Inspection Deficiencies regarding Validation and Qualification Aspects in EMEA Inspections

Inspection Deficiencies regarding Validation and Qualification Aspects in EMEA Inspections

GMP News
21 March 2007

Inspection Deficiencies regarding Validation and Qualification Aspects in EMEA Inspections

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.


Validation and qualification are also the main subjects in the following ECA courses:, Munich, Germany, 19-20 June 2007
  • The Validation Manager
  • , Berlin, Germany, 10 - 12 October 2007

    The following courses concentrate on the validation of computer based systems:

    , Vienna, Austria, 24-26 April 2007
  • Integrating Analytical Equipment Qualification and Computerised System Validation
  • , Heidelberg, Germany, 18-19 June 2007
  • Computer Systems Validation Masterclass
  • , Heidelberg, Germany, 27-29 June 2007

    Sven Pommeranz
    On behalf of the European Compliance Academy (ECA)

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