GMP News No. 144
12 November 2001
GMP Deficiencies in Europe
Illustration 1: FDA Warning Letters 1999
Taken from: PharmInd 62, No. 7 (2000) Marrer GMP Inspections
Illustration 2: Warning Letters 1999 regarding validation
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).
It is also quite interesting to compare the rankings of the years 1997/98 to 2000/01 (see 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:
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:
Writer: Sven Pommeranz, CONCEPT HEIDELBERG