Shared Audit Setup with QPShare

Our latest recommendation: How to find and setup a shared audit with other companies and QPs?

At our CCS Audit Service Center we do reference to the “QPSHARE” database, which is provided to the members of the European QP Association (external link). The European QP Association initiated a database comprising shared audits information between Qualified Persons.

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, EMA, 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 QPSHARE database displays 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. Read more about QPSHARE.

If a common shared audit is found the audit plan, execution and reporting might be managed and controlled by the independent Third Party of Audit Service Center at CCS.