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Bridging Life Sciences and Healthcare
Table 2: Problems and Solutions for Manufacturing Genealogy Table 4: Problems and Solutions for Strategic
Assessment and Response
Desired Business Expected Business
Pain Points Capabilities Benefits
Desired Business Expected Business
Inability to maintain link Maintaining link between Manufacturing
Pain Points Capabilities Benefits
between serialized components, serialized components, raw traceability provides
Inability to quickly asses Ability to combine sales orders Lower lead times and
raw materials, manufacturing materials, other inputs, and ability to investigate
the scope of a problem: with information from business administration costs with
practices, labor, machines finished product for traceability production issues
exact nature of product partners to build product map automated collaboration
and finished product for all the way to the root
affected as quickly as possible processes
bi-directional traceability cause, whether
current ownership
component/raw material
cost of recall
batch/machine/labor
Inaccurate recall scope Software-supported standardized Greater customer
Difficulty determining root Maintenance of quality- Faster and more accurate
affects customer processes that can deal with satisfaction and more
causes of quality issues and materials/inputs- investigation of issues,
satisfaction and unexpected events stable brand value with
owing to poor documentation related information more targeted
brand value better ability to determine
of product genealogy during production containment of problems
need to recall product,
Data inaccuracy caused Accurate recording of control Accurate information
scope of recall, and the
by manual rather than and production information for provides insights into
best course of action
automated standardized every production run business and helps
Slow response to Accurate determination of Good, consistent response
processes in optimization
unexpected quality or scope of recall with standard processes
Non-compliance with Easier compliance with good Production visibility
compliance issues
manufacturing regulations manufacturing practices (GMPs) facilitates regulatory
Unaligned metrics across ‘Balanced scorecard’ supply Overall supply chain
and best practices and other regulations compliance during
supply chain silos chain performance incentives performance improved
manufacturing
with appropriately
aligned incentives
Table 3: Problems and Solutions for Supply Chain
Tracking and Tracing
relationship with physicians, and ensure patients and health workers of
the authenticity of their medication.
Desired Business Expected Business
Pain Points Capabilities Benefits
Serialization and track-and-trace technologies have the potential to
Prevalent and growing Advanced product authentication Detect and reduce
significantly lower errors with medication, reduce associated adverse drug
counterfeiting and diversion woven in along all steps in counterfeiting and
events, improve levels of patient safety, and ensure medication compliance.
of products the logistic processes diversion, protecting the
Specific advantages include:
brand and customers’
health
Lack of upstream/ Full collaborative visibility Faster response times and
eliminating drug dispensing errors; ensuring right patient, right drug, right
downstream visibility and tracking of goods for increased customer
dose, right route, and right time;
to stock positions and both forward and reverse satisfaction from
improving patient safety and medication compliance;
in-transit inventory along logistics through business collaborative visibility,
enhancing quality control;
the supply chain partners reduced administrative improving clinical decision support;
costs during recalls/returns proactively addressing product expiration;
High discard rate of product Realtime monitoring and Reduced spoilage of
improving inventory control and billing; and
due to spoilage, damage, supply chain visibility enable product due to poor
improving nurse satisfaction and productivity.
and expiration fast response times to conditions while in
changes in the condition transit, lot expiration
Case Study—Jena University Hospital
of shipments or damage
The Jena University Hospital in Germany is at the forefront of this innovation
Delays and increased Employing a ‘balanced scorecard’ Incentives are aligned to
response time for recalls supply chain performance improve overall supply
and a good example of this new ability to ‘bridge the chasm.’ Jena Hospital has
incentive chain performance
deployed serialization capabilities from SAP, which are integrated with its
electronic medical records (EMRs) system to accurately track and trace unit
delivering high-quality pharmaceutical products to improve human health doses of prescribed drugs from the hospital pharmacy to the patient’s bedside.
and maintain their margins, pharmaceutical firms need to confront these Each unit dose has a radiofrequency identification (RFID) tag, and consequently
challenges and find a way to contain costs while delivering value. leaves an auditable trail of its progress to ensure that each patient receives the
Visionary pharmaceutical companies are therefore seeking ways and right drug in the right dosage at the right time. To eliminate human error as
means of improving their business processes, for example by completely as possible, Jena Hospital uses steel containers on an automatic,
manufacturing the generics themselves upon patent expiry, or delivering robotic internal transport system, also equipped with RFID tags. The drug is
value-added services to ‘bridge the gap.’ By implementing serialization administered to the patient—identified by an RFID bracelet worn by the
and track and trace for their products, which extend beyond the retail patient—by the attendant nurse as prescribed by the physician. Furthermore,
pharmacy into the hospital pharmacy, the pharmaceutical firm is giving the system can record all medication automatically in the patient’s EMR,
itself fresh opportunities to reinforce its brands, build a stronger including details about type, quantity, and time of medication. Jena Hospital
14 PHARMACEUTICAL SERIALIZATION & AUTHENTICATION