GE Healthcare TRACERcenter Brochure

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General Electric Company reserves the right to make
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GE Healthcare, a division of General Electric Company.

About GE Healthcare

GE Healthcare provides transformational medical technologies and services
that are shaping a new age of patient care. Our broad expertise in medical
imaging and information technologies, medical diagnostics, patient
monitoring systems, drug discovery, biopharmaceutical manufacturing
technologies, performance improvement and performance solutions services
help our customers to deliver better care to more people around the world at
a lower cost. In addition, we partner with healthcare leaders, striving to
leverage the global policy change necessary to implement a successful shift
to sustainable healthcare systems.

Our “healthymagination” vision for the future invites the world to join us on
our journey as we continuously develop innovations focused on reducing
costs, increasing access and improving quality around the world.
Headquartered in the United Kingdom, GE Healthcare is a unit of General
Electric Company (NYSE: GE). Worldwide, GE Healthcare employees are
committed to serving healthcare professionals and their patients in more than
100 countries. For more information about GE Healthcare, visit our website at
www.gehealthcare.com

GE Healthcare
3000 N. Grandview Blvd.
Waukesha, WI 53188
U.S.A.

TRACERcenter

One source. One complete solution.

www.gehealthcare.com

imagination at work

RDPH-0126-01.11-EN-US

GMP facilitation

Overall support

Local presence

Working together

What is TRACERcenter*?
One source. One complete solution.

GMP facilitation Technology expertise

Good Manufacturing Practice (GMP)
principles are fundamental to
everything we do at TRACERcenter. We
apply these critical quality guidelines to
your project from start to finish.
TRACERcenter helps you develop and
implement processes to fulfill your
facility’s GMP requirements.

We also offer you a comprehensive
portfolio of GMP-compatible accessories
and supplies that can help you stay in
compliance for many years to come.

TRACERcenter equips you with the right
platform for your needs-a platform that
combines innovative technologies with
products from some of the world’s
finest radiopharmaceutical suppliers.
You’ll be positioned to take full
advantage of advanced GE PETtrace*
cyclotrons and high-yield chemistry
synthesizers, and to integrate an
exceptional combination of third-party
hotcells, dispensers, quality control
instrumentation and
radiation-monitoring devices.

Local presence Overall support Working together

No matter where, no matter when,
uptime is critical. Our solution:
TRACERcenter equipment service. It
begins locally, so you’ll always have
someone on hand to meet your needs
promptly. Our service support extends
globally, to give you fast access to our
unique, worldwide service
infrastructure, through a single point of
contact. It’s comprehensive, including
everything from service contracts and
remote diagnostics to loaner
equipment and upgrade paths.

Technology expertise

GE Healthcare’s TRACERcenter is a unique hub that integrates technology, scientific expertise and clinical know-how to help put
you at the forefront of PET tracer production and imaging-anywhere in the world. Working closely with you to provide solutions
customized specifically to your PET research site or clinical center, we can provide you with all the support you need throughout
your program’s lifetime.

The result? A tracer-production and imaging center you’ll be free to operate with full confidence and complete peace of mind.

Setting up a state-of-the-art PET facility is admittedly a
challenge. TRACERcenter covers all the angles from qualifying
and validating your equipment, positioning you to manage all
the requisite paperwork, training your staff and providing
consulting services needed to make your program successful.

At TRACERcenter, we leave nothing to chance.

A successful PET tracer-production facility requires a major
investment and a long-term commitment-on your part, and on
ours. At GE Healthcare, we’re committed to helping the
healthcare community understand disease, from the beginning.
We’re backing up this commitment with investments not only in
research and development, but also in the infrastructure
required to provide you with all the support you need.

GMP • Good Manufacturing Practice

A complete and
integrated GMP
equipment, service
and support platform
for the production of
PET tracers.

What is GMP?

Good Manufacturing Practice (GMP) is
the part of a quality assurance system
which ensures that medicinal products
are consistently produced and
controlled to the quality standards
appropriate to their intended use.

GMP compliant solutions
stand behind each patient dose.

At GE Healthcare, adhering to GMP guidelines is mandatory
for our own pharmaceutical business. This means we have
the expertise and knowledge and are well positioned to help
you create and implement a customized GMP project - a
complete and integrated program designed to help enable
you to meet the requirements of your local authorities.

At every stage of your project, through concept, design, build,
documentation, training and the validation phases we can
assist you with pharmaceutical specialists using proven
pharmaceutical methodology to help you achieve a "GMP
operationally ready" facility.

We also offer a complete line of GMP compliant equipment,
accessories, supplies and a maintenance service to help you
maintain your GMP status.

Our goal: helping you to create a compliant GMP operation to
enhance the safety of your patients and meet the regulatory
bodies expectation.

To our knowledge, no one else can provide you with such a
comprehensive GMP solution.

Many countries have implemented
pharmaceutical legislation, and issued
guidelines on how to achieve
compliance with the principles set out
in their law. Whilst these guidelines are
not mandatory to follow, adherence to
the legislative principles is, and any
deviation from the guidance must
result in an equal or greater assurance
of product quality.

To achieve GMP, critical processes need
defining and documenting; equipment
and facilities need validating; people
need appropriate training, and the
entire operation needs to be controlled
under a robust Quality Management
System (QMS).

With PET manufacturing proliferating
worldwide, regulatory authorities are
increasing both PET GMP requirements
and their surveillance of the PET
producers. Such inspections can be
unannounced, therefore it is essential
that you remain in a state of
inspection readiness.