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12 January 2010

European QP Association To Release the Database "QPSHARE" Soon

The EU Qualified Person Association is in the final stage of releasing its database "QPSHARE" that will allow QPs to increase the efficiency of their companies’ supplier qualification with a unique tool. Dr. Bernd Renger, Chairman of the European QP Association, presented this information at the QP Forum in Barcelona on 4 December 2009.

The project started in April 2008 and aims to collect data about suppliers to identify API and excipients manufacturers who are of interest to more than one QP. In a first step QP Association members were asked to submit data about their suppliers using standardised Excel sheets, including name, country, address as well as the relevant products (APIs and excipients). These data were used to identify those suppliers more than one QP were interested in and to inform the QPs who named the supplier in question. Based on this information the QPs had the option to set up a joint audit of the supplier, e. g. by one of the QPs or by a third party, and to share the information. The approach of this project is very similar to that of a pilot project that was initiated by different authorities (e. g. FDA, EDQM, TGA) to identify those companies more than one authority wants to inspect. As a consequence, one authority might conduct an inspection and share the results with other partners.

The database "QPSHARE" is designed to display potential suppliers more than one QP is interested in. Members of the European QP Association are able to identify suppliers and the number of QPs interested in auditing the supplier. Confidentiality will be maintained, as the names of the QPs will not be displayed. If a member would like to contact the QPs related to a certain supplier, a button allows the member to send an automatic message to the other QPs. Only if the QPs who receive the message are interested they may disclose their identity and contact the colleague.

"QPSHARE" is an exclusive database for the members of the European QP Association. The organisation represents more than 1,200 QPs.

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