Marys Medicine

Pharma serialization: managing the transformation

• Cognizant 20-20 Insights Pharma Serialization: Managing the TransformationBy making the right investments in the right technology with the right business partner, the pharmaceuticals ecosystem can alleviate and hopefully eliminate the threat of counterfeit drugs to patient safety and wellness.
Executive Summary information on leveraging global best practices The global pharmaceuticals industry faces when implementing serialization. It covers: problems of counterfeiting, theft, diversion and • The need for serialization.
false returns to manufacturers. The World Health 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- • Our approach to serialization.
tries. Though the 1% figure seems small, it consists 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 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 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.
• The high price of prescription drugs and the relative ease of duplication and diversion make them a prime target for counterfeiters.
• Current and pending regulatory requirements Supply Chain Synergies mandate that manufacturers deploy track and and Efficiencies trace tools for product movement as well as utilize authentication tools to retain their com-petitiveness.
Serialization could result in economic benefits, as well as improved brand protection and consumer confidence in their medications.2 Anticounterfeiting What Drives Serialization? Serialization is not just about generating unique serial numbers for any saleable units, but also maintaning those identifications to provide 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 the product moves from manufacturer to distributor to the dispensing point.
Why Serialization? Serialization: Implementation Challenges
Serialization is fast becoming a necessity for Managing and administering serialization is a the pharmaceuticals industry (see Figure 2) as a complex process that leads to additional cost if result of the following factors: not managed properly. Key operational challenges • A highly complex distribution network from manufacturer to consumer in which products • Creation of unique serialization codes for change hands as many as 10 times.
individual products during the production • The authentication of the product at various levels in the supply chain becomes very difficult without data sharing across the supply chain.
Factors Necessitating Product Serialization Manufacturing of inferior copies of a • Loss in revenue.
genuine "branded" • Loss in profit.
product labeled with • Loss in brand equity.
the original brand • Potential lawsuits.
cognizant 20-20 insights • High-speed printing 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 as equipment is added to generate each bar code. • Ensuring that all serialization systems use Each code must be linked to product data and common capabilities: product identifica- applied to packages to enable tracking throughout tion equipment (PIE), product identification the 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 markets Moreover, serialization demands that voluminous ("design once, use many").
data repositories are shared at all nodes of the pharmaceuticals supply chain. High data volumes, Our serialization solution addresses the accuracy, security and data reliability all add to challenges at the shop floor and plant levels, and the 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 electronic We see product serialization as one of the top records that can be easily accessed via the Web or priority activities for pharmaceuticals and smart phones in real time. Simple and ubiquitous medical devices companies, as mandated by access to product IDs (or UIDs) and related data provide a previously unavailable level of visibility into the production, distribution and use of Distributor Re-Packer Wholesaler Pharmacy Patient 12345678901234Ser No. Common Equipment Few Operating Models from a Single IT& Data Model GS1 Identification cognizant 20-20 insights Carton Labeling and Association Process Flow Electronic Product Generation of Batch Code Information Systems E-codes for Product Manage Association Upload XML Files Product Identification oduct Line Co Middleware Management System Associate Cartons Associate Cartons Associate Bundles Associate Shippers products or their components throughout the • Evaluating current systems and processes supply chain (see Figure 4).
for product serialization, by considering multiple factors such as functionality, technical Our Methodology and Offerings elements, interfacing and cost.
We advocate that pharmaceuticals companies • Facilitating discussions on the future state "to undertake an in-depth analysis of the current be" for serialization and gathering high-level scenario and consider multi-phase implementa- tion of serialization (see Figure 5), which entails the following steps: Serialization Blueprinting: Approach and Deliverables Solution Blueprinting and Implementation • Gather and review • Process and systems • Review the processes • In this phase, a existing documenta- solution architecture tion, work manuals.
• Interview/focus group owners and look for for serialization would • Interaction with meeting with key stake- redundant activities, be developed taking stakeholders (various unnecessary process into consideration the business functions steps, role ambiguity, various dimensions • Identify current pain and IT stakeholders bottlenecks, cycle points and challenges.
together) in an envi- management require- • Capture process ments, packaging line sioning workshop.
• Detailed analysis handoffs between considerations, line Identify weaknesses people and systems.
and product-specific of the current docu- Identify process and tionality for packing, technology opportuni- warehouse and distri- • A global master ties for improvements.
bution operations.
blueprint template for and outputs of the product serialization • Our SMEs develop a high level of require- is developed.
Select processes and ments for the future • Present final deliver- packaging lines for "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 solution • Workshop themes.
• Gap analysis document.
architecture/blueprint to-be state.
Measures of success.
• High-level require- • Project implementa- tion roadmap.
• Individual creation/ validation of as-is processes.
cognizant 20-20 insights Our Standard Framework We have customized consulting, POC and implementation/post-implementation support offerings for serialization, ePedigree, track and trace, product recall and GS1 compliance requirements for pharma companies. External Third-party, e.g., Tracelink , rfExcel System Interfaces SAP AIE/Other ERPs PIMMS-PIE, EPCIS-PIMMS, EPCIS-External (including pedigree) Mobile Operations • Functionality is not a key differentiator — all vendors comply with the same international standard. • All major pharmaceuticals companies are moving to the same SAP modules for their business process. • Providing a high-level solution architecture, 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 to Implementation Maturity Model Peter Pitts, director of the Center for Medicine for Serialization in the Public Interest, global drug counterfeiting Figure 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 worldwide for a successful serialization implementation.
revenues. "It is shocking to realize that in some Ascending Serialization's Learning Curve 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 active management blueprinting to global 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 variations with clear and risk management, best discrete unit.
deployment across practices and continuous Configuration is Data and packaging Adaptable, flexible 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 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 changing demands.
Solution deployment Deployment plan is Deployment plans Global development 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 serialization and the solution is readily replicable code base.
lines, but not readily packaging-line-specific coding requirements installable, replicable and repeatable and the serialization variations easily upgradable across timelines are not packaging lines and cognizant 20-20 insights Quick Take
E-code Serialization for a Pharma Major We helped in implementing serialization for a • Managing and monitoring the change leading global pharmaceutical major.
management plan.
• Managing IT risks and issues.
• Client wanted to implement e-code serialization • Providing regular status reports to IT which uses common capabilities (PIE, PIMMS, 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 being • Ensuring client standards are met through • Expired products now detected automatically. engaging appropriate architecture, EIS and • Performs product recalls more effectively and quality resources at the right time.
• Engaging with other teams to deliver project • Delivers the right product to the right patient. parts of the world, somewhere between 30% manufacturers can realize even greater benefits and 50% of drugs to treat serious diseases are such as total supply chain visibility and reduced actually counterfeit," said Food and Drug Admin- product recalls, over and above what is required istration commissioner Margaret Hamburg, by regulatory compliance.
who added that the problem "is growing every day."3 Meanwhile, Joe Ringwood, chief operating Making the right investments in the right officer of Systech International, noted: "Phar- technology with the right business partner can maceutical counterfeiting is a global problem only help the pharmaceuticals ecosystem — that is growing rapidly."4 As a result, serialization manufacturers, wholesalers, distributors and has the potential to be a very efficient tool for pharmacies — alleviate and eventually eliminate pharmaceuticals leaders in the fight against the threat of counterfeited drugs to patient safety and wellness. Successful serialization will be a key differentiator and a clear competitive advantage Managing the transformation is a crucial and for pharmaceuticals companies in the near term essential part of the overall serialization imple- and over the long haul as drug counterfeiting is mentation strategy. By choosing a reliable partner reduced to a distant memory.
and developing a diligent implementation plan, cognizant 20-20 insights 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 inf.
2 "Mass Serialization in the European Pharmaceuticals Market," Frost & Sullivan, page 23. References• World Health Organization, "Medicines: Counterfeit Medicines," Fact sheet No. 275 (January 2010), • Pharmaceuticals and Packaging News (PMP News), "Combating Counterfeits," Sept. 9, 2011, available • 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, • GS1 Healthcare Reference book 2011/2 • Life Science leader "The Long Road to Serialization and Track and Trace," March 27, 2 • Life Science Leader "Planning Serialization for Pharmaceuticals Manufacturer": • EFPIA "Coding and Identification of Products: Towards Safer Medicines Supply": Other Useful Links• • • • • cognizant 20-20 insights About the AuthorsAravindhan Ramakrishnan is a Senior Consultant within Cognizant Business Consulting. He has extensive experience across life sciences, energy and consumer goods industries. As an operations and technology expert Aravindhan has been working with clients to help them transform their businesses. He focuses on strategy development and implementation, technology strategy, organization design, operational excellence 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 Ghazala Yasmin is a Consultant within Cognizant Business Consulting. She has over one year of experience in management consulting and business development, and has supported projects across various industries: 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 re. About 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 in Teaneck, New Jersey (U.S.), Cognizant combines a passion for client satisfaction, technology innovation, deep industry and business process expertise, and a global, collaborative workforce that embodies the future of work. With over 50 delivery centers worldwide and approximately 150,400 employees as of September 30, 2012, Cognizant is a member of the NASDAQ-100, the S&P 500, the Forbes Global 2000, and the Fortune 500 and is ranked among the top performing and fastest growing companies in the world. Vollow us on Twitter: Cognizant.
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