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The
GMP-News from 21 February 2007
reported about a publication of the European Medicines Agency (EMEA),
describing the analysis of 435 inspections results in a 10-year period. We
examined this analysis relative to validation and qualification aspects,
yielding some interesting information.
The deficiency classification into
„critical", „major" and „other" refers to the Compilation of Community
Procedures. While „critical" deficiencies can harm users, „major"
deficiencies mainly focus on massive GMP or authorisation deviations.
Further, a combination of „major" deficiencies can also lead to a
„critical" deficiency, as well as a combination of „others" can become a
„major" deficiency. „Other" deficiencies cannot be integrated in the other
two classes, however, they usually indicate a GMP deviation.
The EMEA listed the GMP deficiencies in 40
different categories – among them the following deficiencies concerning
validation and qualification aspects:
- Analytical validation
- Calibration of measuring and test
equipment
- Cleaning validation
- Computerised systems – validation
- Equipment qualification (note: in the
article the term equipment validation is also mentioned)
- Process validation
In the overview about all GMP deficiencies
in all inspections
- Process validation ranks 9th
- Equipment validation ranks 12th
- Calibration of measuring and test
equipment ranks 19th
- Cleaning validation ranks 23rd
- Analytical validation ranks 31st
- Computerised systems – validation ranks
37th
The result for „critical" deficiencies
looks different; here process validation comes in 5th. The validation of
computer based systems is also mentioned (position 20), as well as
cleaning validation (on 23).
As far as „major" deficiencies are
concerned, equipment validation is on 9 and process validation on 14. For
the „other" deficiencies the positions are 10 (process validation) and 12
(equipment qualification). Under „others" calibration of measuring and
test equipment is listed on position 18.
Conclusion: Unfortunately the EMEA
publication does not allow a detailed analysis as it is possible with the
FDA Warning Letters (see
GMP News from 16
January 2007). Still,
it shows that process validation is an important part in the GMP
environment in Europe as well. Despite a different significance, the same
is true for qualification. Surprising is, though, that design aspects for
both facilities and equipment are on top of the list. Possibly this
indicates a higher relevance of design qualification within inspections?
Further details can be found in the
EMEA report.
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