How to share Audits
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. QPSHARE is a free of charge database which is intended to help QPs when they want to audit certain suppliers (APIs, Excipients). Currently, almost 300 suppliers are listed in the database, most of them from China and India. Approx. 500 requests for shared audits have been created so far.
To find out more about this exclusive initiative for QP Association members please see the Q&As on QPSHARE.
Related GMP News
02.07.2025EFPIA Report on Current Inspections
18.06.2025FDA Warning Letter with Supplier Qualification Observations
11.06.2025Root Cause Investigations criticised at EU Company
21.05.2025More FDA Warning Letters citing Quality Oversight
21.05.2025New Version of GMP Auditors Handbook available
21.05.2025FDA: more unannounced Inspections also outside the US