Inspection Deficiencies regarding Validation and Qualification Aspects in EMEA Inspections
GMP News |
Inspection Deficiencies regarding Validation and Qualification Aspects in EMEA Inspections |
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:
In the overview about all GMP deficiencies in all inspections
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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Validation and qualification are
also the main subjects in the following ECA courses:,
Munich, Germany, 19-20 June 2007 The following courses concentrate on the validation of computer based systems: , Vienna, Austria, 24-26 April 2007 |
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