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:

• 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

Further details can be found in the

• Cleaning Validation

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

• Computer Validation