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4 September 2012

Qualified Person Association Database for Shared Audits “QPSHARE” comprises 284 API and Excipient Suppliers

Qualified Persons generally face the challenge to ensure that all API manufacturers and manufacturers supplying critical Excipients have been audited according to EU GMP regulations. However, the QP does not need to perform the audits on his/her own. But the QP must have a system in place which provides the necessary information (e.g. from an internal audit team or an external third party auditor).

For that reason the European Qualified Person Association initiated the shared audits database “QPSHARE” in 2010. It is the aim of the database to provide QPs with information for identifying suppliers other QPs are also interested in auditing in order to avoid duplication of work. HOWEVER, the QP Association does not perform any audits and is not involved in any details of the audit planning or commercial activities. The database is a free service for members of the Association and is therefore available for close to 1.700 QPs.

The QP Association Members can easily submit names and products of suppliers they want to audit any time. That way the database is continuously growing. Users can also see how many QPs are interested in a certain supplier for a defined product. But they can not see who these QPs are. A communication system in place allows the QPs to send a request to others interested in a certain supplier without seeing their names or e-mail addresses. The QPs who have been contacted can thus decide themselves whether they want to reply and to disclose their identity. In that case the QPs might decide to perform a joint audit or let one member perform the audit and share the audit report. Of course, the auditee needs to agree to this procedure.

The database currently contains 284 suppliers of APIs and Excipients. The following graphic shows the geographical distribution of the most important countries in the database

The evaluation also showed that 76% (216) of the suppliers are only mentioned once in the database. However, with every additional QP who is using the database the number of suppliers and the number of QPs interested in the same supplier will increase.