29/30 September 2021
GMP News No. 144
12 November 2001
GMP Deficienciesin 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 relativelylittle information from European supervisory authorities.
In the following, we willshow you some exceptions.
John Taylor from the Englishsupervisory authority Medicines Control Agency (MCA) presented serious GMPdeficiencies 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 interestingto compare the rankings of the years 1997/98 to 2000/01 (see illustration6).
Although there is no legal basis for this,MCA also inspects API manufacturers according to ICH Guideline Q7a on avoluntary basis. In the following we have listed the most frequent GMP deficienciesin API manufacturing found by MCA:
The Swiss supervisoryauthority IKS has found quite similar GMP deficiencies in API manufacture:
In all evaluations it isstriking that there are deficiencies in the field of the QM system. Anotherconspicuous feature is the relatively great number of deficiencies concerning the topic ofdocumentation. And last but not least, computer validation was mentioned innearly every inspection.
For this reason we offerevents which deal specifically with these problems:
Writer: Sven Pommeranz,CONCEPT HEIDELBERG