GMP Deficiencies in Europe

GMP News No. 144

GMP News
12 November 2001

GMP Deficienciesin Europe

Due to the Freedom of Information (FOI) it is possible to take a look atthe GMP deficiencies noticed by US-American FDA (Warning Letters). Thus, thedeficiencies can also be evaluated (see illustrations 1 and 2). A currentevaluation of the year 2000 (see illustration 3) can be found in GMP NewsNo. 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 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).

Illustration 4

Illustration 5

It is also quite interestingto compare the rankings of the years 1997/98 to 2000/01 (see illustration6).

Illustration 6

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:

  • Handling of openproducts in uncontrolled areas

  • No regularself-inspections

  • Labelling of the cleaningstatus

  • Incorrect change control

  • Inadequatecalibration or qualification

  • Insufficient processvalidation

The Swiss supervisoryauthority IKS has found quite similar GMP deficiencies in API manufacture:

  • Risk of (cross)contamination

  • Self-inspections

  • Status labelling

  • Change control

  • Calibration

  • Tests on the finalproduct

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:


PharmInd 67, No. 7 (2000) Marrer GMP Inspections
GMP News 120, 24 July 2001, ECA
Auditor Education Course, memo script, October 2001, ECA

Writer: Sven Pommeranz,CONCEPT HEIDELBERG



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