EMEA publishes Guideline on Training and Qualification of GMP Inspectors

In the context of its Compilation of Community Procedures on Inspections and Exchange of Information, the EMEA drew up a guideline defining the training of GMP inspectors. Although directed only at GMP inspectors of the authorities of the member states, this document gives concrete hints for the training of GMP auditors in the companies.

What is interesting is the requirement that the GMP inspectors should have the same qualification as a Qualified Person under Directive 2001/83/EC and 2001/82/EC. However, these requirements have been implemented in different ways in the member states, so that now for inspectors, too, deviating requirements are implied.

The training itself is divided into 3 areas:

1.) basic training: apart from adequate inspection techniques, knowledge of the European law, but also of the activities of other organisations, like e.g. EDQM, ICH, PIC/S and WHO.
2.) further training: training by experienced inspectors and first participation in inspections
3.) continuous training: here knowledge of new technologies is also to be consolidated

The qualification and the performance of the inspectors are then to be continually assessed.

The document can be found here.

Hear John Taylor, Quality and Standards Manager Acting and Group Manager, Enforcement and Intelligence of the British Authority for Medicinal Products MHRA, speaking at the ECA Education Course How to Pass EU and FDA Inspections & GMP Compliance Auditor Course in Berlin from 8-10 June 2009 on the training of GMP inspectors.

Wolfgang Schmitt
On behalf of the European Compliance Academy (ECA)

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