and maintain compliance Standard business processes (sales/shipment, purchase/receiving, returns, special processes like drop shipment) Exception handling - Define Operations Requirement Flows Operationally agnostic to mandates Minimize operations impacts and change management burden Automated and/or manual compliance activities TraceLink Inc. All Rights Reserved. ISPE Serialization Program March 20, 2014

42 Impacts of Serialization and Track and Trace on Master Data ISPE Professional Development Day New Brunswick, NJ

43 Considerations for Developing a Track and Trace Master Data Management Strategy Existing Master Data What Master Data do I already have? - Product MD: GTIN, Country Drug Code (US - NDC, Germany - PZN) - Customer MD: Business name and address What systems does the current Master Data reside in? - ERP, SCM/warehouse management, CMO/CPO systems, local country partner systems What is your strategy for making the Master Data available to the track and trace systems New Master Data What new Master Data is required for global track and trace? - Product MD: China 3 levels of product identifier (product code, subtype code, resource code), new product attributes such as Code Version, Code Level and Packaging Ratio - Customer MD: Country-specific company identifiers (e.g. Brazil CNPJ, Argentina CUIT, GLN) - Partner/Channel MD: Brazil - Company identifiers, business name and address for carriers As the company serializes to meet new country mandates, how do I identify and collect new Master Data? In what systems will this new track and trace Master Data be maintained? What are the supporting track and trace systems that will be the consumers of the Master Data and which classes of Master Data is required for each? - Packaging line systems - Serialization management systems - Regulatory compliance and reporting systems TraceLink Inc. All Rights Reserved. ISPE Serialization Program March 20, 2014

44 Business Process Touch Points and Laying Serialization over Operations ISPE Professional Development Day New Brunswick, NJ

45 Determine Strategy for Layering Serialization and Event Tracking Over Logistics Processes Fully Integrated Approach Over the Top Approach Serialization Repository Serialization Repository A B C A B C Internal Distribution Network Scan / update on every internal product movement or change in form Internal Distribution Network Scan / update on receipt into network, shipment to customers and aggregation changes Determine depth of operational integration - Regulatory-driven, Operationally-driven, both Determine which business processes and operational systems need to be serialized inventory aware - WMS, Inventory Management, Shipping / Receiving, etc. Determine which regulations and processes impact the state of data in the serialization repository - E.g. Aggregation, Brazil movement tracking, etc. Minimize change management and errors by postponing updates and eliminating touch points TraceLink Inc. All Rights Reserved. ISPE Serialization Program March 20, 2014

46 Develop Detailed Business Process Mapping to Define the Touch Points for Required Events and Data Updates Tracking product movements throughout production, internal warehousing and across your supply chain (CMP/CPO sites, 3PL sites, wholesale distributor facilities, etc.) - Production: Packaging Functions, Re-Work Functions, Inventory Functions - Inventory and Distribution: Pick, Pack and Ship Functions, Receiving and Put Away Functions - Exception Management: Shipping Errors, Product Damage, etc TraceLink Inc. All Rights Reserved. ISPE Serialization Program March 20, 2014

47 Define and Manage Regulatory Reporting Triggers on Key Operational Events Event Serialized Product Attribute Regulatory Reporting Action Product Release Item Code, Market (Country) China RelationCreate Report Turkey Production (Uretim) Notification EU Countries EFPIA Report Product Commissioned Item Code, Lot, Market (Country) China RelationCreate Report Turkey Production (Uretim) Notification Sales Distribution Ship To Country China RelationCreate Report Turkey Production (Uretim) Notification EU Countries EFPIA Report (All Ser # in Lot) Brazil: - TBD China SalesWareHouseOut Report Turkey Sales (UreticiSatis) Notification Argentina Distribution Notification Turkey Export (Ihracat) Notification India Future Return Receipt Ship To Country China ReturnWareHouseIn Report Turkey Return Receipt Notification Argentina Return Received Notification, Restocked Brazil TBD Turkey Importation Notification Destruction / Decommission Country China Code Deactivation Report Turkey Deactivation (Deaktivasyon) Notification Argentina Damaged/Destroyed Notification Brazil TBD TraceLink Inc. All Rights Reserved. ISPE Serialization Program March 20, 2014

48 Network Integration and Data Exchange Preparation ISPE Professional Development Day New Brunswick, NJ

49 Identify Where Events Occur in Your Network Potential Key Touch Points By Market Required for Network Data Exchange CMOs / CPOs Serial Number Exchange Serial Number Request Serial Number Response Serial Number Disposition Events Commission, Aggregation, Ship Return, Return Receipt Destruction Logistics Service Providers Events Commission, Aggregation Ship Events Return Return Receipt Destruction / Decommission Returns Processors Government Agencies Government Reports Product Manufactured Product Imported Product Exported Product Sales / Distribution Product Receipt Product Returned Product Return Receipt Product Restocked Product Quarantined Product Expired Product Withdrawn / Recalled Product Damaged / Destroyed Product Stolen / Lost Pharma / Biopharma Companies Change of Ownership, Movement Ship (w/ Commission, Aggregation) Sale / Purchase Return / Return Receipt Change of Ownership, Movement Ship (w/ Commission, Aggregation) Sale / Purchase Return / Return Receipt Pharmaceutical Companies Wholesale Distributors Government Queries Request for Information Product/Transaction Verification TraceLink Inc. All Rights Reserved. ISPE Serialization Program March 20, 2014 Change of Ownership, Movement Ship (w/ Commission, Aggregation) Return Return Receipt Pharmacies / Hospitals

50 Identify Network Data Exchange Complexity US DQSA Example for Pharmaceutical Company Purchase Shipment Sale Pharmaceutical Companies CMO/CPOs 3PLs Repackagers Pharmaceutical Companies Wholesale Distributors Dispensers EPCIS easn?? PDF EPCIS easn PORTAL Transaction History Transaction Information Transaction Statement Shipment Aggregation Transaction History Transaction Information Transaction Statement Serialization Data Aggregation Events Serialization Data Aggregation Events Repository Pharmaceutical Company Transaction History Transaction Information Transaction Statement?? Government Officials Multiple network connections Product Production Investigation Diverse data exchange methods Serialization Aggregation Multiple data sources Data archival complexities Packaging Sites?? CMO/CPOs Data format translation issues TraceLink Inc. All Rights Reserved. ISPE Serialization Program March 20, 2014 Production

51 Build Network Partner Prioritization Framework Create a Network Profile to identify and classify supply and network partners - Network Density - Integration Status - Strategic Importance and Volume - Other? Rank order partners for deployment planning Wave 1 Wave 2 Wave 3 High Network Density Pre-Integrated Partners Strategic Partners Medium Network Density Partners Requiring Integration Medium Volume Partners Low Network Density No or Difficult Integration Low Volume Partners TraceLink Inc. All Rights Reserved. ISPE Serialization Program March 20, 2014

52 Create a Partner Network Heat Map Build a Heat Map to Review and Monitor Network Deployment Partner Information - Partner Type (CMO, WHS, 3PL, etc.) - Partner Name - Partner Location Strategic Importance - Tier 1, 2, 3 - Averaged across Customers Customers Serviced - Currently a customer partner - Expected customer partner (ie, Product Launch) Current Integration Status - Currently Integrated - Integration in process - Integration pending - No integration currently planned TraceLink Inc. All Rights Reserved. ISPE Serialization Program March 20, 2014

53 Pulling it All Together China Track and Trace Compliance Case Study ISPE Professional Development Day New Brunswick, NJ

54 China Serialization, Tracking and Reporting Model China CFDA Database Patients Pharmaceutical Company Wholesale Distributor Pharmacies / Hospitals Packaging Site CMO / CPO Data Exchanges Product Registration and Serial Number Acquisition Government Reports Government System Queries Business and Serialization Data Exchange TraceLink Inc. All Rights Reserved. ISPE Serialization Program March 20, 2014

55 Manufacturer Summary Requirements Registration and Product Master Data Configuration - Companies complete network registration form and submit to China CFDA - Receive Digital Certificate from China CFDA to use for Product Master Data Updates, Serial Number Acquisition and Government Report uploads - Configure and maintain Product Master Data Serial Number Acquisition - Download China serial numbers (EDMC codes) to support products packaged at internal and external packaging sites Serial Number Application - Apply acquired serial numbers across all levels of sales packaging - Develop and maintain aggregation relationships across serialization hierarchy China Government Reports - Commissioning / Aggregation - Sales - Return Receipts - Serial Number Deactivation - Others (Receipt of purchased product, return of purchased product, transfers ) TraceLink Inc. All Rights Reserved. ISPE Serialization Program March 20, 2014

56 China Reporting Requirements Potential Transaction Triggers for Government Reports Depending on Product Manufacture Location and Distribution Channel Transaction Manufacturer 3PL Wholesaler Retailer Activation from production Goods receiving from production Goods receiving from procurement Goods receiving from goods transfer Goods receiving from returned goods Goods dispatching for sales Goods dispatching for goods transfer Goods dispatching for returned goods Goods dispatching for disposal Goods dispatching for sampling Replacement of drug surveillance code Write-off of drug surveillance code TraceLink Inc. All Rights Reserved. ISPE Serialization Program March 20, 2014

57 Registration and Product Master Data Configuration Manufacturers maintain product master data with China system using CFDA Application Product Information - Product Code (Identifies the drug product) - Product Name - Product Sub-type Code (Sub-node of product code distinguishing different package specifications of a drug) - Approval Document Number - Preparation Type (e.g., Tablet) - Preparation Specification (e.g., 30 mg) - Package Spec (e.g., 10 vials per carton) - Physical Detail Classification Type: (e.g., 1=raw materials of stupefacient, 8=vaccine, etc.) - Package Unit List of Product Resource Codes for the Sub-type Number that will receive EDMC codes - Resource Code - Code Version (Product code version number (e.g., 81, 88) - Package Code Level (e.g., 1, 2) - Cascade Package Ratio (e.g., 1:10:50) TraceLink Inc. All Rights Reserved. ISPE Serialization Program March 20, 2014

58 China Serial Number Acquisition and Format Manufacturers download EDMC codes for each packaging level of the product using the CFDA Application - EDMC serialization code file exported from China application for drugs in the China drug catalog - Text file includes header information including Resource Code and Product Sub-type Code - Followed by list of EDMC serialization codes - Be aware that there are slight file header differences for EDL vs. non-edl drugs China EDMC Code is a 20 digit number with four distinct segments - Product Code: Drug name, dosage form, approval number, packaging specifications Code Version (codeversion): Product code version number that identifies pack level (e.g., 88=carton, etc) Resource Code (rescode): Identifies the product and associated drug name, dosage form, approval number - Serial Number: Sequential serial number associated with the product identified in the Resource Code - Check Digits: 4 random digits that make it difficult to guess the serial number assigned to the package Example: = Product code version Number that identifies the pack level [ Position 1 to 2 ] = Resource code that identifies the product [ Position 3 through 7 ] = Serial Number [ Position 8 through 16] = Check Digits [ Position 17 through 20 ] TraceLink Inc. All Rights Reserved. ISPE Serialization Program March 20, 2014

59 China EDMC Code Application The EDMC Code is applied to all levels of sales packaging - Saleable units, bundles and cases - Pallets do not receive an EDMC code Aggregation relationships for all levels of packaging must be maintained and included in China government reporting The 20 digit EDMC code is encoded on product packaging using a Code 128C one-dimensional / linear barcode - Can be directly printed on packaging or applied via sticker Style A Style B Style C With vertical orientation of phone, SMS and website for verification With horizontal orientation of phone, SMS and website for verification TraceLink Inc. All Rights Reserved. ISPE Serialization Program March 20, 2014

60 China Transaction and Reporting Sequencing Potential pharmaceutical company scenario Information Flow Physical Flow 1 China CFDA Serial Number Retrieval China CFDA Database Commission - RelationCreate 3 Shipment - SalesWarehouseOut 5 Return Receipt ReturnWarehouseIn 6 2 CFDA Serial Numbers Commission & Aggregation Decommission Code Deactivation 4 Packaging Site Pharmaceutical Company PharmaCo Warehouse Wholesale Distributor Activity (* optional) Description 1 Retrieve China Serial Numbers Serial numbers must be manually retrieved by an authorized agent of the Pharmaceutical company 2 Serial Number Exchange Share serial numbers with internal and / or external packaging sites and receive commission / aggregation info 3 Commission RelationCreate Report commissioning and aggregation information to CFDA. This typically done after Batch Release. 4 Decommission Code Deactivation Any serial numbers sampled, destroyed or removed from distribution must be reported to CFDA 5 Shipment SalesWarehouseOut Upon shipment from PharmaCo, the Shipment SalesWarehouseOut Report is generated and submitted. 6 Return Receipt ReturnWarehouseIn Upon returns to the PharmaCo, the Return Receipt ReturnWarehouseIn Report must be generated and submitted. * Shipment SalesWarehouseIn Upon shipment receipt at the PharmaCo, the Shipment SalesWarehouseIn Report is generated and submitted * Return ReturnWarehouseOut Upon return from the PharmaCo, the Return ReturnWarehouseOut is generated and submitted TraceLink Inc. All Rights Reserved. ISPE Serialization Program March 20, 2014

61 China Solution Business Process Map Product Activation Report to CFDA PharmaCo HQ PharmaCo Compliance Team PharmaCo Serialized Operations PharmaCo Serialization Contract Packager TraceLink Inc. All Rights Reserved. ISPE Serialization Program March 20, 2014

62 Global Track and Trace Solution Requirements and Readiness Checklist ISPE Professional Development Day New Brunswick, NJ

63 Global Track & Trace Solution Capabilities Capabilities Mixed/Matched Based on Regulations and Ecosystem Compliance Government Reporting Automated, harmonized creation of gov t reports Flexibility for integrated submission or manual upload Exception management and pre-submission testing Support for unique file and transmission requirements Supply Chain Track and Trace Change of ownership tracing across supply chain Product movement and transaction tracking Track and trace at lot and serialized level Verification of product identity status Operations Extensible EPCIS repository Full end-to-end aggregation management (internal, external) Strict and loose over-the-top tracking options Serialized Operations Management Warehouse & Logistics interfaces (Pick, Pack, Post Goods Issue, Shipment, Sample, etc.) Flexible triggering for tracking, tracing, verification and government reporting activities Serialization Serial Number Management Creation, import and management of serial numbers across standard GS1 and custom formats Flexible support for serial number ranges and lists Random, sequential and uniqueness options Serial Number Exchange Automated replenishment and SN allocation Global SN allocation and usage monitoring Integration flexibility to multiple line management systems and external supply partners TraceLink Inc. All Rights Reserved. ISPE Serialization Program March 20, 2014

64 Checklist for Preparation of Business and Supply Network Compliance Plan Internal Business Determine the full scope of your current business operating ecosystem (buy, sell, drop ship, transfer, repackage, dispense) Identify business process touch points and systems which trigger compliance activities (sale, shipment, receiving, etc.) Identify business systems where required product, production, transaction, partner and shipment information resides Determine OPTIONAL data potentially beneficial to capture or share for operational efficiency or business performance Product expiry, invoice/po number, etc. Analyze exception points and identify required SOPs for exception management Analyze change management risk (frequency of product change, operational change (new businesses, locations)) Supply Network Compile list of all downstream supply chain trading partners to whom you sell drug product or drop-ship product Company information, license information, key contacts Compile list of packaging sites and contract partners that produce saleable product Products produced, markets served, serialization/packaging technologies Determine if the market you serve requires potential communication with indirect trading partners Compile list of all upstream supply chain trading partners from whom you buy saleable drug product Identify the status of the drug products that you acquire Originally manufactured, purchased from direct source, purchased from indirect source, repackaged Determine internal capabilities and preferences for exchange of compliance data with external partners Survey trading partners to determine their capabilities or preferences for providing or receiving compliance data Analyze change management risk (frequency of partner change, B2B change, new market introduction, etc.) TraceLink Inc. All Rights Reserved. ISPE Serialization Program March 20, 2014

65 TraceLink Dedicated to Building Global Life Science Solutions TraceLink Life Sciences Cloud Infrastructure and Software Management Network Management Services Cloud Community and Knowledge Resources Secure, extensible Amazon AWS Cloud-based global network platform Serialization support across the end-to-end serial number lifecycle from packaging line to patient Integrated government reporting for report generation, submission and archival Network partner and subscriber connectivity, configuration and management administration platform Fully outsourced IT infrastructure, data storage and user management in elastic, native cloud environment Audited platform that is designed for pharma security considerations and validated across each software release Redundant, Active-Active environment to support disaster recovery and high availability Rapidly expanding network of suppliers and trading partners already on the network for point-and-click connection Completely outsourced partner on-boarding, integration and management services Active community of customers sharing regulatory insight, operational best practices and IT architecture learnings Diligent monitoring of US/global regulations and active leadership in GS1 standards development TraceLink Inc. All Rights Reserved. ISPE Serialization Program March 20,