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European Qualified Person Association - Publications/Question
and Answer Documents
Questions and Answers on Shared Audits Database "QPSHARE"
What is the QPSHARE?
QPSHARE is a free of charge database which is intended to help QPs when they want to audit certain suppliers (APIs, Excipients).
The approach of this project is very similar to a project that was initiated by different authorities (e. g. FDA, EMA, EDQM, TGA).
Here the different authorities tried to find companies more than one authority wants to audit.
By using the database you can identify suppliers other QPs are also interested in. QPSHARE will thus help you to communicate with each other.
So QPSHARE is a communication tool and will not initiate or organise audits.
How can QPSHARE help?
You may organise a joint audit or let another member perform the audit and share the audit report
if the auditee agrees to this procedure.
But as explained above: QPSHARE will only help you to identify and get in touch with other QPs interested in the same suppliers,
and the European QP Association is merely providing this tool and is not involved in these activities.
A special focus should be given to counterfeit activities. These criminal activities are an increasing problem every QP should be aware of.
Therefore, if you come across any counterfeit activities you should definitely share this information.
What is not the intension of QPSHARE?
- QPSHARE does not perform any audits
- QPSHARE is not involved in any details of an audit
- QPSHARE is not involved in any commercial activities
How des QPSHARE work?
We have asked QP Association Members to submit names and products of suppliers they want to audit. By entering this information
in the QPSHARE database it was possible to identify suppliers more than one QP Association Member is interested in.
Just go to the
list of suppliers.
So it is very simple: If you find a supplier you also want to audit, you can just click on “send request”.
Other QPs who expressed their interest in this supplier as well will be informed via our communication tool.
You can always see how many QPs are interested in a specific supplier but you will not see their name for confidentiality reasons.
What about confidentiality?
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 (“send a request”) 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 by directly contacting the colleague via e-mail.
How can a member add a supplier if the supplier is not already listed?
You can submit the information via a
contact form.
The supplier will then be added to the list within 48 hours.
Please note: To take advantage of this exclusive service you need to be logged in.
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