GMP News Nr. 100
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2 April 2001
CD-ROM GMP Navigator 3.0 just released!
A service provided
by the European
Do you have enough
space to store these Guides?
The CD-ROM contains
630 Mb of GMP-related Guides from various authorities (EU,
FDA, ICH, PIC/S etc.). All in all the CD-ROM contains 16,112 pages. All documents
together would have a height of about 322.2 cm in total.
How long does it take
you to identify the requirements you are looking for? Hours? -
In order to search all documents
on the CD e.g. for all requirements regarding process validation, you need 3
seconds. Then you will be shown 117 Guides, recommendations and interpretations (e.g. FDA Warning Letters).
How does the CD work?
Find key words in one
This function is useful if you want to identify certain requirements in a Guide.
Suppose you want to find out where exactly the FDA guide to inspection
of high purity water systems defines design
requirements on material - just search for 'material' and
the relevant pages appear.
Search in all documents
If your question is:
"Which Guides define requirements on pharmaceutical water
systems?", just use the overall search function and type in
You will get a list of Guidelines
which contain the keyword. You can open the files and jump
directly to the relevant page. But more than
this. You will also
find interpretations like presentations of FDA investigators or
Warning Letters issued by the FDA.