According to European Legislations (Annex 16 to Eudralex – Volume 4 Good manufacturing practice (GMP) Guidelines; Directive 2001/83/EC) produced drug products need to be released by a Qualified Person (QP). The QP is solely responsible for the quality and safety of the released products. The QP needs to be independent of the production department. Furthermore he/she needs to be acknowledged as QP by the Dutch authorities (IGZ).
Also all Investigational Medicinal Products (IMPs) need to be released by a QP before they can be used in a clinical study (Annex 13 to Eudralex – Volume 4 Good manufacturing practice (GMP) Guidelines; Directive 2001/20/EC) .
Svinx Consultancy can deliver a temporary QP for you. Svinx Consultancy can also be hired as a back-up QP.