For a shared audit (or joint audit) a number of customers requesting audits of the same supplier may group their requests and share the costs accordingly, decreasing the audit time and cost burden of suppliers facing similar audit requests from different clients.
On-site audits of active pharmaceutical ingredient manufacturers and suppliers are an expectation of all regulatory authorities and inspectorates. Although inspection reports by regulatory authorities — if available — can be taken into account when assessing a supplier, they do not replace a supplier audit performed by the pharmaceutical manufacturer or manufacturing authorisation holder, or its designated representative. Shared audits and third party audits where no conflict of interest is present are generally accepted by regulatory authorities. Such audits offer an enormous potential for reducing time and financial resources used for performing supplier audits.
The Audit Service Center also manages the confidentiality and non-disclosure contracts between different suppliers, contractors, and clients, so that the shared audit content and scope is defined and trusted for each involved party (e.g. patents, formula, material characteristic).
Shared audits are the easiest way for clients and suppliers to reduce risk and costs. Customers can use the QP Shared Audits Database for finding and setting up Shared Audits.
Using the QP Shared Audits Database
One of the most important tools in supplier qualification is the on-site audit. Although the QP is not obliged to perform the audit him- or herself, the responsibility stays with the QP. A possibility in saving resources is sharing an audit. For that reason the European QP Association initiated a database comprising shared audits information. To find out more about this exclusive initiative for QP Association members please visit the web-site of the European QP Association - www.qp-association.eu . More information on the database "QPSHARE" is available here.
To increase convenience when working with this tool, an advanced database "QPSHARE" was designed by the European QP Association. This new database now 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.
The database "QPSHARE" is a service of the European QP Association.
From this starting point shared audits can be managed, executed or supported by the independent Audit Service Center (third party auditors) between different QPs.