Dear Mike,
I am surprised that you are surprised!!!!
Whether the report is 100% accurate or not will be revealed by
others. All I can say is that auditing companies in Europe and Asia
the thing that I find the most surprising is that in a single
jurisdiction you can find one factory which is really pretty good and
they are complaining that they recently had an inspection and they
had to deal with some minor point about calibration for example. You
travel a few hundred kilometers and walk into a plant which would be
acceptable for car repairs [OK so a slight exaggeration but not much].
The report quotes paint-I have twice seen walls being knocked down
and rebuilt while production carried on [tablet hardness was probably
OK from the cement powder!].
Now I am sure many of us have our own personal horror stories-so why
am I writing this? Because I really feel that there are indeed two
worlds out there. On the one hand regulators are talking about QbD,
design space, risk management and ICH Q10-all admirable things in
their own right. On the other hand there are still factories as
described in the article who probably think that painting the
facility while manufacturing is exactly what is meant by design
space!!!
All the best
Malcolm Ross
Generapharm-Training and Consultancy
Basel-CH
m.ross@generapharm.eu
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