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General
Information about using the
Global Info Centre
As you
access the Global Info Center
with your user id and password,
you will notice there are 5
services available at this time.
Each service is accessible to
you through an individual subscription.
The services are fully integrated
with the data being shared between
them and the services being
accessible from many different
points. Thus it is our goal
to develop a navigational system
that gives you fully integrated
access to all of the data regardless
of what service you are using.
We have accomplished this with
a color coded system of windows
and buttons.
The
DWCP, containing producers,
is identified in red. PathFinder,
containing end products of intermediates,
is identified in gold. FDA
Base, containing DMF and
VMF holders as well as approved
drug applications, is identified
in blue. WBDU, containing
users of bulk drugs, is identified
in green. As you access each
service, the color of the window
box outline changes to reflect
which service you are accessing.
The
system works as follows; Suppose
you have a subscription to DWCP,
PathFinder and FDA
Base. You are using the
DWCP and are searching
for producers of Lovastatin
for example. When Lovastatin
appears in the list, there will
be 3 colored circles next to
the product name Lovastatin.
These are yellow, blue and green.
If you are interested in producers
of Lovastatin, just click on
the name as you do now and you
will be shown the producers
because you are in the DWCP.
You know you are in the DWCP
because the window box is outlined
in red. However, if you were
interested in synthesis path
information, you would click
on the gold circle next to Lovastatin
and this will take you into
PathFinder and automatically
initiate a search for Lovastatin.
The color of the window box
outline will change to gold.
If you are interested in DMF
information for Lovastatin,
you would click on the blue
button next to the name Lovastatin.
This would take you into FDA
Base and automatically initiate
a search there for DMF/VMF holders
of Lovastatin. The color of
the window box outline would
automatically change to blue
telling you that you are accessing
information in the FDA Base
service. You can view the PathFinder
or FDA Base information
and then use the back button
to easily return to your place
in the DWCP.
The
data is integrated at a deeper
level as well. Suppose you continue
searching for producers of Lovastatin.
As you display a list of the
producers of Lovastatin, next
to the producer name appears
a blue circle IF the producing
company has a DMF or VMF on
file for this bulk pharmaceutical.
If you click on the blue circle,
you will see the details of
the DMF/VMF.
In
addition to DMFs and VMFs, FDA
Base also includes European
Certificates of Suitability.
Certificates of Suitability
are issued by the European Directorate
of Quality of Medicines. The
manufacturer has to submit a
full dossier to them on the
manufacturing method for the
substance and the impurities
that are associated with it
so that the reference to the
European Pharmacopoeia monograph
can be validated. The Certificate
of Suitability is then issued
to the manufacturer or the duly
authorized representative of
the manufacturer.
The
Certificates of Suitability
(COS) are designated as follows
in FDA Base and can be differentiated
from DMF/VMFs by one of the
following
1.
The identification number for
a COS is of the form 1999-012
while a DMF or VMF id a 5 digit
number.
2.
The type shown for a DMF is
II or IV. The type shown for
a VMF is "VMF". The
type show for a COS is "CS".
If
you are searching the DWCP and
see a blue circle next to the
producer of a chemical, this
means that they have either
a DMF, VMF, COS or some combination
of these. You need to click
on the blue circle to determine
exactly which is being held
by the company.
At
any point using the Global
Info Centre, you have an
option to view information from
the other services as long as
there is a colored circle shown
next to the data item of interest.
We
encourage you to experiment
with the buttons to see how
easily and efficiently you can
access a world of information.
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