Life sciences companies must comply with a number of stringent
regulations when they ship their products around the world. In this
QAD Precision Report, we look at the challenges of life sciences logistics.
Pharmaceutical, medical device and other life sciences companies have
unique responsibilities when they ship their goods around the world.
People’s health and well-being is at stake should critical products
not arrive on time. This is a challenge — it is not hyperbole to say
that delays can be fatal.
A further complication is the need for products to arrive in perfect
condition. Many life sciences products require specialist handling as
they move through carrier networks. Damage in transit may render
products ineffectual, or even harmful. As a result, life sciences
companies face unique challenges when shipping goods across town,
across country or around the world.
Temperature and Environmental Considerations
Pharmaceutical, biologics and other life sciences products can be
sensitive to fluctuations in temperature or other environmental
factors. Certain products must be kept refrigerated — sometimes at
extremely low cryogenic temperatures — as they move from the
manufacturing plant and on to hospitals, clinics, pharmacies and patients.
Vaccines, tissue samples and other biological matter as well as
certain biotechnological innovations need controlled temperatures
Sunlight, humidity and other environmental factors can also impact
the efficacy of life sciences products. Depending on the time of year,
life sciences companies may need to ensure that the carriers that they
use take different routes to specific destinations.
Shocks and vibrations can be another distinct worry. Research
suggests that for most e-commerce deliveries, boxes are dropped an
average of 17 times before the final recipient receives them.
When you ship sensitive medical devices and technology, as well as
pharmaceuticals, this cannot happen.
Correct handling is a distinct worry for logistics managers in life
sciences companies. If products are incorrectly handled at any point
of their journey to the patient, these temperature controls may not be met.
The Importance of Packaging
As a result of these temperature and environmental factors, life
sciences companies must ensure that their products are transported
using appropriate packaging. Examples of these include active and
smart packaging that can regulate temperature and/or measure
Such packaging is not necessary for all temperature sensitive life
sciences products. Gel packs or dry ice, rather than active packaging,
may be suitable for certain products.
Getting the Documentation Correct
No matter what kind of goods you ship — from t-shirts to technology —
the correct documentation must accompany the shipment. For life
sciences companies, the correct documentation is even more critical.
If critical items are stuck in customs, the health and wellbeing of
people is at stake. In addition, therapeutic agents may have short
half lives — some some, these are days, not weeks, months or years.
Therefore, delays can mean that treatments don’t reach patients while
they are still effective.
Furthermore, life sciences companies often need to include additional
documentation with their products, such as hazmat documentation or
handling instructions. For sensitive products impacted by
environmental factors, clear handling instructions with specific
information related to temperature, vibrations, sunlight and other
environmental issues that may impact a product’s efficacy are critical.
Choosing the Right Transportation Partners
As well as the correct packaging and clear, specific instructions,
life sciences companies need to work with carriers that are properly
equipped to handle their products. Carriers must handle life science
products properly at all times, as well as store and transport these
goods according to the specifications of the life science company. Not
all carriers offer such services — nor do they need to when moving
retail or consumer goods. Therefore, life sciences companies need
networks of carriers that offer specialist handling, including
hospital delivery services and cold-chain transportation.
Furthermore, transportation partners need to be able to deliver
across both urban and rural environments. Road networks and
transportation infrastructure may be lacking in remote areas, adding
further challenges to delivery. Life sciences companies need carriers
that can offer the capabilities, services levels and routes to ensure
that life saving products get where they need to be.
The Necessity of Regulatory Compliance
Given the critical nature of their work, life sciences companies need
to comply with a lot of regulations. As we have seen during the
Covid-19 global pandemic, regulations can change quickly. For example,
the US Food and Drug Administration has issued guidance for companies
making critical products to fight the pandemic that differ from the
FDA’s normal regulatory requirements.
In addition to the regulations that govern the production of certain
products, life sciences companies must also adhere to regulations
regarding the distribution of their products. These too are subject to
change. As we have seen in recent weeks, a number of countries have
sought to block the export of products used to fight the coronavirus.
In addition, some countries importing such products have made it
easier to do so.
Even under normal circumstances, adherence to global trade
regulations is complex. This is particularly true if a company has
sites around the world and ships to several different destinations.
This means that life sciences companies must adhere to a number of
different regulatory regimes and remain compliant with them all.
Procedures can change without warning, trading partners may become
subject to additional regulations or restrictions and life sciences
companies must comply. As a result, life sciences companies need to
manage rapid change in order to reduce the risk of compliance missteps.
Life sciences companies have responded to the Covid-19 pandemic in a
number of important ways. These include scaling the production of
testing kits, respirators and other critical items as well as
increasing research efforts to find a vaccine and donating supplies.
As the life sciences industry continues to assist in the fight against
the global pandemic, it underscores the importance of the correct
handling of their products. Critical goods need and deserve the most
stringent oversight and care as they move from manufacturing
facilities and on to hospitals and patients.
About QAD Precision – Trusted Global Trade and Transportation Execution
QAD Precision, a division of QAD Inc., provides industry-leading global
trade compliance, and multi carrier transportation
execution solutions from a single, integrated platform. An
ISO-certified company, QAD Precision assists companies to streamline
and transportation operations, optimize deliveries, and increase
logistics ROI. QAD Precision’s scalable and extensible solution easily
integrates with existing ERP and WMS solutions. Industry leaders in
every region of the world rely on QAD Precision’s global support
centers to leverage thousands of carrier services and manage millions
of global trade and shipping transactions every day. For more
information about QAD Precision, visit www.qadprecision.com.