It is a requirement within the EU that all investigational and medicinal products manufactured or imported by organisations holding a MA IMP, have a Qualified Person (QP) to approve and release each batch of IMP for usage in clinical trials.
At Sharp we offer well-established QP services, helping to streamline your product’s journey to trial and market in the EU, as well as giving you and your customers the confidence that your products have been manufactured to the very highest standards.
So what exactly is a Qualified Person? It’s someone who’s gained personal knowledge of the quality systems used at the manufacturing site, usually through an EU Good Manufacturing Practice Audit. QPs are assigned projects according to their specialist expertise and have personal and legal responsibility as defined by the EU Clinical Trial Directive (2001/20/EC).
Once a satisfactory audit is complete, your Sharp QP will issue a declaration that you can use to submit your Clinical Trial Authorisation (CTA). We can then work with you to manage the storage and distribution of your clinical trial supplies to your testing sites.