GE Healthcare TRACERcenter - Manual (Page 3)

Pantone 376 C Pantone 260 C Pantone 144 C Pantone Process Cyan Pantone 215 C
For text: K:90%
A complete and
integrated GMP
equipment, service
and support platform
for the production of
PET tracers.
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.
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.
What is GMP?
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.
GMP • Good Manufacturing Practice
GMP compliant solutions
stand behind each patient dose.