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Due to the Freedom of Information (FOI) it is possible to take a look at
the GMP deficiencies noticed by US-American FDA (Warning Letters). Thus, the
deficiencies can also be evaluated (see illustrations 1 and 2). A current
evaluation of the year 2000 (see illustration 3) can be found in GMP News
No. 120 of 24 July 2001.
Illustration 1: FDA Warning Letters 1999
Taken from: PharmInd 62, No. 7
(2000) Marrer GMP Inspections
Illustration 2:
Warning Letters 1999 regarding validation
Illustration 3
In comparison, one gets relatively
little information from European supervisory authorities.
In the following, we will
show you some exceptions.
John Taylor from the English
supervisory authority Medicines Control Agency (MCA) presented serious GMP
deficiencies of the years 2000/01 at the ECA event 'Auditor Education Course'
on 16-17 October 2001 in Copenhagen (illustrations 4 + 5).
Illustration 4
Illustration 5
It is also quite interesting
to compare the rankings of the years 1997/98 to 2000/01 (see illustration
6).
Illustration 6
Although there is no legal basis for this,
MCA also inspects API manufacturers according to ICH Guideline Q7a on a
voluntary basis. In the following we have listed the most frequent GMP deficiencies
in API manufacturing found by MCA:
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Handling of open
products in uncontrolled areas
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No regular
self-inspections
-
Labelling of the cleaning
status
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Incorrect change control
-
Inadequate
calibration or qualification
-
Insufficient process
validation
The Swiss supervisory
authority IKS has found quite similar GMP deficiencies in API manufacture:
In all evaluations it is
striking that there are deficiencies in the field of the QM system. Another
conspicuous feature is the relatively great number of deficiencies concerning the topic of
documentation. And last but not least, computer validation was mentioned in
nearly every inspection.
For this reason we offer
events which deal specifically with these problems:
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