Globalization in Life Sciences

The life sciences industry has always been global in nature, with hundreds of pharmaceutical and biopharmaceutical manufacturers and thousands of distribution and dispensation trading partners located around the world. In recent years though, financial performance and competitive pressures have increased the emphasis to open new markets, reorganize trade channels, and seek lower cost operational locations. These changes are drastically affecting all segments of the business, from R&D and clinical trials to manufacturing and distribution.

For companies participating in the global supply chain, globalization trends such as these are opening up several issues that challenge an efficient and profitable operation:

• Global Manufacturing.  Global pharmaceutical companies are expanding their manufacturing presence in low-cost regions, increasing internal planning and operational complexity.
• International Material Sourcing.  Diversified sources of manufacturing inputs and excipients feed the product process, challenging quality control and chain of custody tracking in the case of adverse events.
• Outsourced Operations.  Operations are become increasingly streamlined as non-core functions such as distribution, packaging, and even manufacturing are being outsourced.
• Global Compliance and Oversight.  Regulatory requirements for product handling and identification vary widely by region. In addition, quality inspection regimes for finished products and active ingredients are not uniform. Both issues pressure business planning and operational flexibility.
• Cold Chain Protection.  Ensuring compliance with Good Storage and Distribution Practices has become more challenging as temperature-sensitive products traverse multiple countries and spend more time in transit and flowing through customs barriers.

Global Serialization Issues

Serialization requirements are impacting many corporate globalization decisions. Programs to require identification of drug products at the case pack or saleable unit level have been growing across multiple countries. Driven by a diverse set of goals, such as track and trace of products, control of reimbursement fraud, or monitoring of consumption and public health care expenditure, these programs create operational and IT challenges throughout an organization.

The global serialization challenge becomes one of striving for a single global plan in the face of many local and regional variations, as well as managing the uncertainty due to new and anticipated requirements.

Serialization programs in the United States are just starting to emerge. Case-level serialization initiatives were begun previousely as part of risk-based product security programs. Item-level or mass serialization is just starting to advance forward in the industry, driven by both US requirements such as California mandates and FDA programs, as well as by European requirements.

In Europe, multiple countries already have requirements for unit-level identification, but the drivers and information needs vary widely.  

• Italy requires that a sales pack must contain a unique "bollini" that includes a product license number (AIC code) and a separate sequential number to combat reimbursement fraud.
• Belgium mandates that each reimbursable pack include a sequential code, constructed from four different elements including an APB product identification number, that is significantly different in form from the Italian bollini.
• Greece requires both a National Registration Number as well as a sequential number.
  
• Ireland serialization requirements focus on hemophilia products.
  
• Spain is just starting to define their specific approach to serialization.
• Turkey is the first country outside the USA that has targeted transport package serialization in addition to saleable unit serialization. Turkey has unveiled product identification and labeling requirements that include a data matrix barcode for prescription drugs, samples, hospital packaged products, and formulas for medicinal purposes and over-the-counter drugs. The Turkish Ministry of Health has defined requirements, drafted guidelines, and identified specific industry standards to be used for items as well as transport packages (cases, cartons, etc.).
  

The strategic and operational decisions that companies in the global life sciences supply chain make in response to these serialization and product identification requirements will have dramatic impact on business performance.

Key Challenges for Global Serialization Programs

For companies building strategies and operational plans for global serialization, this diverse regulatory and technical landscape presents several challenges for Operations and IT leaders. Just a few of the key question include:

• Serial number construct and format  Will a manufacturer be able to create one single serial number identification scheme, including construct and format, for a given product or will multiple different schemes be required based on where the product is intended for to? What characteristics should be considered when creating the identification system, such as uniqueness, capacity, extensibility, privacy, persistency, and global standardization support? As a wholesale distributor or pharmacy, will I be able to understand the serial numbers of received products from a single manufacturer and distinguish these numbers from all of my other suppliers?
• Data carrier and label  With selection of the identification system, what is the appropriate data carrier (barcode, RFID) to use? Will the data carrier have the capacity needed to hold the serialization information? What cost impacts will the application of the carrier have on unit profitability? Is the current labeling system in place extensible to support carrier selection? If multiple carriers are needed based on regional requirements, will manufacturing and packaging lines be able to efficiently adapt? If my company is downstream in the supply chain, how can my receiving and inventory operations adapt to the potential for dozens of different carriers and labels coming inbound from my suppliers?
• Packaging  As uniquely serialized products are packaged into cases and other organizational units, what provisions need to be made for channel scanning, particularly in the case of non-line-of-sight data carriers? Is inference both a technical and a regulatory possibility or will case packs need to be broken?   
• Trade network coordination  At the same time my company is making crucial numbering, labeling, and packaging decisions, my trading partners are making their own independent decisions on support for these same issues. What kinds of coordination and communication processes should I put into place to ensure both interoperability and synchronization of serialization programs?

SupplyScape Solutions for Globalization Support

Companies seeking support analyzing these challenging global serialization and integrated track and trace solution questions can look to SupplyScape for help with all phases. Selected solutions that SupplyScape provides to assist companies in the life sciences with these issues include:

Strategy Consulting and Planning
SupplyScape’s Strategic Consulting helps companies maximize business opportunity and reduce compliance risk as they design and invest in global serialization and international supply networks. Our strategy teams have deep expertise in serialization technology, regulatory and standards analysis, and operational planning derived from years of field experience and dozens serialization engagements.  

Global Supply Chain Collaboration
SupplyScape’s Nexus provides a network-based data sharing and business collaboration service platform that drastically reduces the friction of connecting companies together, even in diverse serialization and operational environments.

Serialization and Serialized Product Pedigree Solutions
SupplyScape’s Product Security suite delivers an integrated serialized product and pedigree track and trace solution for companies at all points in the supply chain from manufacture and packaging to dispensation. Our business process applications such as these are designed to drive maximum operational benefit and business value creation from costly investments in serialization infrastructures.