EU Directive 2004 27 EEC has been in force since 2004, according to which all active substances in European medicines must be produced according to GMP rules. The responsibility for monitoring lies with the Qualified Persons of the drug manufacturer, who must check GMP compliance using a supplier audit. This legal basis has led to the situation where the drug manufacturers check their suppliers of active agents using an audit of their GMP compliance.
In March 2005 the EMA decided that this inflation in customer audits can be counteracted in that drug manufacturers can delegate this supplier audit to a competent third party. It is at this point that Interactive Consulting Ass. GmbH comes in and has been offering third party audits for the last nine years.