Pharma Serialization: Managing the Transformation


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Serialization is a method for the pharmaceuticals industry to deter counterfeit drugs from being sold or given to medical patients; it follows precepts developed by PIE, EPCIS, and PIMMS. Implementing serialization internationally is a technical challenge for pharma, requiring coordination at every step of the products' lifecycle.

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Pharma Serialization: Managing the Transformation

  1. 1. • Cognizant 20-20 InsightsPharma Serialization:Managing the TransformationBy making the right investments in the right technology with theright business partner, the pharmaceuticals ecosystem can alleviateand hopefully eliminate the threat of counterfeit drugs to patientsafety and wellness. Executive Summary information on leveraging global best practices when implementing serialization. It covers: The global pharmaceuticals industry faces problems of counterfeiting, theft, diversion and false returns to manufacturers. The World Health • The need for serialization. Organization (WHO) estimates counterfeit drugs • Key challenges for implementation. are approximately 1% of the supply in developed • An implementation maturity model. countries and 30% to 40% in developing coun- tries. Though the 1% figure seems small, it consists • Our approach to serialization. of millions of prescriptions in the U.S. alone. Serialization regulations are in place today in Turkey, India, China, Brazil, Argentina and South Pharmaceuticals companies and governments of Korea; regulations are pending in the U.S., Canada countries worldwide believe that counterfeiting and the EU. Each nation, however, follows its own by organized crime can be reduced significantly guidelines/legislation — e.g., California’s e-pedigree by implementing product serialization. Serializa- law, U.S. FDA’s serialization guidelines, Turkey’s tion requires a comprehensive system to track serialization guidelines, China’s SFDA serialization and trace the passage of prescription drugs requirements, etc. — to curb counterfeiting and through the entire supply chain. Every product thus ensure patient safety. Despite differences should be identified by a unique serial number in in the countries’ laws, each nation’s regulations addition to the origin, shelf life and batch number. tend to be built around GS1 standards1 and are This will allow the product’s lifecycle to be traced sufficiently similar. This means pharmaceuticals from production, through distribution and finally companies, generally, can develop one program to dispensation to patients at the drugstore or that meets all global requirements. Although the hospital. GS1 format is the favored standard, International Serialization needs careful assessment, diligent Organization for Standardization (ISO), Internet planning and swift implementation. This white Engineering Task Force (IETF) and other compet- paper offers pharmaceuticals companies critical ing standards also apply to serialization. cognizant 20-20 insights | january 2013
  2. 2. Hierarchy of Benefits • Current business processes are very labor- intensive and, as a result, the price paid by the consumer for pharmaceuticals products is high. Regulatory and • The high price of prescription drugs and the Legislative relative ease of duplication and diversion make them a prime target for counterfeiters. Supply Chain Synergies • Current and pending regulatory requirements mandate that manufacturers deploy track and and Efficiencies trace tools for product movement as well as utilize authentication tools to retain their com- petitiveness. Brand Protection Serialization could result in economic benefits, as well as improved brand protection and consumer confidence in their medications.2 Anticounterfeiting Supply Chain What Drives Serialization? Serialization is not just about generating unique serial numbers for any saleable units, but also maintaning those identifications to provide Patient Safety visibility and full traceability within the supply chain. It requires collaborative action from partners throughout the supply chain for accurate recording, tracking and managing of data as theFigure 1 product moves from manufacturer to distributor to the dispensing point.Why Serialization? Serialization: Implementation ChallengesSerialization is fast becoming a necessity for Managing and administering serialization is athe pharmaceuticals industry (see Figure 2) as a complex process that leads to additional cost ifresult of the following factors: not managed properly. Key operational challenges• Ahighly complex distribution network from include: manufacturer to consumer in which products change hands as many as 10 times. • Creation of unique serialization codes for individual products during the production• The authentication of the product at various process. levels in the supply chain becomes very difficult without data sharing across the supply chain.Factors Necessitating Product Serialization Product Mix-up Counterfeiting Gray Marketing Pharmaceuticals The risk of the Manufacturing of Unauthorized Impact wrong product inferior copies of a distribution of • Loss in revenue. being put into genuine “branded” branded • Loss in profit. distribution. product labeled with products. • Loss in brand equity. the original brand • Potential lawsuits. name.Figure 2 cognizant 20-20 insights 2
  3. 3. • High-speedprinting and verification of the The serialization system is expected to perform codes generated. the following higher-level workflows: >> Production rates up to 500 units per min- • Organizing and managing serial numbers for ute, as well as dust- and vibration-prone the entire system. packaging lines makes printing and verifi- cation challenging. • Ensuring number uniqueness and randomness via integrated algorithms.• Cross-site coordination for serial generation for similar product lines. • Assigning the numbers to a batch.• Integration with enterprise systems. • Passing serial numbers on to the serialization line system (SLS) for further processing.• Optimum utilization of existing technologies/ machineries. • Maximizing the use of serialization assets that are required by most geographies.The packaging line must be revalidated asequipment is added to generate each bar code. • Ensuring that all serialization systems useEach code must be linked to product data and common capabilities: product identifica-applied to packages to enable tracking throughout tion equipment (PIE), product identificationthe supply chain. And, last: middleware management systems (PIMMS) and electronic product code information systems• Change management: Employees must be (EPCIS). All of these must be designed to trained to handle the new equipment. meet global standards and service all marketsMoreover, serialization demands that voluminous (“design once, use many”).data repositories are shared at all nodes of thepharmaceuticals supply chain. High data volumes, Our serialization solution addresses theaccuracy, security and data reliability all add to challenges at the shop floor and plant levels, andthe challenges of implementing serialization. connects to the enterprise level. Our solution deploys units of unique identification (“serializa-Serialization: Our View tion”) and creates associated unit-level electronicWe see product serialization as one of the top records that can be easily accessed via the Web orpriority activities for pharmaceuticals and smart phones in real time. Simple and ubiquitousmedical devices companies, as mandated by access to product IDs (or UIDs) and related dataregulatory agencies. provide a previously unavailable level of visibility into the production, distribution and use ofSerialization Underpinnings Strategy Material Flow GTIN: Factory Distributor Re-Packer Wholesaler Pharmacy Patient 12345678901234 Ser No. Serialize Pack 123AFDG789TR Data Flow Exp: 220912 Parent>Child Pack Data 2D Scanner Batch: 103 F Association Common Global 2D Data Matrix Common Equipment Few Operating Models from Standards Solution a Single IT& Data Model Solutions Identify Use Apply Share Manage GS1 ECC200 GS1 Identification Marchesini GS1-Compliant Data Matrix Keys & SEA Vision Information Application Barcode System Ways of WorkingFigure 3 cognizant 20-20 insights 3
  4. 4. Carton Labeling and Association Process Flow EPCIS External Machine Product Line Enterprise Systems Agencies E-code Stock Electronic Product on System Code Information Systems Generation of Batch E-codes for Product PIMMS Batch E-codes Text files per Control for Product Pack Level Manage Association Upload XML Files Files to Stock Product Identification Middleware Management System Control Print and Apply Associate Cartons Associate Cartons Associate Bundles Associate Shippers Carbon Code with Batch with Bundles with Shipper with Pallet Cartoner Bundler Case Packer PalletizerFigure 4products or their components throughout the • Evaluating current systems and processessupply chain (see Figure 4). for product serialization, by considering multiple factors such as functionality, technicalOur Methodology and Offerings elements, interfacing and cost.We advocate that pharmaceuticals companiesundertake an in-depth analysis of the current • Facilitating discussions on the future state “to be” for serialization and gathering high-levelscenario and consider multi-phase implementa- requirements.tion of serialization (see Figure 5), which entailsthe following steps:Serialization Blueprinting: Approach and Deliverables Solution Blueprinting Information Process Mapping Requirement Phases and Implementation Gathering and Gap Definition Roadmap • Gather and review • Process and systems • Review the processes • In this phase, a existing documenta- walk-through. with process solution architecture Our Methodology for Pharmaceuticals Serialization tion, work manuals. • Interview/focus group owners and look for for serialization would • Interaction with stakeholders (various meeting with key stake- holders. redundant activities, unnecessary process be developed taking into consideration the business functions and IT stakeholders • points and challenges. Identify current pain steps, role ambiguity, bottlenecks, cycle various dimensions such as data time, etc. management require- together) in an envi- sioning workshop. • Capture process handoffs between • Detailed analysis ments, packaging line • of the current docu- considerations, line Activities Identify weaknesses to uncover data people and systems. and product-specific management func- mentation. • Identify process and tionality for packing, variations. technology opportuni- warehouse and distri- • A global master • Identify inputs the and outputs of ties for improvements. bution operations. blueprint template for processes. • Our SMEs of require- develop a product serialization is developed. • packaging lines for Select processes and high level ments for the future • Present final deliver- “to-be” in discussions able and sign-offs. in-depth study. with all stakeholders. • Present final deliver- able and sign-off. • Program overview. • Process maps. • High-level • High-level solution • Workshop themes. • Gap analysis document. requirements/ Key Outputs architecture/blueprint • Measures of success. • High-level require- ments. to-be state. • Interfacing document. • Project implementa- • Individual creation/ validation of as-is requirements. tion roadmap. processes.Figure 5 cognizant 20-20 insights 4
  5. 5. Our Standard Framework We have customized consulting, POC and 1 Serialization implementation/post-implementation support offerings for SAP AIE 7.x serialization, ePedigree, track and trace, product recall and GS1 compliance requirements for pharma companies. 2 Pedigree External Third-party, e.g., Tracelink , rfExcel Manage Manage 3 System Interfaces SAP AIE/Other ERPs GS1-Compliant GS1-Compliant PIMMS-PIE, EPCIS-PIMMS, Application EPCIS-External (including pedigree) Application 4 Mobile Operations TBD • Functionality is not a key differentiator — all vendors comply with the same international standard. 5 Reporting • All major pharmaceuticals companies are moving to the same SAP modules for their business process. SAP OER/SAP BIFigure 6• Providinga high-level solution architecture, Conclusion requirements documentation and roadmap for Threats to the integrity of the drug supply are implementation (see Figure 6). likely to intensify in coming years. According toImplementation Maturity Model Peter Pitts, director of the Center for Medicinefor Serialization in the Public Interest, global drug counterfeitingFigure 7 depicts a model that we believe will help is growing at 12% to 16% a year, and, in 2010,in identifying an organization’s degree of maturity generated as much as $75 billion in worldwidefor a successful serialization implementation. revenues. “It is shocking to realize that in someAscending Serialization’s Learning Curve Level 1 Level 2 Level 3 Level 4 Level 5 Projects are managed Projects are managed A centrally managed Central PMO with End-to-end PMO from at an individual level at a unit level with PMO with well- active management blueprinting to global Governance PMO and and the synergies are no centralized PMO. defined processes for site-specific rollout with proactive not exploited. Projects Slightly consolidated, and solutions, from variations and scope planning, detailed change are managed as a no consideration for blueprinting to variations with clear and risk management, best discrete unit. variations. deployment across communication practices and continuous locations. plan and change improvement included. management. Basic solution Configuration is Data and packaging Data management Adaptable, flexible Configuration Management configuration set-up repeatable, but needs line configurations and line-specific configurable serialization that lacks flexibility and detailed study and are well-defined and configurations are solution enabling support adaptation. design modification to designed with elements captured at the of wide variety of packaging the code base. that can be assembled planning stage and line functions. and realigned to global templates are quickly accommodate in place. changing demands. Solution deployment Solution can be Deployment plan is Deployment plans Global development Deployment is planned for only modified and installed well-defined with all support multiple playbook is in place and the pilot line with no in similar packaging common site and serialization and the solution is readily Rapid replicable code base. lines, but not readily packaging-line-specific coding requirements installable, replicable and repeatable and the serialization variations with manageable easily upgradable across timelines are not with actionable timelines. packaging lines and predictable. timelines. locations.Figure 7 cognizant 20-20 insights 5
  6. 6. Quick TakeE-code Serialization for a Pharma MajorWe helped in implementing serialization for a • Managing and monitoring the changeleading global pharmaceutical major. management plan.Scenario • Managing IT risks and issues.• Client wanted to implement e-code serialization • Providing regular status reports to IT which uses common capabilities (PIE, PIMMS, management. EPCIS) and is designed to meet global standards Benefits Attained and service all markets. • Track-and-trace products deployed from the• A complete solution was required to address point of packaging to the pharmacy. data management and packaging functions. • Reduced the risk of counterfeit products beingOur Role dispensed.• Ensuring client standards are met through • Expired products now detected automatically. engaging appropriate architecture, EIS and quality resources at the right time. • Performs product recalls more effectively and efficiently.• Engaging with other teams to deliver project • Delivers the right product to the right patient. of the world, somewhere between 30% manufacturers can realize even greater benefitsand 50% of drugs to treat serious diseases are such as total supply chain visibility and reducedactually counterfeit,” said Food and Drug Admin- product recalls, over and above what is requiredistration commissioner Margaret Hamburg, by regulatory compliance.who added that the problem “is growing everyday.”3 Meanwhile, Joe Ringwood, chief operating Making the right investments in the rightofficer of Systech International, noted: “Phar- technology with the right business partner canmaceutical counterfeiting is a global problem only help the pharmaceuticals ecosystem —that is growing rapidly.”4 As a result, serialization manufacturers, wholesalers, distributors andhas the potential to be a very efficient tool for pharmacies — alleviate and eventually eliminatepharmaceuticals leaders in the fight against the threat of counterfeited drugs to patient safetycounterfeiting. and wellness. Successful serialization will be a key differentiator and a clear competitive advantageManaging the transformation is a crucial and for pharmaceuticals companies in the near termessential part of the overall serialization imple- and over the long haul as drug counterfeiting ismentation strategy. By choosing a reliable partner reduced to a distant memory.and developing a diligent implementation plan, cognizant 20-20 insights 6
  7. 7. Footnotes1 GS1 is the international standards group whose healthcare component is working on pharmaceuticals product tagging standards. The GS1 system of standards is the most widely used supply-chain standards system in the world. It is composed of four key standards: barcodes (used to automatically identify items), eCom — electronic business messaging standards allowing automatic electronic transmission of data, global data synchronization standards (GDSN), which allow business partners to have consistent item data in their systems at the same time and EPCglobal which uses RFID technology for real-time item tracking. For more information: “Mass Serialization in the European Pharmaceuticals Market,” Frost & Sullivan, page 23.• World Health Organization, “Medicines: Counterfeit Medicines,” Fact sheet No. 275 (January 2010), available at• Pharmaceuticals and Packaging News (PMP News), “Combating Counterfeits,” Sept. 9, 2011, available at• Center of Medicines in the Public Interest, “Counterfeit Drugs and China NEW,” available at• Pharmaceuticals and Packaging News (PMP News), “Best Practices in Serialization,” June 18, 2009, available at• GS1 Healthcare Reference book 2011/2012: Reference_Book_2011-2012.pdf.• Life Science leader “The Long Road to Serialization and Track and Trace,” March 27, 2012, http://www.• Life Science Leader “Planning Serialization for Pharmaceuticals Manufacturer”: Pharmaceuticals-manufacturers.• EFPIA “Coding and Identification of Products: Towards Safer Medicines Supply”: Useful Links••••• cognizant 20-20 insights 7
  8. 8. About the AuthorsAravindhan Ramakrishnan is a Senior Consultant within Cognizant Business Consulting. He has extensiveexperience across life sciences, energy and consumer goods industries. As an operations and technologyexpert Aravindhan has been working with clients to help them transform their businesses. He focuseson strategy development and implementation, technology strategy, organization design, operationalexcellence and innovation management. Prior to Cognizant, Aravindhan was employed by IBM’s Strategy& Transformation Practice and by Honeywell. He holds a bachelor’s degree in engineering and an M.B.A.Aravindhan can be reached at Yasmin is a Consultant within Cognizant Business Consulting. She has over one year of experiencein management consulting and business development, and has supported projects across variousindustries: life sciences, chemicals and consumer goods. She holds a bachelor’s degree in chemical engi-neering and an M.B.A. from NITIE, Mumbai. Ghazala can be reached at CognizantCognizant (NASDAQ: CTSH) is a leading provider of information technology, consulting, and business process out-sourcing services, dedicated to helping the world’s leading companies build stronger businesses. Headquartered inTeaneck, New Jersey (U.S.), Cognizant combines a passion for client satisfaction, technology innovation, deep industryand business process expertise, and a global, collaborative workforce that embodies the future of work. With over 50delivery centers worldwide and approximately 150,400 employees as of September 30, 2012, Cognizant is a member ofthe NASDAQ-100, the S&P 500, the Forbes Global 2000, and the Fortune 500 and is ranked among the top performingand fastest growing companies in the world. Visit us online at or follow us on Twitter: Cognizant. World Headquarters European Headquarters India Operations Headquarters 500 Frank W. Burr Blvd. 1 Kingdom Street #5/535, Old Mahabalipuram Road Teaneck, NJ 07666 USA Paddington Central Okkiyam Pettai, Thoraipakkam Phone: +1 201 801 0233 London W2 6BD Chennai, 600 096 India Fax: +1 201 801 0243 Phone: +44 (0) 20 7297 7600 Phone: +91 (0) 44 4209 6000 Toll Free: +1 888 937 3277 Fax: +44 (0) 20 7121 0102 Fax: +91 (0) 44 4209 6060 Email: Email: Email:©­­ Copyright 2013, Cognizant. All rights reserved. No part of this document may be reproduced, stored in a retrieval system, transmitted in any form or by anymeans, electronic, mechanical, photocopying, recording, or otherwise, without the express written permission from Cognizant. The information contained herein issubject to change without notice. All other trademarks mentioned herein are the property of their respective owners.