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As much as necessary but as
little as possible,
.. this credo means that the actual situation has to
analysed very carefully so that the essentials are recognized
and actions planned according to their importance.
Our Offer
We provide and prepare
- An analysis of the current situation
(GMP mock inspection)
- A definition of the requirements (GMP
profile)
- An action catalogue
- A project plan (priorities and
time schedule)
Our procedure
During a first start-up meeting we define together with
you the essential conditions concerning GMP, dependent
on the type of product, its application, its specifications,
the type of production, the designated market place
and the type of production plant.
A detailed analysis of plant, premises,
production process, procedures, documentation and quality
standards will not only highlight weak points but also
point out optimisation potential and possible synergy
effects with already existing quality systems (e.g.
ISO 9000:2000).
In order to quantify the implementation
of the GMP requirements a first action catalogue is
created and discussed together with you.
It is the definition of priorities and
deadlines that turns an undertaking into a promising
project which can be judged by the management and assessed
with respect to the necessary resources.
Your Result
An overview of the actual pending activities in an action
catalogue, including priorities and target dates, that
can then serve as a basis for further cost estimation. |