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Pharmaceutical Manufacturing and Packing Sourcer
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Shippers and forwarders stress the importance of time- and
temperature-sensitive pharmaceutical products, as well as their trend to
grow in the short term. As more countries are enforcing Good
Distribution Practice (GDP) type guidelines, this will likely lead to a
rise in medicines shipped via air, due to stricter requirements. The
consensus and understanding in the air cargo logistics community is that
shippers will increasingly look for reliable and transparent
temperature-controlled solutions.
The global sourcing and
distribution model of the pharma industry favours air cargo. The current
major production locations in Europe and the US are expected to grow,
with new sites being developed in India and Latin America.
This
explains the big differences in pharma volumes between regions. For
example, looking at the European average, healthcare products comprise
3.3% of air cargo volumes. If we consider Belgium in particular, located
in the middle of one of the European pharma clusters, the industry
represents 5.7% of total air cargo volumes in the country.
Specialist Services
Since
the average market share of the healthcare segment in the total air
cargo volume is limited, specialisation is only possible in an exclusive
number of international logistical platforms. A clear trend is emerging
where airports close to pharma clusters are offering dedicated
temperature-controlled infrastructure and specific pharma handling
know-how.
This evolution also sees local logistical suppliers
taking steps to increase the quality of their services in the air
freight supply chain for pharmaceutical products. These consist of a
diverse range of commodities with different handling and storage
requirements, driving the development of a wide range of niche services.
Based
on pharma volumes handled at Brussels Airport, estimates indicate that
about 75% of products require passive cooling solutions, and about 25%
require active temperature control. Due to their complex supply chain
requirements, active solutions demand premium handling. Passive options,
on the other hand, are less costly to implement, and drive the biggest
part of the pharma volumes in air freight.
It is predicted that
the global pharma industry will spend $8.36 billion on cold chain
logistics in 2014, and is expected to expand to more than $10 billion by
2018 (1).
Mode Shift
A recent International Air
Transport Association (IATA) study has shown that a mode shift from air
to ocean is in process, including for pharmaceutical shipments (2).
However, if we take a closer look, differences exist based on the value
density of the products. The more valuable the commodity, the more
likely it is to fly by air. Air freight transport has seen larger growth
rates for the pharma sector in comparison with other industries, most
likely as a result of its high product costs.
A good example of
this trend is biopharmaceutical products, which are often extremely
highly valued. Protecting and certifying the integrity of these costly
shipments requires a substantial additional investment in cold chain
services. Close and careful temperature and humidity management during
transport is essential, but has significant supply chain implications.
Effective cold chain management with a risk-based approach has to be
introduced by logistics managers, in order to handle these products
within very specific parameters.
This carries great specialist
storage and transportation capabilities that are not limited to
pharmaceuticals; some medical devices and diagnostics products are also
condition-sensitive.
Work in Progress
The pharma
industry relies on air transport for its speed, reliability and
efficiency in delivering high-value, time-sensitive,
temperature-controlled cargo. However, while air carriers, freight
forwarders, ground handlers and airports all strive to provide quality
services, many challenges remain. Regulations are increasing around the
world; processes and specialised equipment are becoming more complex;
specific training is required to ensure staff handling products have
good pharma awareness; and multiple audits are being imposed by
companies and regulators.
Historically, there have been a huge
number of different regionally based regulations for the industry to
comply with. More recently, the EU and various other countries have
introduced GDP guidelines to ensure product integrity is maintained
throughout the supply chain. However, there is currently no global
certification standard for handling of pharmaceutical cargo, in line
with existing regulations and standards, that is internationally
recognised and implemented.
As a result, in many cases, a
mismatch remains between expectations and the services offered. There is
a lack of uniform implementation at airports throughout the entire
global supply chain. Not all stakeholders – whether at the origin or the
destination of the cold chain route – will be properly equipped to
handle temperature-controlled products.
In addition, a common
audit format is lacking, leading to lower audit effectiveness: ground
handlers and airlines are being subjected to multiple audits by various
pharma companies and freight forwarders, with different sets of
standards. This is not contributing to a smooth, effective transition
through the supply chain.
Service Optimisation
Logistical
service providers must adopt a more aligned model. This means working
collectively with all business partners and service providers to craft
supply chains for optimal end-to-end visibility and reliability.
Infrastructure Investment
So
what exactly constitutes an ideal cold supply chain? Firstly, from an
infrastructure perspective, any operator participating in the cold chain
– be it a trucker, forwarder, handling agent or airline – must have the
right temperature control technology and process in place to keep the
pharma products at the correct coldness.
This often requires
investments in temperature-controlled warehouses with a variety of
temperature zones. Zones of 15-25°C, 2-8°C and cold storage at -20°C are
most commonly used as standards in pharma air freight.
As an
alternative, high-level passive solutions or active containers can be
used to protect the temperature-sensitive cargo during transport on the
ground and in the air.
Pharma Awareness
Regardless
of the type of packaging or cool room, handling quality is primarily
impacted by the expertise of staff. Rigorous training has to be put in
place in order to make the people handling the shipments understand the
specific transport and storage requirements. Staff need to develop
pharma awareness.
Every operator should select its suppliers
based on their understanding of the industry, ensuring correct handling
at each step of the supply chain. Training of every person involved in
the handling, supervision or processing of products is key, in order to
make them aware of the impact of their job in maintaining GDP
guidelines.
Managing Complexity
The biggest
challenge, however, lies in the complexity and number of handovers from
the moment the goods are transported to the airport, to the point at
which they are handed over to the customer at the destination. If just
one single step in the logistical process is not up to standard, the
integrity of the product cannot be maintained.
Aligning and
standardising the pharma handling processes between supply chain
partners, as well as training all industry stakeholders on and around
the airport, is the only effective way to guarantee the correct handling
of pharmaceutical cargo.
Global Standard
Instead
of local regulations and procedures, it should be possible to lay down a
global standard. This will lead to an end-to-end integrated cool chain.
Rather than one individual service provider upgrading their operations
to a top-level performance, the focus should be on a community approach
where all partners within the supply chain apply the same high standards
to attain true temperature control.
IATA is best-placed to take
the initiative to develop a global air cargo industry certification
standard. Brussels Airport has worked collaboratively with IATA, in
order to develop and implement such a standard in the framework of the
IATA Center of Excellence for Independent Validators in Pharmaceutical
Handling programme (CEIV Pharma).
The CEIV Pharma certification
programme provides participants in the air cargo value chain with the
tools to ensure that they are operating to the highest standards for the
transport of what, in many cases, are life-saving drugs and medicines.
It is hoped that this will give pharma companies the confidence and
assurance that their cold chain logistics requirements are being met
through an independent certification process.
IATA and Brussels
Airport have started a pilot project to develop the programme and
certify every supplier involved with the cold chain. This community
approach covers every logistical element throughout the airport. The
Belgian regulator, Federaal Agentschap voor Geneesmiddelen en
Gezondheidsproducten, and Belgian customs – as well as the pharma
shipper community – are actively involved in the project. This
highlights the intention to build a broad consensus on the subject by
bringing together all relevant parties.
Brussels Airport has been
working with a group of 11 local stakeholders (ground handlers, freight
forwarders, truckers and airlines) to undergo the CEIV Pharma training –
bringing the cargo community together with the common goal of becoming
certified. The aim is that these businesses will be able to offer pharma
companies the competitive advantage of assuring cold chain integrity to
their clients.
For the Future
The project’s hope
is that more airports, and other supply chain providers, will also be
persuaded to undergo such training and on-site assessments. Step-by-step
routes will become certified when air cargo communities at both origin
and destination begin to align to the clear set of guidelines created by
IATA, ultimately ensuring that cold chain pharmaceutical products can
be transported in a standardised, sanitary and secure way throughout the
world.
References
1. Pharmaceutical Commerce, 29 April 2014
2. IATA World Cargo Symposium, 11 March 2014
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