GMP Deficiencies in Europe

GMP News No. 144

GMP News
12 November 2001

GMP Deficiencies in Europe

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:

  • Handling of open products in uncontrolled areas

  • No regular self-inspections

  • Labelling of the cleaning status

  • Incorrect change control

  • Inadequate calibration or qualification

  • Insufficient process validation

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

  • Risk of (cross) contamination

  • Self-inspections

  • Status labelling

  • Change control

  • Calibration

  • Tests on the final product

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:

Hot Inspection Topic Our Conferences and Courses
Computer Validation
Quality Unit
Microbiological QC Unit
Batch Documentation

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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