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Bridging Life Sciences and Healthcare
Serialization as a Bridge Between Life Sciences and Healthcare—
Track and Trace from the Plant to the Pharmacy to the Patient Bedside
a report by
Mandar Paralkar
1
and Andy Dé
2
1. Solutions Manager, Industry Solutions Management; 2. Senior Director, Industry Solutions Marketing, SAP for Life Sciences, Healthcare Sector
Serialization will enable each individual unit of a drug to be tracked and specifically, this includes documenting and maintaining links surrounding
traced all along its journey from the manufacturing plant to the pharmacy. the end product, the associated business context, and the manufacturing
It is increasingly becoming imperative for pharmaceutical manufacturers to process and inputs. The ideal system will automatically record and
introduce serialization: not only is there an increasing density of emerging maintain the genealogy of a product, associating it with the raw
mandates in this arena that must be complied with, but also implementing materials and serialized components included, labor employed, machines
such a strategy facilitates superior supply chain visibility and, perhaps more used, and all of the manufacturing processes involved to provide full
importantly, helps to combat counterfeiting and diversions. Like Cephalon traceability and visibility. A typical series of business problems (pain
(see pages 9–11), a number of industry leaders in the pharmaceutical and points) and the related end-points and benefits is shown in Table 2. In
healthcare industry are seizing these opportunities and, in doing so, giving order to realize these business benefits, there are a number of important
themselves the potential to realize significant returns on their information capabilities required:
technology (IT) investments. The crucial element of any serialization strategy
is to employ a holistic approach: deploying an end-to-end IT-enabled manufacturing traceability to track production, batches, business context,
business process across not only manufacturing, distribution, and logistics and serialization from enterprise planning to manufacturing execution;
arenas, but also encompassing product safety and compliance with industry serialization at point of production to ensure item-level traceability across
standards, to track and trace drugs from the plant floor to the pharmacy. the supply chain, higher standards of quality control, and improved
regulatory compliance; and
Company-wide Challenges product genealogy to fully document material and component
There are many critical capabilities that must be addressed to enable a transformation into end products by maintaining supplier’s batch or serial
comprehensive solution for serialization and track and trace that is compliant number information for raw materials and components and linking it with
with GS1/EPC Information Services (EPCIS) standards. These capabilities should finished products and business documents, allowing for traceability across
be assessed in the context of the various challenges inherent in the multiple business partners.
lines of businesses within a pharmaceutical company, including manufacturing,
warehousing, distribution, and product safety, as shown in the end-to-end Supply Chain Tracking and Tracing
process schematic in Figure 1. Table 1 expands on these challenges. There are As a product moves along the supply chain, there are several important
a number of benefits to taking a holistic approach to serialization and track and processes that must take place: its authentication is checked at each step,
trace, and in the process enabling the different lines of businesses to address information is updated on its whereabouts, and its condition status is
these challenges. When considering implementing an end-to-end solution, one monitored, such that if it is found to be damaged or held in inappropriate
approach is to assess the desired capabilities for the three key areas of conditions, an exception can be triggered. Typical problems versus desired
manufacturing, supply chain distribution, and strategy. By analyzing these capabilities and expected business benefits are outlined in Table 3. Track and
capabilities in the context of the expected business benefits versus the current trace in the supply chain has several implications:
business shortfall, a clearer picture can be derived.
integration of automatic identification technologies for tracking,
Manufacturing Genealogy authentication, and condition monitoring in the warehousing and
The critical functions that serialization and track and trace must perform logistics process;
within the manufacturing arena are related to a product’s genealogy; logistics management and monitoring enhances enterprise-level logistics
processes with automatic identification-based technologies, which are
integrated with the existing processes to provide an extensible platform for
Mandar Paralkar is Solutions Manager at IBU Life Sciences and
Healthcare at SAP, based in Newtown Square, Philadelphia. In
future process enablement;
this role, he is responsible for the roll-out of new products and automatic identification technologies used for serialization enable item-
solutions to industry customers and roll-in requirements back to
level and hierarchical product tracking, authentication, and visibility across
product development. Mr Paralkar holds a BSc in mechanical
engineering from Mumbai University, India.
the supply chain—within and beyond company boundaries.
Strategic Problem Assessment and Response
A crucial part of any business is the ability to collect high-quality data, analyze
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