Pharmaceutical Outsourcing Q2 2024 - 11

SUPPLY CHAIN
Glancing Back at the Last Decade
Sponsors are looking for more value, lower cost, higher performance,
and above standard quality. Many new medical products are being
launched at cold and ultra-low temperatures, and distribution wants
a choice of shipping solutions.
Temperature excursions and deviations continue to be a problem in
the shipping environment.
The use of thermal modeling has become more accurate and a
common tool that avoids expensive lab testing and/or delays due to
lab chamber schedules.
Decision-making has expanded the meaning of total cost of
operations (sometimes called total cost of ownership). This includes:
the shipping container, freight, utilities, storage (space) costs,
warehousing, indirect labor, reduction of temperature excursions,
scrap, returns, and environmental sustainability.
RU shipping system programs are growing in size, type of services
and levels of quality. Only a few players are mature, and many
players are learning the difficulties within the GMP/GDP business
model. Currently, the passive reusable (RU) shipper industry has no
testing standard.
Artificial intelligence (AI) applications are beginning to simplify tasks,
greatly expanding the AI user population to less technical users. This
will open new areas of opportunity.
Looking Into the Next Decade
The industry is trending towards outsourcing all distributionrelated
activities (including the product packing) into the shipping
solution. It is important to note that under GMP/GDP guidelines, the
responsibility for product quality and security still resides with the
product manufacturer. If a service provider is used, the sponsor should
demand greater visibility and transparency of operations, especially
in the area of environmental sustainability practices for Scope 1, 2 &
3 activities. Other recommended features should include: pay peruse,
built-in quality, and temperature monitoring of shipments with
reports and data management support.
Artificial Intelligence (AI) will emerge as a key player assisting or
performing many mainstream tasks formerly performed with human
intervention. This will deliver added value to the operation. The
addition of new materials developed from deep space research will
greatly increase performance capabilities. Note that AI has been in
use by some R&D groups and government agencies for almost twenty
years. AI can play a key role in data management, data analysis and
directed decision-making.
Overall, the expectations are changing to leverage a more stable
and reliable supply chain in a dynamic environment. The emerging
challenges will be in learning how to manage and adapt knowledge
using these new tools.
C. Ray Goff, Jr., PMP has over 35 years of proven achievements in leading
and innovating shipping systems and distribution projects
pharmaceutical firms.
for global
Ray retired as Director, Vaccine Development managing global clinical supply
& distribution for Pfizer and Wyeth Vaccines. Additionally, Ray was in technical
or management roles for: Abbott Labs, Bayer, Glaxo, Nortel Networks, and US
Army/ NATO.
Currently, as a Principal Engineer at Amgen, he enjoys solving challenges to
shipping systems, logistics, distribution and related emerging technologies.
Ray has authored many articles on: Cold Chain, Distribution, Shipping Systems,
and Reusable Shipping Programs.
pharmoutsourcing.com | 11 | April/May/June 2024
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Pharmaceutical Outsourcing Q2 2024

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